SafetyNCT05592951
Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
A study testing Crystal Light (once serving), Liquid IV with amino acids (one serving) and Liquid IV with amino acids (two servings) in people with Safety and Tolerance, run by University of Memphis at 1 site in United States.
Trial summary
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Crystal Light (once serving), Liquid IV with amino acids (one serving) and Liquid IV with amino acids (two servings)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 18 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18-29.9 kg/m2
- able to fast overnight
Who cannot join
- tobacco user
- history of heart disease/cardiovascular disease
- hypertensive (140/90 mmHg or less)
- diabetes
- history of immune disorder
- history of kidney disease
Show all 19Show fewer
- hepatic impairment or disease
- history of unstable thyroid
- abnormality or obstruction of the gastrointestinal tract precluding swallowing
- abnormal digestion conditions
- previously diagnosed major affective disorder
- psychiatric disorder that required hospitalization in prior year
- history of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening)
- no known sensitivity or allergy to any of the study products
- consumption of alcohol-containing beverages within 24 hours of testing
- consumption of caffeine-containing beverages within 24 hours of testing
- active infection or illness of any kind
- if female, lactating, pregnant, or planning to become pregnant during the study
- receipt or use of an investigational product in another research study or change in medication, dietary supplementation, or significant change in diet/exercise regimen within 28 days prior to baseline/visit 2
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee, 38152
About this study
Official title: Randomized Trial to Assess the Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.
Read the detailed description
Maintaining adequate hydration is essential to optimal health, as well as athletic performance. When individuals exercise (in particular in a warm environment), they can lose excessive amounts of fluids along with necessary electrolytes (e.g., sodium, potassium, chloride) through sweating. With dehydration, individuals may feel sluggish and can experience impaired physical performance.
The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks (e.g., Gatorade, Powerade) -which also include small amounts of carbohydrate. The addition of amino acids to electrolyte solutions has previously been demonstrated to further increase the transport of water and sodium from the jejunum (small intestine). Separate research also showed an amino acid and electrolyte drink increased cellular hydration compared to flavored water and electrolyte only drinks. A 2019 study found that amino acids hydration increased beverage hydration index (BHI)-a measure of fluid balance following consumption of a beverage and was age dependent.
Amino acids supplementation has been popular for some time among athletes due to other potential performance benefits including changes to anabolic hormone levels, alterations to energy consumption, and mental endurance. Further, amino acids may reduce post-exercise muscle soreness and aid in recovery.
The electrolyte amino-acid test product is a powder provided in individual stick packs and contains L-Alanine and L-Glutamine as well as 5 essential vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. It is gluten-, soy-, and dairy-free, and provides electrolytes well below the daily value. The daily value (DV) tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. Liquid IV packets contain: sodium (510 mg, 22%DV) and potassium (380 mg, 8%DV). These packets contain a small percentage of the needed total electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.
- Being tested
- Crystal Light (once serving), Liquid IV with amino acids (one serving), Liquid IV with amino acids (two servings), Liquid IV with amino acids (three servings)
- Keywords
- Liquid IV, amino acids, electrolytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystal Light (once serving)Dietary supplement
Citric Acid, Potassium Citrate, Sodium Citrate, Aspartame (Phenylketonurics: Contains Phenylalanine), Magnesium Oxide, Maltodextrin, Contains Less than 2% of Natural Flavor, Acesulfame Potassium, Soy Lecithin, Yellow 5, Artificial Color.
Liquid IV with amino acids (one serving)Dietary supplement
Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
Liquid IV with amino acids (two servings)Dietary supplement
Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
Liquid IV with amino acids (three servings)Dietary supplement
Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium.
| Study group | Role | What they receive |
|---|---|---|
| Placebo once daily | Placebo comparator | 1 stick pack dissolved in water once daily prior to breakfast Receives: Dietary Supplement: Crystal Light (once serving) |
| Test beverage once daily | Experimental | 1 stick pack dissolved in water once daily prior to breakfast Receives: Dietary Supplement: Liquid IV with amino acids (one serving) |
| Test beverage twice daily | Experimental | 2 stick packs dissolved in water, one packet at a time twice daily (after lunch and after dinner) Receives: Dietary Supplement: Liquid IV with amino acids (two servings) |
| Test beverage three times daily | Experimental | 3 stick packs dissolved in water, one packet at a time three times daily (after breakfast, lunch, and dinner) Receives: Dietary Supplement: Liquid IV with amino acids (three servings) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
Measured: baseline
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
Measured: 2 weeks of assigned treatment
Alanine transaminase
Alanine transaminase measured as part of metabolic panel with units IU/L
Measured: 4 weeks of assigned treatment
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Measured: baseline
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Measured: 2 weeks of assigned treatment
Aspartate transferase
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Measured: 4 weeks of assigned treatment
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
Measured: baseline
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
Measured: 2 weeks of assigned treatment
Albumin
Albumin measured as part of comprehensive metabolic panel with units g/dL
Measured: 4 weeks of assigned treatment
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Measured: baseline
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Measured: 2 weeks of assigned treatment
Alkaline phosphatase
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Measured: 4 weeks of assigned treatment
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
Measured: baseline
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
Measured: 2 weeks of assigned treatment
total bilirubin
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
Measured: 4 weeks of assigned treatment
blood urea nitrogen mg/dL
blood urea nitrogen as part of comprehensive metabolic panel with unite
Measured: baseline
blood urea nitrogen
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
Measured: 2 weeks of assigned treatment
blood urea nitrogen
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
Measured: 4 weeks of assigned treatment
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
Measured: baseline
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
Measured: 2 weeks of assigned treatment
calcium
calcium as part of comprehensive metabolic panel with units mg/dL
Measured: 4 weeks of assigned treatment
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
Measured: baseline
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
Measured: 2 weeks of assigned treatment
carbon dioxide
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
Measured: 4 weeks of assigned treatment
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
Measured: baseline
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
Measured: 2 weeks of assigned treatment
chloride
chloride as part of comprehensive metabolic panel with units mmol/L
Measured: 4 weeks of assigned treatment
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
Measured: baseline
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
Measured: 2 weeks of assigned treatment
creatinine
creatinine as part of comprehensive metabolic panel with units mg/dL
Measured: 4 weeks of assigned treatment
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
Measured: baseline
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
Measured: 2 weeks of assigned treatment
estimated glomerular filtration rate calculation
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
Measured: 4 weeks of assigned treatment
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
Measured: baseline
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
Measured: 2 weeks of assigned treatment
blood glucose
glucose as part of comprehensive metabolic panel with units mg/dL
Measured: 4 weeks of assigned treatment
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
Measured: baseline
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
Measured: 2 weeks of assigned treatment
potassium
potassium as part of comprehensive metabolic panel with units mmol/L
Measured: 4 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL
total protein
Measured: baseline
total protein as part of comprehensive metabolic panel with units g/dL
total protein
Measured: 2 weeks of assigned treatment
total protein as part of comprehensive metabolic panel with units g/dL
total protein
Measured: 4 weeks of assigned treatment
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
Measured: baseline
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
Measured: 2 weeks of assigned treatment
sodium
sodium as part of comprehensive metabolic panel with units mmol/L
Measured: 4 weeks of assigned treatment
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
Measured: baseline
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
Measured: 2 weeks of assigned treatment
total globulin
total globulin as part of comprehensive metabolic panel with units g/dL
Measured: 4 weeks of assigned treatment
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
Measured: baseline
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
Measured: 2 weeks of assigned treatment
albumin/globulin ratio
albumin/globulin ratio as part of comprehensive metabolic panel
Measured: 4 weeks of assigned treatment
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Measured: baseline
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Measured: 2 weeks of assigned treatment
blood urea nitrogen/creatinine ratio
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Measured: 4 weeks of assigned treatment
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
Measured: baseline
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
Measured: 2 weeks of assigned treatment
Hematocrit
Hematocrit as part of complete blood count panel with differential test measured as percentage
Measured: 4 weeks of assigned treatment
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Measured: baseline
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Measured: 2 weeks of assigned treatment
hemoglobin
hemoglobin as part of complete blood count panel with differential test measured as g/dL
Measured: 4 weeks of assigned treatment
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
Measured: baseline
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
Measured: 2 weeks of assigned treatment
mean corpuscular volume
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
Measured: 4 weeks of assigned treatment
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
Measured: baseline
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
Measured: 2 weeks of assigned treatment
mean corpuscular hemoglobin concentration
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
Measured: 4 weeks of assigned treatment
White blood cell distribution (absolute)
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
Measured: baseline
White blood cell distribution (absolute)
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
Measured: 2 weeks of assigned treatment
White blood cell distribution (absolute)
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
Measured: 4 weeks of assigned treatment
White blood cell distribution (percentage)
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
Measured: baseline
White blood cell distribution (percentage)
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
Measured: 2 weeks of assigned treatment
White blood cell distribution (percentage)
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
Measured: 4 weeks of assigned treatment
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Measured: baseline
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Measured: 2 weeks of assigned treatment
Red cell distribution width
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Measured: 4 weeks of assigned treatment
platelet count
platelet count per microliter as part of complete blood count panel with differential test
Measured: baseline
platelet count
platelet count per microliter as part of complete blood count panel with differential test
Measured: 2 weeks of assigned treatment
platelet count
platelet count per microliter as part of complete blood count panel with differential test
Measured: 4 weeks of assigned treatment
red cell count
red cell count per microliter as part of complete blood count panel with differential test
Measured: baseline
red cell count
red cell count per microliter as part of complete blood count panel with differential test
Measured: 2 weeks of assigned treatment
red cell count
red cell count per microliter as part of complete blood count panel with differential test
Measured: 4 weeks of assigned treatment
white cell count
white cell count per microliter as part of complete blood count panel with differential test
Measured: baseline
white cell count
white cell count per microliter as part of complete blood count panel with differential test
Measured: 2 weeks of assigned treatment
white cell count
white cell count per microliter as part of complete blood count panel with differential test
Measured: 4 weeks of assigned treatment
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
Measured: baseline
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
Measured: 2 weeks of assigned treatment
Triiodothyronine
Triiodothyronine measured in blood as ng/dL
Measured: 4 weeks of assigned treatment
Thyroxine
Thyroxine measured in blood as ug/dL
Measured: baseline
Thyroxine
Thyroxine ug/dL measured in blood as ug/dL
Measured: 2 weeks of assigned treatment
Thyroxine
Thyroxine ug/dL measured in blood as ug/dL
Measured: 4 weeks of assigned treatment
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
Measured: baseline
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
Measured: 2 weeks of assigned treatment
thyroid stimulating hormone
Thyroxine measured in blood as micro-IU/dL
Measured: 4 weeks of assigned treatment
Urine Color
Urine color as reported in complete urinalysis
Measured: baseline
Urine Color
Urine color as reported in complete urinalysis
Measured: 2 weeks of assigned treatment
Urine Color
Urine color as reported in complete urinalysis
Measured: 4 weeks of assigned treatment
Urine appearance
Urine appearance as reported in complete urinalysis
Measured: baseline
Urine appearance
Urine appearance as reported in complete urinalysis
Measured: 2 weeks of assigned treatment
Urine appearance
Urine appearance as reported in complete urinalysis
Measured: 4 weeks of assigned treatment
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
Measured: baseline
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
Measured: 2 weeks of assigned treatment
Urine specific gravity
Urine specific gravity as reported in complete urinalysis
Measured: 4 weeks of assigned treatment
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
Measured: baseline
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
Measured: 2 weeks of assigned treatment
Urine potential of hydrogen
Urine potential of hydrogen (pH) as reported in complete urinalysis
Measured: 4 weeks of assigned treatment
Protein in urine
Protein, if present, measured in urine in complete urinalysis
Measured: baseline
Protein in urine
Protein, if present, measured in urine in complete urinalysis
Measured: 2 weeks of assigned treatment
Protein in urine
Protein, if present, measured in urine in complete urinalysis
Measured: 4 weeks of assigned treatment
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
Measured: baseline
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
Measured: 2 weeks of assigned treatment
Glucose in urine
Glucose, if present, measured in urine in complete urinalysis
Measured: 4 weeks of assigned treatment
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
Measured: baseline
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
Measured: 2 weeks of assigned treatment
Ketones in urine
Ketones, if present, measured in urine in complete urinalysis
Measured: 4 weeks of assigned treatment
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
Measured: baseline
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
Measured: 2 weeks of assigned treatment
Occult blood in urine
Occult blood, if present, measured in urine in complete urinalysis
Measured: 4 weeks of assigned treatment
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
Measured: baseline
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
Measured: 2 weeks of assigned treatment
White blood cell esterase in urine
White blood cell esterase, if present, measured in urine
Measured: 4 weeks of assigned treatment
Urine nitrite
nitrite, if present, measured in urine
Measured: baseline
Urine nitrite
nitrite, if present, measured in urine
Measured: 2 weeks of assigned treatment
Urine nitrite
nitrite, if present, measured in urine
Measured: 4 weeks of assigned treatment
bilirubin in urine
bilirubin, if present, measured in urine
Measured: baseline
bilirubin in urine
bilirubin, if present, measured in urine
Measured: 2 weeks of assigned treatment
bilirubin in urine
bilirubin, if present, measured in urine
Measured: 4 weeks of assigned treatment
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
Measured: baseline
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
Measured: 2 weeks of assigned treatment
urobilinogen in urine
urobilinogen in urine measured in urinalysis as mg/dL
Measured: 4 weeks of assigned treatment
Heart Rate
Heart Rate measured using an automated blood pressure machine
Measured: baseline
Heart Rate
Heart rate measured using an automated blood pressure machine
Measured: 2 weeks of assigned treatment
Heart Rate
Heart rate measured using an automated blood pressure machine
Measured: 4 weeks of assigned treatment
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Measured: baseline
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Measured: 2 weeks of assigned treatment
Blood Pressure
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Measured: 4 weeks of assigned treatment
Product Tolerability questionnaire (gastrointestinal)
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Measured: baseline
Product Tolerability questionnaire (gastrointestinal)
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Measured: 2 weeks of assigned treatment
Product Tolerability questionnaire (gastrointestinal)
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Measured: 4 weeks of assigned treatment
Product Tolerability questionnaire (consumption)
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
Measured: baseline
Product Tolerability questionnaire (consumption)
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
Measured: 2 weeks of assigned treatment
Product Tolerability questionnaire (consumption)
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
Measured: 4 weeks of assigned treatment visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 3 days before baseline visit
Daily food diary
A list of all food and drink consumed that day
Measured: 3 days before baseline visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 2 days before baseline visit
Daily food diary
A list of all food and drink consumed that day
Measured: 2 days before baseline visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 1 day before baseline visit
Daily food diary
A list of all food and drink consumed that day
Measured: 1 day before baseline visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 3 days before 2 week visit
Daily food diary
A list of all food and drink consumed that day
Measured: 3 days before 2 week visit
Daily food diary
A list of all food and drink consumed that day
Measured: 2 days before 2 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 2 days before 2 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 1 day before 2 week visit
Daily food diary
A list of all food and drink consumed that day
Measured: 1 day before 2 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 3 days before 4 week visit
Daily food diary
A list of all food and drink consumed that day
Measured: 3 days before 4 week visit
tolerability questionnaire
A list of all food and drink consumed that day along with a Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 2 days before 4 week visit
Daily food diary
A list of all food and drink consumed that day
Measured: 2 days before 4 week visit
tolerability questionnaire
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Measured: 1 day before 4 week visit
Daily food diary
A list of all food and drink consumed that day
Measured: 1 day before 4 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start30 Sep 2022
- Primary completion14 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Principal investigator, Richard Bloomer, University of Memphis
- Investigators
- Richard Bloomer, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592951
- Sponsor's protocol ID
- PRO-FY2023-5
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess the Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05592951
- Acronym / sponsor ID
- PRO-FY2023-5
- Keywords
- Liquid IV, amino acids, electrolytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.
Detailed description
Maintaining adequate hydration is essential to optimal health, as well as athletic performance. When individuals exercise (in particular in a warm environment), they can lose excessive amounts of fluids along with necessary electrolytes (e.g., sodium, potassium, chloride) through sweating. With dehydration, individuals may feel sluggish and can experience impaired physical performance.
The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks (e.g., Gatorade, Powerade) -which also include small amounts of carbohydrate. The addition of amino acids to electrolyte solutions has previously been demonstrated to further increase the transport of water and sodium from the jejunum (small intestine). Separate research also showed an amino acid and electrolyte drink increased cellular hydration compared to flavored water and electrolyte only drinks. A 2019 study found that amino acids hydration increased beverage hydration index (BHI)-a measure of fluid balance following consumption of a beverage and was age dependent.
Amino acids supplementation has been popular for some time among athletes due to other potential performance benefits including changes to anabolic hormone levels, alterations to energy consumption, and mental endurance. Further, amino acids may reduce post-exercise muscle soreness and aid in recovery.
The electrolyte amino-acid test product is a powder provided in individual stick packs and contains L-Alanine and L-Glutamine as well as 5 essential vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. It is gluten-, soy-, and dairy-free, and provides electrolytes well below the daily value. The daily value (DV) tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. Liquid IV packets contain: sodium (510 mg, 22%DV) and potassium (380 mg, 8%DV). These packets contain a small percentage of the needed total electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.
The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Placebo once daily | Placebo comparator | Dietary Supplement: Crystal Light (once serving)1 stick pack dissolved in water once daily prior to breakfast |
| Test beverage once daily | Experimental | Dietary Supplement: Liquid IV with amino acids (one serving)1 stick pack dissolved in water once daily prior to breakfast |
| Test beverage twice daily | Experimental | Dietary Supplement: Liquid IV with amino acids (two servings)2 stick packs dissolved in water, one packet at a time twice daily (after lunch and after dinner) |
| Test beverage three times daily | Experimental | Dietary Supplement: Liquid IV with amino acids (three servings)3 stick packs dissolved in water, one packet at a time three times daily (after breakfast, lunch, and dinner) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 18-29.9 kg/m2
- able to fast overnight
Key exclusion criteria (19 listed)
- tobacco user
- history of heart disease/cardiovascular disease
- hypertensive (140/90 mmHg or less)
- diabetes
- history of immune disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystal Light (once serving)Citric Acid, Potassium Citrate, Sodium Citrate, Aspartame (Phenylketonurics: Contains Phenylalanine), Magnesium Oxide, Maltodextrin, Contains Less than 2% of Natural Flavor, Acesulfame Potassium, Soy Lecithin, Yellow 5, Artificial Color. | Dietary supplement | Placebo once daily |
| Liquid IV with amino acids (one serving)Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium. | Dietary supplement | Test beverage once daily |
| Liquid IV with amino acids (two servings)Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium. | Dietary supplement | Test beverage twice daily |
| Liquid IV with amino acids (three servings)Allulose, L-Alanine, L-Glutamine, Citric Acid, Sodium chloride, Lemon Lime Flavorings, Potassium Citrate, Trisodium Citrate Dihydrate, Dipotassium Phosphate, Syloid Silicon Dioxide, Stevia, Vitamin C, Vitamin B3, Calcium Pantothenate B5 (Vitamin B5), Vitamin B6, Vitamin B12. Liquid IV packets contain: sodium and potassium. | Dietary supplement | Test beverage three times daily |
Primary outcome
Alanine transaminase
Time frame: baseline
Alanine transaminase measured as part of metabolic panel with units IU/L
Alanine transaminase
Time frame: 2 weeks of assigned treatment
Alanine transaminase measured as part of metabolic panel with units IU/L
Alanine transaminase
Time frame: 4 weeks of assigned treatment
Alanine transaminase measured as part of metabolic panel with units IU/L
Aspartate transferase
Time frame: baseline
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Aspartate transferase
Time frame: 2 weeks of assigned treatment
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Aspartate transferase
Time frame: 4 weeks of assigned treatment
Aspartate transferase measured as part of comprehensive metabolic panel with units IU/L
Albumin
Time frame: baseline
Albumin measured as part of comprehensive metabolic panel with units g/dL
Albumin
Time frame: 2 weeks of assigned treatment
Albumin measured as part of comprehensive metabolic panel with units g/dL
Albumin
Time frame: 4 weeks of assigned treatment
Albumin measured as part of comprehensive metabolic panel with units g/dL
Alkaline phosphatase
Time frame: baseline
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Alkaline phosphatase
Time frame: 2 weeks of assigned treatment
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
Alkaline phosphatase
Time frame: 4 weeks of assigned treatment
Alkaline phosphatase measured as part of comprehensive metabolic panel with units IU/L
total bilirubin
Time frame: baseline
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
total bilirubin
Time frame: 2 weeks of assigned treatment
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
total bilirubin
Time frame: 4 weeks of assigned treatment
total bilirubin measured as part of comprehensive metabolic panel with units mg/dL
blood urea nitrogen mg/dL
Time frame: baseline
blood urea nitrogen as part of comprehensive metabolic panel with unite
blood urea nitrogen
Time frame: 2 weeks of assigned treatment
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
blood urea nitrogen
Time frame: 4 weeks of assigned treatment
blood urea nitrogen as part of comprehensive metabolic panel with units mg/dL
calcium
Time frame: baseline
calcium as part of comprehensive metabolic panel with units mg/dL
calcium
Time frame: 2 weeks of assigned treatment
calcium as part of comprehensive metabolic panel with units mg/dL
calcium
Time frame: 4 weeks of assigned treatment
calcium as part of comprehensive metabolic panel with units mg/dL
carbon dioxide
Time frame: baseline
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
carbon dioxide
Time frame: 2 weeks of assigned treatment
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
carbon dioxide
Time frame: 4 weeks of assigned treatment
carbon dioxide as part of comprehensive metabolic panel with units mmol/L
chloride
Time frame: baseline
chloride as part of comprehensive metabolic panel with units mmol/L
chloride
Time frame: 2 weeks of assigned treatment
chloride as part of comprehensive metabolic panel with units mmol/L
chloride
Time frame: 4 weeks of assigned treatment
chloride as part of comprehensive metabolic panel with units mmol/L
creatinine
Time frame: baseline
creatinine as part of comprehensive metabolic panel with units mg/dL
creatinine
Time frame: 2 weeks of assigned treatment
creatinine as part of comprehensive metabolic panel with units mg/dL
creatinine
Time frame: 4 weeks of assigned treatment
creatinine as part of comprehensive metabolic panel with units mg/dL
estimated glomerular filtration rate calculation
Time frame: baseline
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
estimated glomerular filtration rate calculation
Time frame: 2 weeks of assigned treatment
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
estimated glomerular filtration rate calculation
Time frame: 4 weeks of assigned treatment
estimated glomerular filtration rate calculation as part of comprehensive metabolic panel with units mL/min/1.73
blood glucose
Time frame: baseline
glucose as part of comprehensive metabolic panel with units mg/dL
blood glucose
Time frame: 2 weeks of assigned treatment
glucose as part of comprehensive metabolic panel with units mg/dL
blood glucose
Time frame: 4 weeks of assigned treatment
glucose as part of comprehensive metabolic panel with units mg/dL
potassium
Time frame: baseline
potassium as part of comprehensive metabolic panel with units mmol/L
potassium
Time frame: 2 weeks of assigned treatment
potassium as part of comprehensive metabolic panel with units mmol/L
potassium
Time frame: 4 weeks of assigned treatment
potassium as part of comprehensive metabolic panel with units mmol/L
total protein as part of comprehensive metabolic panel with units g/dL
Time frame: baseline
total protein
total protein as part of comprehensive metabolic panel with units g/dL
Time frame: 2 weeks of assigned treatment
total protein
total protein as part of comprehensive metabolic panel with units g/dL
Time frame: 4 weeks of assigned treatment
total protein
sodium
Time frame: baseline
sodium as part of comprehensive metabolic panel with units mmol/L
sodium
Time frame: 2 weeks of assigned treatment
sodium as part of comprehensive metabolic panel with units mmol/L
sodium
Time frame: 4 weeks of assigned treatment
sodium as part of comprehensive metabolic panel with units mmol/L
total globulin
Time frame: baseline
total globulin as part of comprehensive metabolic panel with units g/dL
total globulin
Time frame: 2 weeks of assigned treatment
total globulin as part of comprehensive metabolic panel with units g/dL
total globulin
Time frame: 4 weeks of assigned treatment
total globulin as part of comprehensive metabolic panel with units g/dL
albumin/globulin ratio
Time frame: baseline
albumin/globulin ratio as part of comprehensive metabolic panel
albumin/globulin ratio
Time frame: 2 weeks of assigned treatment
albumin/globulin ratio as part of comprehensive metabolic panel
albumin/globulin ratio
Time frame: 4 weeks of assigned treatment
albumin/globulin ratio as part of comprehensive metabolic panel
blood urea nitrogen/creatinine ratio
Time frame: baseline
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
blood urea nitrogen/creatinine ratio
Time frame: 2 weeks of assigned treatment
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
blood urea nitrogen/creatinine ratio
Time frame: 4 weeks of assigned treatment
blood urea nitrogen/creatinine ratio as part of comprehensive metabolic panel
Hematocrit
Time frame: baseline
Hematocrit as part of complete blood count panel with differential test measured as percentage
Hematocrit
Time frame: 2 weeks of assigned treatment
Hematocrit as part of complete blood count panel with differential test measured as percentage
Hematocrit
Time frame: 4 weeks of assigned treatment
Hematocrit as part of complete blood count panel with differential test measured as percentage
hemoglobin
Time frame: baseline
hemoglobin as part of complete blood count panel with differential test measured as g/dL
hemoglobin
Time frame: 2 weeks of assigned treatment
hemoglobin as part of complete blood count panel with differential test measured as g/dL
hemoglobin
Time frame: 4 weeks of assigned treatment
hemoglobin as part of complete blood count panel with differential test measured as g/dL
mean corpuscular volume
Time frame: baseline
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
mean corpuscular volume
Time frame: 2 weeks of assigned treatment
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
mean corpuscular volume
Time frame: 4 weeks of assigned treatment
mean corpuscular volume as part of complete blood count panel with differential test measured as femtoliter
mean corpuscular hemoglobin concentration
Time frame: baseline
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
mean corpuscular hemoglobin concentration
Time frame: 2 weeks of assigned treatment
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
mean corpuscular hemoglobin concentration
Time frame: 4 weeks of assigned treatment
mean corpuscular hemoglobin concentration as part of complete blood count panel with differential test measured as g/dL
White blood cell distribution (absolute)
Time frame: baseline
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
White blood cell distribution (absolute)
Time frame: 2 weeks of assigned treatment
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
White blood cell distribution (absolute)
Time frame: 4 weeks of assigned treatment
absolute measures of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes per microliter as part of complete blood count panel
White blood cell distribution (percentage)
Time frame: baseline
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
White blood cell distribution (percentage)
Time frame: 2 weeks of assigned treatment
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
White blood cell distribution (percentage)
Time frame: 4 weeks of assigned treatment
percentages of white blood cells (neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes out of total white blood cells.
Red cell distribution width
Time frame: baseline
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Red cell distribution width
Time frame: 2 weeks of assigned treatment
red cell distribution width as part of complete blood count panel with differential test measured as percentage
Red cell distribution width
Time frame: 4 weeks of assigned treatment
red cell distribution width as part of complete blood count panel with differential test measured as percentage
platelet count
Time frame: baseline
platelet count per microliter as part of complete blood count panel with differential test
platelet count
Time frame: 2 weeks of assigned treatment
platelet count per microliter as part of complete blood count panel with differential test
platelet count
Time frame: 4 weeks of assigned treatment
platelet count per microliter as part of complete blood count panel with differential test
red cell count
Time frame: baseline
red cell count per microliter as part of complete blood count panel with differential test
red cell count
Time frame: 2 weeks of assigned treatment
red cell count per microliter as part of complete blood count panel with differential test
red cell count
Time frame: 4 weeks of assigned treatment
red cell count per microliter as part of complete blood count panel with differential test
white cell count
Time frame: baseline
white cell count per microliter as part of complete blood count panel with differential test
white cell count
Time frame: 2 weeks of assigned treatment
white cell count per microliter as part of complete blood count panel with differential test
white cell count
Time frame: 4 weeks of assigned treatment
white cell count per microliter as part of complete blood count panel with differential test
Triiodothyronine
Time frame: baseline
Triiodothyronine measured in blood as ng/dL
Triiodothyronine
Time frame: 2 weeks of assigned treatment
Triiodothyronine measured in blood as ng/dL
Triiodothyronine
Time frame: 4 weeks of assigned treatment
Triiodothyronine measured in blood as ng/dL
Thyroxine
Time frame: baseline
Thyroxine measured in blood as ug/dL
Thyroxine
Time frame: 2 weeks of assigned treatment
Thyroxine ug/dL measured in blood as ug/dL
Thyroxine
Time frame: 4 weeks of assigned treatment
Thyroxine ug/dL measured in blood as ug/dL
thyroid stimulating hormone
Time frame: baseline
Thyroxine measured in blood as micro-IU/dL
thyroid stimulating hormone
Time frame: 2 weeks of assigned treatment
Thyroxine measured in blood as micro-IU/dL
thyroid stimulating hormone
Time frame: 4 weeks of assigned treatment
Thyroxine measured in blood as micro-IU/dL
Urine Color
Time frame: baseline
Urine color as reported in complete urinalysis
Urine Color
Time frame: 2 weeks of assigned treatment
Urine color as reported in complete urinalysis
Urine Color
Time frame: 4 weeks of assigned treatment
Urine color as reported in complete urinalysis
Urine appearance
Time frame: baseline
Urine appearance as reported in complete urinalysis
Urine appearance
Time frame: 2 weeks of assigned treatment
Urine appearance as reported in complete urinalysis
Urine appearance
Time frame: 4 weeks of assigned treatment
Urine appearance as reported in complete urinalysis
Urine specific gravity
Time frame: baseline
Urine specific gravity as reported in complete urinalysis
Urine specific gravity
Time frame: 2 weeks of assigned treatment
Urine specific gravity as reported in complete urinalysis
Urine specific gravity
Time frame: 4 weeks of assigned treatment
Urine specific gravity as reported in complete urinalysis
Urine potential of hydrogen
Time frame: baseline
Urine potential of hydrogen (pH) as reported in complete urinalysis
Urine potential of hydrogen
Time frame: 2 weeks of assigned treatment
Urine potential of hydrogen (pH) as reported in complete urinalysis
Urine potential of hydrogen
Time frame: 4 weeks of assigned treatment
Urine potential of hydrogen (pH) as reported in complete urinalysis
Protein in urine
Time frame: baseline
Protein, if present, measured in urine in complete urinalysis
Protein in urine
Time frame: 2 weeks of assigned treatment
Protein, if present, measured in urine in complete urinalysis
Protein in urine
Time frame: 4 weeks of assigned treatment
Protein, if present, measured in urine in complete urinalysis
Glucose in urine
Time frame: baseline
Glucose, if present, measured in urine in complete urinalysis
Glucose in urine
Time frame: 2 weeks of assigned treatment
Glucose, if present, measured in urine in complete urinalysis
Glucose in urine
Time frame: 4 weeks of assigned treatment
Glucose, if present, measured in urine in complete urinalysis
Ketones in urine
Time frame: baseline
Ketones, if present, measured in urine in complete urinalysis
Ketones in urine
Time frame: 2 weeks of assigned treatment
Ketones, if present, measured in urine in complete urinalysis
Ketones in urine
Time frame: 4 weeks of assigned treatment
Ketones, if present, measured in urine in complete urinalysis
Occult blood in urine
Time frame: baseline
Occult blood, if present, measured in urine in complete urinalysis
Occult blood in urine
Time frame: 2 weeks of assigned treatment
Occult blood, if present, measured in urine in complete urinalysis
Occult blood in urine
Time frame: 4 weeks of assigned treatment
Occult blood, if present, measured in urine in complete urinalysis
White blood cell esterase in urine
Time frame: baseline
White blood cell esterase, if present, measured in urine
White blood cell esterase in urine
Time frame: 2 weeks of assigned treatment
White blood cell esterase, if present, measured in urine
White blood cell esterase in urine
Time frame: 4 weeks of assigned treatment
White blood cell esterase, if present, measured in urine
Urine nitrite
Time frame: baseline
nitrite, if present, measured in urine
Urine nitrite
Time frame: 2 weeks of assigned treatment
nitrite, if present, measured in urine
Urine nitrite
Time frame: 4 weeks of assigned treatment
nitrite, if present, measured in urine
bilirubin in urine
Time frame: baseline
bilirubin, if present, measured in urine
bilirubin in urine
Time frame: 2 weeks of assigned treatment
bilirubin, if present, measured in urine
bilirubin in urine
Time frame: 4 weeks of assigned treatment
bilirubin, if present, measured in urine
urobilinogen in urine
Time frame: baseline
urobilinogen in urine measured in urinalysis as mg/dL
urobilinogen in urine
Time frame: 2 weeks of assigned treatment
urobilinogen in urine measured in urinalysis as mg/dL
urobilinogen in urine
Time frame: 4 weeks of assigned treatment
urobilinogen in urine measured in urinalysis as mg/dL
Heart Rate
Time frame: baseline
Heart Rate measured using an automated blood pressure machine
Heart Rate
Time frame: 2 weeks of assigned treatment
Heart rate measured using an automated blood pressure machine
Heart Rate
Time frame: 4 weeks of assigned treatment
Heart rate measured using an automated blood pressure machine
Blood Pressure
Time frame: baseline
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Blood Pressure
Time frame: 2 weeks of assigned treatment
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Blood Pressure
Time frame: 4 weeks of assigned treatment
Systolic and Diastolic blood pressure measured using an automated blood pressure machine
Product Tolerability questionnaire (gastrointestinal)
Time frame: baseline
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Product Tolerability questionnaire (gastrointestinal)
Time frame: 2 weeks of assigned treatment
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Product Tolerability questionnaire (gastrointestinal)
Time frame: 4 weeks of assigned treatment
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the past two weeks from 0 (None) to 10 (severe)
Product Tolerability questionnaire (consumption)
Time frame: baseline
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
Product Tolerability questionnaire (consumption)
Time frame: 2 weeks of assigned treatment
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
Product Tolerability questionnaire (consumption)
Time frame: 4 weeks of assigned treatment visit
Questionnaire that can be scored 1-5 (1 bad quality to 5 good quality): with answers of strongly agree, agree, neutral, disagree, and strongly agree for tastes pleasant, easy to drink, easy on stomach, would purchase, dissolves easily, too gritty, too sticky and excessively, mildly too much, optimal, mildly too little, and extremely lacking for sweet, sour, salty, bitter. Final question on after taste with answers of pleasant, ok, no taste, unpleasant, extremely unpleasant.
tolerability questionnaire
Time frame: 3 days before baseline visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 3 days before baseline visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 2 days before baseline visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 2 days before baseline visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 1 day before baseline visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 1 day before baseline visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 3 days before 2 week visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 3 days before 2 week visit
A list of all food and drink consumed that day
Daily food diary
Time frame: 2 days before 2 week visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 2 days before 2 week visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
tolerability questionnaire
Time frame: 1 day before 2 week visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 1 day before 2 week visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 3 days before 4 week visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 3 days before 4 week visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 2 days before 4 week visit
A list of all food and drink consumed that day along with a Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 2 days before 4 week visit
A list of all food and drink consumed that day
tolerability questionnaire
Time frame: 1 day before 4 week visit
Visual analog scale used to assess gastrointestinal issues (bloating, constipation, diarrhea, frequent urination, gas, nausea, stomach fullness, abdominal pain/cramping) over the day (None) to 10 (severe)
Daily food diary
Time frame: 1 day before 4 week visit
A list of all food and drink consumed that day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Bloomer, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystal Light (once serving), Liquid IV with amino acids (one serving) and Liquid IV with amino acids (two servings) in people with Safety and Tolerance, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine transaminase (time frame: baseline). The study lists 159 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.