DehydrationNCT03559101
Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status
A study testing Distilled water, Medical Food 1 and Medical Food 2 in people with Dehydration, run by W. Larry Kenney at 1 site in United States.
Trial summary
Older adults typically do not drink later in the day to avoid the necessity of interrupting sleep to urinate. Sometimes they also limit ingestion of fluids to avoid the need to urinate when engaged in certain activities such as traveling or attending an event. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Distilled water, Medical Food 1 and Medical Food 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2017to 18 Dec 2017
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-30 years or ≥60 years
Who cannot join
- cardiovascular, renal, or digestive diseases
- pregnancy
- breastfeeding
- smoking and/or use of nicotine-containing products
- illegal/recreational drug use
- medications that alter fluid balance (e.g., diuretics)
- allergy to Latex
- men with prostate issues that interfere with urination.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Characterization of the Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status in Young and Older Subjects
Older adults typically do not drink later in the day to avoid the necessity of interrupting sleep to urinate. Sometimes they also limit ingestion of fluids to avoid the need to urinate when engaged in certain activities such as traveling or attending an event. Therefore, beverages that have greater fluid retention in the body leading to a more sustained positive hydration status could be advantageous in such situations. The composition of a beverage as well as other factors such as volume ingested and metabolism of components can affect the retention of the fluid in the body. Age may be another factor. The beverage hydration index (BHI), first described in 2016, was used to indicate the hydration response to thirteen well-known beverages in young male adults. The current study assesses the BHI of four beverages and how that response is affected by age following the standardized protocol. The four beverages have been chosen for inclusion in this study because they have been used by older adults to prevent dehydration.
Read the detailed description
Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles, as well as measures of liver and renal function. The subjects are assigned to one of two groups based upon age.
Subjects participate in five experimental trials, one for each of the five beverages. The beverages are commercially-available and contain ingredients that are generally recognized as safe (GRAS). The order of the beverages is randomized. The list of ingredients on the bottle containing the beverage is obscured. The trials are identical and separated by at least five days. For each experiment, baseline measurements are conducted. Then the subjects consume one liter of the test beverage over thirty minutes. Additional measurements are performed thirty minutes post ingestion and then every hour for four hours post ingestion.
This study yields two BHI numbers for each beverage, one number for each study-group. The BHI numbers are indicative of the amount of fluid remaining in the body four hours after consumption of the beverage. The BHI number is inversely related to the amount of urine produced over the four hours. A greater BHI number indicates better fluid retention and maintenance of plasma volume.
- Conditions
- Dehydration
- Being tested
- Distilled water, Medical Food 1, Medical Food 2, Pedialyte, Gatorade
- Keywords
- Hydration, Plasma Volume, Amino acids, Glucose, Electrolytes, Fluid Retention, Aging, Beverage Hydration Index, Dehydration, Oral Rehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distilled waterOther
Commercially available beverage
Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Medical Food 1Other
Commercially available beverage
Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Medical Food 2Other
Commercially available beverage
Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
PedialyteOther
Commercially available beverage
Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
GatoradeOther
Commercially available beverage
Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
| Study group | Role | What they receive |
|---|---|---|
| Beverage 1 - Control | Active comparator | Distilled Water Receives: Other: Distilled water |
| Beverage 2 | Experimental | Medical Food 1 (8 amino acids, 60 mmol/L Na, 20 mmol/L K + citrate, Cl) Receives: Other: Medical Food 1 |
| Beverage 3 | Experimental | Medical Food 2 (8 amino acids, 30 mmol/L Na, 10 mmol/L K + citrate, Cl) Receives: Other: Medical Food 2 |
| Beverage 4 | Experimental | Pedialyte Receives: Other: Pedialyte |
| Beverage 5 | Experimental | Gatorade Receives: Other: Gatorade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beverage hydration index (BHI)
Indicative of amount of fluid remaining in body four hours post consumption of beverage. Inversely related to amount of urine produced over 4 hours. Larger BHI number indicates better fluid retention and maintenance of plasma volume.
Measured: One BHI for each beverage for each age group is calculated and reported through study completion, an average of 1 year.
Secondary outcomes (2)
Body Mass
Body weight measured on scale
Measured: Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Urine Mass
Weight of urine produced
Measured: Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start25 May 2017
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies 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
- Crossover
- Model description
- Two groups of subjects (young, older) participate in five experiments, one for each of five beverage pretreatments. Pretreatments are consumed immediately prior to the experiment. The experiments are conducted in randomized order. The trials are identical and separated by at least five days.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- W. Larry Kenney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, W. Larry Kenney, Penn State University
- Investigators
- William L Kenney, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559101
- Sponsor's protocol ID
- STUDY6412
- Status last verified
- Jun 2018
- First submitted
- 22 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clarke MM, Stanhewicz AE, Wolf ST, Cheuvront SN, Kenefick RW, Kenney WL. A randomized trial to assess beverage hydration index in healthy older adults. Am J Clin Nutr. 2019 Jun 1;109(6):1640-1647. doi: 10.1093/ajcn/nqz009.
PubMed 31051498
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Effects of Amino Acid/Electrolyte-based Beverages on Hydration Status in Young and Older Subjects
- ClinicalTrials.gov ID
- NCT03559101
- Acronym / sponsor ID
- STUDY6412
- Conditions
- Dehydration
- Keywords
- Hydration, Plasma Volume, Amino acids, Glucose, Electrolytes, Fluid Retention, Aging, Beverage Hydration Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- W. Larry KenneyUniversity, hospital or other
- Study start
- 25 May 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 15 Jun 2018 (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.
Older adults typically do not drink later in the day to avoid the necessity of interrupting sleep to urinate. Sometimes they also limit ingestion of fluids to avoid the need to urinate when engaged in certain activities such as traveling or attending an event. Therefore, beverages that have greater fluid retention in the body leading to a more sustained positive hydration status could be advantageous in such situations. The composition of a beverage as well as other factors such as volume ingested and metabolism of components can affect the retention of the fluid in the body. Age may be another factor. The beverage hydration index (BHI), first described in 2016, was used to indicate the hydration response to thirteen well-known beverages in young male adults. The current study assesses the BHI of four beverages and how that response is affected by age following the standardized protocol. The four beverages have been chosen for inclusion in this study because they have been used by older adults to prevent dehydration.
Detailed description
Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles, as well as measures of liver and renal function. The subjects are assigned to one of two groups based upon age.
Subjects participate in five experimental trials, one for each of the five beverages. The beverages are commercially-available and contain ingredients that are generally recognized as safe (GRAS). The order of the beverages is randomized. The list of ingredients on the bottle containing the beverage is obscured. The trials are identical and separated by at least five days. For each experiment, baseline measurements are conducted. Then the subjects consume one liter of the test beverage over thirty minutes. Additional measurements are performed thirty minutes post ingestion and then every hour for four hours post ingestion.
This study yields two BHI numbers for each beverage, one number for each study-group. The BHI numbers are indicative of the amount of fluid remaining in the body four hours after consumption of the beverage. The BHI number is inversely related to the amount of urine produced over the four hours. A greater BHI number indicates better fluid retention and maintenance of plasma volume.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Two groups of subjects (young, older) participate in five experiments, one for each of five beverage pretreatments. Pretreatments are consumed immediately prior to the experiment. The experiments are conducted in randomized order. The trials are identical and separated by at least five days.
| Arm | Type | Receives |
|---|---|---|
| Beverage 1 - Control | Active comparator | Other: Distilled waterDistilled Water |
| Beverage 2 | Experimental | Other: Medical Food 1Medical Food 1 (8 amino acids, 60 mmol/L Na, 20 mmol/L K + citrate, Cl) |
| Beverage 3 | Experimental | Other: Medical Food 2Medical Food 2 (8 amino acids, 30 mmol/L Na, 10 mmol/L K + citrate, Cl) |
| Beverage 4 | Experimental | Other: PedialytePedialyte |
| Beverage 5 | Experimental | Other: GatoradeGatorade |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-30 years or ≥60 years
Key exclusion criteria (8 listed)
- cardiovascular, renal, or digestive diseases
- pregnancy
- breastfeeding
- smoking and/or use of nicotine-containing products
- illegal/recreational drug use
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 |
|---|---|---|
| Distilled waterCommercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption | Other | Beverage 1 - Control |
| Medical Food 1Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption | Other | Beverage 2 |
| Medical Food 2Commercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption | Other | Beverage 3 |
| PedialyteCommercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption | Other | Beverage 4 |
| GatoradeCommercially available beverage Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption | Other | Beverage 5 |
Primary outcome
Beverage hydration index (BHI)
Time frame: One BHI for each beverage for each age group is calculated and reported through study completion, an average of 1 year.
Indicative of amount of fluid remaining in body four hours post consumption of beverage. Inversely related to amount of urine produced over 4 hours. Larger BHI number indicates better fluid retention and maintenance of plasma volume.
2 secondary outcomes
Body Mass
Time frame: Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
Urine Mass
Time frame: Baseline before consumption of beverage and then 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption
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 15 Jun 2018.
- Derived from this study: PubMed 31051498Clarke MM, Stanhewicz AE, Wolf ST, Cheuvront SN, Kenefick RW, Kenney WL. A randomized trial to assess beverage hydration index in healthy older adults. Am J Clin Nutr. 2019 Jun 1;109(6):1640-1647. doi: 10.1093/ajcn/nqz009.
Related trials for Dehydration
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Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
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Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
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Hydration & Female Life Stages
Dehydration, Menstruation
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.
William L Kenney, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distilled water, Medical Food 1 and Medical Food 2 in people with Dehydration, run by W. Larry Kenney 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 1 inclusion and 8 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 15 Jun 2018. 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. 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?
Beverage hydration index (BHI) (time frame: One BHI for each beverage for each age group is calculated and reported through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559101, which also lists 1 linked publication.
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 15 Jun 2018.