DehydrationNCT05428761
Clinical Trial to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
A study testing TP1 and TP2 in people with Dehydration and Rehydration, run by Liquid I.V. at 1 site in United States.
Trial summary
Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Rehydration, Exercise Performance
- What is being tested?
- TP1 and TP2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Jan 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and female participants who are between 18 and 49 years of age (inclusive).
- Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit.
- Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
- Exercise regularly as per physical activity guidelines for Americans [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period.
- Can maintain their exercise status at the beginning of the study throughout the study period.
- Can achieve a peak VO2 at screening that is at least 60% of their age and gender matched normative value per American College of Sports Medicine recommendations.
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- Have normal or acceptable to to the investigator vital signs (BP and HR) at screening.
- Individuals with childbearing potential:
- Agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
- use for at least three months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), hormonal intrauterine devices (e.g., Mirena), or hormone implant (e.g., Norplant System); or
- use for at least one month prior to the first dose of study product: double-barrier method, non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that can result in pregnancy; or
- vasectomy of partner at least six months prior to the first dose of study product.
- Individuals with the potential to impregnate others:
- Agree to use condom or other acceptable methods to prevent pregnancy throughout the study.
- Complete abstinence from sexual intercourse that can result in pregnancy is also acceptable.
- Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Female participants who are lactating, pregnant or planning to become pregnant during the study. Carry a diagnosis of diabetes.
- Weigh less than or equal to 80 pounds at any visits.
- Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1).
- Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2).
- Participants must observe a 30-day washout period of no supplementation to be eligible. Consume more than two standard alcoholic drinks per day.
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- Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study.
- Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume. Smoking tobacco products.
- Have a history of alcohol or substance abuse in the 12 months prior to the screening visit.
- Are cognitively impaired and/or unable to give informed consent. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
- Have a current or previous diagnosis with COVID-19 in the three months prior to screening.
- Have had major surgery three months prior to screening or have a planned major surgery during the course of the study.
- Have received or use test product(s) in another research study in the 28 days prior to baseline visit (Familiarization Visit/Visit 2), or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study.
- Have any other active or unstable medical conditions or use medications, supplements, or therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency.
Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes.
The test products for this study, TP1 and TP2, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.
- Conditions
- Dehydration, Rehydration, Exercise Performance, Exercise Recovery, Fluid Balance, Cognitive Performance
- Being tested
- TP1, TP2, Placebo
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP1Other
Participants will receive TP1 during one experimental visit.
TP2Other
Participants will receive TP2 during one experimental visit.
PlaceboOther
Participants will receive placebo during one experimental visit.
| Study group | Role | What they receive |
|---|---|---|
| TP1 | Experimental | Participants will receive TP1 during one experimental trial. Receives: Other: TP1 |
| TP2 | Experimental | Participants will receive TP2 during one experimental trial. Receives: Other: TP2 |
| Placebo | Placebo comparator | Participants will receive placebo during one experimental trial. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative rehydration
To determine the effect of the Test Products (TPs) on relative rehydration after exercise, as compared to placebo via percent plasma volume change (hematocrit and hemoglobin) and plasma osmolality
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (3)
Hydration status
To determine the effect of the TPs on hydration status, as compared to placebo via sweat loss
Measured: Through study completion, an average of 8 weeks
Participant reported outcomes
To determine the effect of the TPs on participant reported outcomes, as compared to placebo via bloating, exertion, exhaustion, thermal sensation, feeling of refreshment, stomach upset, and thirst.
Measured: Through study completion, an average of 8 weeks
Plasma electrolyte levels
To determine the effect of the TPs on plasma electrolyte levels, as compared to placebo via sodium, potassium, magnesium, chloride, and calcium.
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liquid I.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc., University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Sean Arent, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428761
- Sponsor's protocol ID
- SOW4
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
- ClinicalTrials.gov ID
- NCT05428761
- Acronym / sponsor ID
- SOW4
- Conditions
- Dehydration, Rehydration, Exercise Performance, Exercise Recovery, Fluid Balance, Cognitive Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Liquid I.V.University, hospital or other
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc., University of South Carolina
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 23 Jun 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.
Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency.
Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes.
The test products for this study, TP1 and TP2, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TP1 | Experimental | Other: TP1Participants will receive TP1 during one experimental trial. |
| TP2 | Experimental | Other: TP2Participants will receive TP2 during one experimental trial. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo during one experimental trial. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy adult male and female participants who are between 18 and 49 years of age (inclusive).
- Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit.
- Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
- Exercise regularly as per physical activity guidelines for Americans [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period.
- Can maintain their exercise status at the beginning of the study throughout the study period.
Key exclusion criteria (14 listed)
- Female participants who are lactating, pregnant or planning to become pregnant during the study. Carry a diagnosis of diabetes.
- Weigh less than or equal to 80 pounds at any visits.
- Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1).
- Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2).
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 |
|---|---|---|
| TP1Participants will receive TP1 during one experimental visit. | Other | TP1 |
| TP2Participants will receive TP2 during one experimental visit. | Other | TP2 |
| PlaceboParticipants will receive placebo during one experimental visit. | Other | Placebo |
Primary outcome
Relative rehydration
Time frame: Through study completion, an average of 8 weeks
To determine the effect of the Test Products (TPs) on relative rehydration after exercise, as compared to placebo via percent plasma volume change (hematocrit and hemoglobin) and plasma osmolality
3 secondary outcomes
Hydration status
Time frame: Through study completion, an average of 8 weeks
Participant reported outcomes
Time frame: Through study completion, an average of 8 weeks
Plasma electrolyte levels
Time frame: Through study completion, an average of 8 weeks
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 25 Jan 2023.
- Individual participant dataSharing planned: No
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
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Hydration & Female Life Stages
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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.
Sean Arent, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TP1 and TP2 in people with Dehydration and Rehydration, run by Liquid I.V. 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 16 inclusion and 14 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 25 Jan 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?
Relative rehydration (time frame: Through study completion, an average of 8 weeks). 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 25 Jan 2023.