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Study of TP1 and TP2 for Rehydration After Exercise

This study is looking at how well two new hydration drinks, TP1 and TP2, help healthy adults rehydrate after exercise. Researchers will compare these drinks to a placebo (a drink with no active ingredients). You might be able to join if you are a healthy adult between 18 and 35 years old, in good general health, and have a body mass index (BMI) between 17.0 and 29.9 kg/m2. The main goal is to see how much each drink helps with rehydration, measured over about 8 weeks. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 16 healthy adults. Participants will receive TP1, TP2, and a placebo during different visits.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your rehydration will be measured through study completion, which is an average of 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05428228

Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

UNKNOWN
NAAges 18–35InterventionalBasic science
Liquid I.V.
~16 participants
Updated 2024-07-29 on ClinicalTrials.gov
What's tested:TP1TP2Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative rehydration
Measured over Through study completion, an average of 8 weeks

Conditions

Dehydration
Rehydration
Exercise Performance
Exercise Recovery
Cognitive Performance

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Richard Bloomer, PhD · PRINCIPAL_INVESTIGATOR · University of Memphis

Who to contact

Michael Lelko, MS
[email protected]
6787934226
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. Have normal or acceptable to the investigator vital signs (BP and HR) at screening. Individuals with childbearing potential: Agree to have urine pregnancy test performed on each trial day. 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.

Exclusion

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. 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.

What this trial measures

  • Relative rehydrationThrough 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 and plasma osmolality