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

Study Overview
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Brief Summary
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The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.

Official Title
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A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

Conditions
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Dehydration, Rehydration, Exercise Performance, Exercise Recovery, Cognitive Performance

Intervention / Treatment
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* Other: TP1
* Other: TP2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TP1<br>Participants will be administered TP1 during one of the experimental visits. | Other: TP1<br>* Participants will be administered TP1 during one of the experimental visits.<br>|
| Experimental: TP2<br>Participants will be administered TP2 during one of the experimental visits. | Other: TP2<br>* Participants will be administered TP2 during one of the experimental visits.<br>|
| Placebo Comparator: Placebo<br>Participants will be administered placebo during one of the experimental visits. | Other: Placebo<br>* Participants will be administered placebo during one of the experimental visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and plasma osmolality | Through study completion, an average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydration status via sweat loss | To determine the effect of the TPs on hydration status, as compared to placebo via sweat loss | Through study completion, an average of 8 weeks | 
| Participants 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 | Through study completion, an average of 8 weeks |