Evaluating new hydration beverages for rehydration after exercise
A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
This study tests if two new hydration drinks can help healthy adults rehydrate better after exercise compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Liquid I.V. Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05428228 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of two novel hydration beverage formulas in promoting rehydration in healthy adults following exercise. Participants will be randomly assigned to receive either one of the hydration products or a placebo. The study will measure various outcomes related to rehydration, exercise performance, and cognitive performance. Healthy adults aged 18 to 49 who meet specific health and exercise criteria will be eligible to participate.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 49 who regularly engage in structured exercise and meet specific health criteria.
Not a fit: Patients with uncontrolled diseases or conditions, or those outside the specified age and BMI range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hydration strategies that enhance recovery and performance for active individuals.
How similar studies have performed: While hydration strategies are commonly studied, the specific formulations being tested in this trial represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Memphis, Tennessee
- The University of Memphis — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Richard Bloomer, PhD — University of Memphis
- Study coordinator: Michael Lelko, MS
- Email: michael.lelko@liquid-iv.com
- Phone: 6787934226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.