Actively Recruiting
A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
Led by Liquid I.V. · Updated on 2024-07-29
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Liquid I.V.
Lead Sponsor
U
University of Memphis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two new hydration beverage formulas for rehydration after exercise in healthy adults. The study aims to compare these products to a placebo in improving hydration status and related outcomes such as exercise recovery and cognitive performance. The trial is randomized, double-blind, and crossover in design, sponsored by Liquid I.V. Participants will receive one of the two hydration products, called TP1 and TP2, or a placebo during separate experimental visits. Each participant experiences all three conditions at different times. The study spans an average of 8 weeks during which these treatments are administered and assessed. Throughout the study, participants will be monitored for relative rehydration, hydration status through sweat loss, and self-reported outcomes. Various assessments will be conducted regularly to measure these effects. The study includes healthy adults aged 18 to 35 years who exercise regularly and meet specific health criteria. Safety and adherence are tracked during the visits, with all procedures designed to evaluate the hydration effects of the tested beverages.
CONDITIONS
Brief Title
Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult males and females between 18 and 49 years old (inclusive)
- Good general health with no active or uncontrolled diseases
- Body mass index between 17.0 and 29.9 kg/m2 (inclusive)
- Regular exercise of 150 to 500 minutes per week and willing to maintain this level
- Peak VO2 at screening at least 60% of age and gender matched normative value
- Normal or acceptable vital signs (blood pressure and heart rate) at screening
- Females with childbearing potential agree to urine pregnancy tests on each trial day
- Able and willing to consent, understand questionnaires, and follow study procedures
You will not qualify if you...
- Females who are pregnant, lactating, or planning pregnancy during the study
- Diagnosis of diabetes
- Weighing 80 pounds or less at any visit
- Positive answers on screening questionnaire indicating exclusion
- History of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease
- Major affective disorder or psychiatric hospitalization in prior year
- Immune disorders such as HIV/AIDS
- Cancer except localized skin cancer or in situ cervical cancer within 5 years
- Use of dietary supplements affecting hydration within 30 days prior to baseline
- Consumption of more than two standard alcoholic drinks per day
- Use of inhalable or smokable substances including cigarettes, vaporizers, water pipes, or cannabis within 30 days prior or during the study
- Medical conditions impacting ability to exercise or ingest prescribed fluid volume
- Smoking tobacco products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive three different hydration beverages including two novel formulas and a placebo on separate experimental visits.
3 experimental visits (in-person)
Trial Site Locations
Total: 1 location
1
The University of Memphis
Memphis, Tennessee, United States, 38152
Actively Recruiting
Research Team
M
Michael Lelko, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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