About this trial
The aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
TP1
Other interventionParticipants will be administered TP1 during one of the experimental visits.
TP2
Other interventionParticipants will be administered TP2 during one of the experimental visits.
Placebo
Other interventionParticipants will be administered placebo during one of the experimental visits.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Hydration status via sweat loss
To determine the effect of the TPs on hydration status, as compared to placebo via sweat loss
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
Other outcomes
Relative effects of dehydration and rehydration
To explore the relative effects of dehydration and rehydration from the TPs and control on cognitive function, as compared to placebo via NIH cognitive toolbox - Flanker inhibitory control and attention testing performance
Exercise performance
To explore the effect of the TPs on exercise performance, as compared to placebo via time to exhaustion
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liquid I.V.
Lead sponsor
University of Memphis
Collaborator