A Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydrati… (NCT07564661) | Clinical Trial Compass
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A Clinical Trial to Explore the Efficacy of Two Investigational Products on Post-Exercise Hydration in Recreationally Active Healthy Adults
Canada32 participantsStarted 2026-05-01
Plain-language summary
The goal of this clinical trial is to explore the efficacy of two investigational products for promoting post-exercise hydration in recreationally active healthy adults. The main question it aims to answer is: Does consumption of each investigational product (IP) beverage, compared to control beverages, result in differences in blood hematocrit and serum osmolality at 0.5, 2, 4, and 8 hours post-exercise in recreationally active healthy adults? Researchers will compare two IPs to control beverages to see if the IPs are effective for supporting post-exercise hydration. Participants will be required to consume the IPs, as well as control beverages. Participants will also complete questionnaires, undergo an exercise challenge, and record their food and beverage intake.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females between 18 and 65 years of age
. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
. Physically fit for exercise, as assessed by the Physical Activity Readiness Questionnaire (PAR-Q), and is willing and able to complete the exercise challenge throughout the study
. Self-reported hard or very hard aerobic exercise of ≥30 and ≤150 minutes per week, as assessed by the Stanford 7-Day Physical Activity Recall at screening
. Agrees to maintain usual physical activity level for the duration of the study and not to engage in vigorous physical activity for at least 24 hours prior to each clinic visit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Blood Hematocrit
Timeframe: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
2
Change in Serum Osmolality
Timeframe: 0.5-, 2-, 4-, and 8-hours post-exercise from visit 2 to visit 5
. Agrees to abstain from alcohol consumption for at least 48 hours prior to each clinic visit and caffeine consumption and physical exercise on the morning of each study visit
. Agrees to adhere to the dietary guidelines for the duration of the study, inclusive of the run-in period
. Agrees to maintain current lifestyle habits (diet, medications, supplements, and sleep) as much as possible throughout the study
Exclusion criteria
. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
. Allergy, sensitivity, intolerance, or dietary restriction, including dairy sensitivity/intolerance, preventing consumption of investigational product, comparator/control ingredients, or standardized meal
. Self-reported unstable weight for the past 3 months defined as having gained or lost more than 5% of body weight prior to baseline
. Poor venous access as assessed by the QI
. Unstable metabolic disease or chronic diseases as assessed by the QI
. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
. Type I or Type II diabetes and diabetes insipidus