Hydration To be Optimized (H2O) With a Low-sodium Beverage (NCT06981468) | Clinical Trial Compass
CompletedNot Applicable
Hydration To be Optimized (H2O) With a Low-sodium Beverage
Switzerland43 participantsStarted 2025-04-16
Plain-language summary
In this study, the investigators want to assess the effects of a new beverage containing whey protein and glycerol (two different dosages) on hydration status in healthy adults when compared to the control (water).
This is a single-center, double-blinded, 3 arm cross-over randomized controlled study looking to enroll 45 healthy adult participants. The study will be performed at the Clinical Innovation Lab (CIL), Nestlé Research, Lausanne. Participants will be screened and randomly assigned to 1 of 6 sequences of consumption. Enrolled participants will have three visit days. They will consume one of the test products, or control at each visit and complete the study assessments.
Who can participate
Age range
18 Years – 50 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
. Female and male adults aged 18-50 years.
. Body mass index (BMI) between 18.5 to 25 kg/m² (inclusive).
. Healthy as determined based on self-reported medical history.
. Able to understand and to sign a written informed consent prior to study enrolment.
. Willing and able to comply with the requirements for participation in this study.
Exclusion criteria
. Any past or on-going diagnosed medical/surgical condition (e.g. malignancy, renal condition, liver condition, uncontrolled diabetes mellitus, cardiovascular disease, hypertension, migraine and headache disorders) and/ or psychiatric condition (e.g. depression, psychotic disorders, chronic insomnia, eating disorder), which in the opinion of the site physician/investigator may risk participant's well-being/safety, impede participant compliance with study procedures or ability to complete the study and/or could confound the primary objectives of the study.
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
Fluid Retention (%) - fluid intake vs. urine output measurement
Timeframe: From Baseline (Timepoint 0 minutes) to 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
. Current intake of medication/s that impact hydration status (e.g. anti-hypertensive medications, anti-diabetic medications, anti-psychotics, anti-depressants, diuretics, laxatives, antidiuretic hormone (ADH) antagonists, oral corticosteroids, glucocorticoids, anti-cholinergic medications, or cyclosporine A).
. Currently on a high-protein (1.5g/kg/BW/day) or ketogenic diet (based on self-report).
. Known/suspected food allergy or intolerance to any food (based on self-report).
. Female participants who are pregnant, lactating and/or breastfeeding (self-report or if in doubt, via urine pregnancy test).
. Any self-reported chronic alcohol or drug abuse within the past year; specifically, an average alcohol intake \> 2 standard drinks per day over a week for males, and \> 1 standard drink per day over a week for females. One standard drink contains 10-12 g of ethanol, i.e., 0.3 dl of strong alcohols, 1dl of wine, 3 dl of beer.
. Currently participating in another interventional study.
. Family or hierarchical relationships with the research team members.