H2O – Hydration to Optimize with a Low Sodium Beverage
Summary description of the study
Hydration is important for our health as it supports many bodily functions and allows our organs to function optimally. The body typically loses about 2.6 liters of water per day through urine, skin, breathing, and feces. If these losses are not replaced by water intake, in the form of beverages or food, there is a risk of dehydration. Unfortunately, most current hydration solutions contain sugars and sodium, which can contribute to cardio-metabolic diseases. A new hydration solution containing whey protein, glycerol, and water has shown promising results in improving hydration status in studies involving cats and dogs. In this study, we aim to examine the effect of this new solution on hydration in healthy adults. The study will be conducted with 45 participants at the Clinical Innovation Laboratory following a double-blind, randomized, crossover design. Participants will therefore consume the 3 products (2 active products and 1 control).
(BASEC)
Intervention under investigation
Comparator 1 Glycerol dose 1 and proteins
Comparator 2: Glycerol dose 2 and proteins
Placebo
(BASEC)
Disease under investigation
Dehydration
(BASEC)
1. Adult males and females aged 18 to 50 years. 2. Body Mass Index (BMI) between 18.5 and 25 kg/m² (inclusive). 3. In good health, as determined based on self-reported medical history. 4. Able to understand and sign a written informed consent before enrollment in the study. 5. Willing and able to comply with the requirements for participation in this study. (BASEC)
Exclusion criteria
1. Any diagnosed past or current medical/surgical condition (e.g., malignancy, kidney disease, liver disease, uncontrolled diabetes, cardiovascular disease, hypertension, migraines, and head disorders) and/or psychiatric condition (e.g., depression, psychotic disorders, chronic insomnia, eating disorders), which, in the opinion of the site physician/investigator, could jeopardize the participant's well-being/safety, hinder the participant's compliance with study procedures or their ability to complete the study, and/or could confound the primary objectives of the study. 2. Current use of medications impacting hydration status (e.g., antihypertensive medications, antidiabetic medications, antipsychotics, antidepressants, diuretics, laxatives, antidiuretic hormone (ADH) antagonists, oral corticosteroids, glucocorticoids, anticholinergic medications, or cyclosporine A). 3. Currently following a high-protein diet (1.5 g/kg/BW/day) or a ketogenic diet. 4. Known/suspected food allergy or intolerance to any food (based on self-report). 5. Female participants who are pregnant, breastfeeding, and/or currently lactating (self-report or, in case of doubt, via a urine pregnancy test). 6. Any self-reported chronic alcohol or drug abuse in the past year; specifically, an average alcohol consumption of > 2 standard drinks per day over a week for men, and > 1 standard drink per day over a week for women. A standard drink contains 10-12 g of ethanol, which is 0.3 dl of spirits, 1 dl of wine, or 3 dl of beer. 7. Currently participating in another interventional study. 8. Family or hierarchical relationships with members of the research team. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
Société des Produits Nestlé SA
(BASEC)
Contact
Contact Person Switzerland
Dr. Nora Schneider
+41 21 785 92 60
nora.schneider@clutterrdls.nestle.comClinical Research Unit, Clinical Innovation Lab
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
03.03.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
H2O – Hydration to be Optimized with a low-sodium beverage (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available