General information
  • Disease category Other (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Lausanne
    (BASEC)
  • Contact Dr. Nora Schneider nora.schneider@rdls.nestle.com (BASEC)
  • Data Source(s) BASEC: Import from 13.06.2025 ICTRP: N/A
  • Last update 13.06.2025 15:15
HumRes66503 | SNCTP000006303 | BASEC2024-02444

H2O – Hydration to Optimize with a Low Sodium Beverage

  • Disease category Other (BASEC)
  • Recruitment status recruitment ongoing (BASEC/ICTRP)
  • Trial sites
    Lausanne
    (BASEC)
  • Contact Dr. Nora Schneider nora.schneider@rdls.nestle.com (BASEC)
  • Data Source(s) BASEC: Import from 13.06.2025 ICTRP: N/A
  • Last update 13.06.2025 15:15

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)

Criteria for participation in trial
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)

not available

Sponsor

Société des Produits Nestlé SA

(BASEC)

Contact

Contact Person Switzerland

Dr. Nora Schneider

+41 21 785 92 60

nora.schneider@rdls.nestle.com

Clinical 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

not available

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