Optimizing hydration with a low-sodium beverage

H2O - Hydration to be Optimized With a Low-sodium Beverage

This study is testing whether a new low-sodium drink with whey protein can keep healthy adults better hydrated than regular water.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (industry)
• Locations: 1 site (Lausanne)
• Trial ID: NCT06981468 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of a new low-sodium beverage containing whey protein and glycerol on hydration status in healthy adults. It is a single-center, double-blinded, three-arm crossover randomized controlled trial involving 45 participants. Each participant will consume one of the test beverages or a control (water) during three separate visits, with assessments conducted to measure hydration status. The goal is to determine if the new beverage formulations provide better hydration compared to standard water.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-50 with a BMI between 18.5 to 25 kg/m².

Not a fit: Patients with diagnosed medical conditions or those on medications affecting hydration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved hydration strategies for healthy adults.

How similar studies have performed: While hydration studies exist, this specific approach using whey protein and glycerol in a low-sodium beverage is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Female and male adults aged 18-50 years.
2. Body mass index (BMI) between 18.5 to 25 kg/m² (inclusive).
3. Healthy as determined based on self-reported medical history.
4. Able to understand and to sign a written informed consent prior to study enrolment.
5. Willing and able to comply with the requirements for participation in this study.

Exclusion Criteria:

1. 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.
2. 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).
3. Currently on a high-protein (1.5g/kg/BW/day) or ketogenic diet (based on self-report).
4. Known/suspected food allergy or intolerance to any food (based on self-report).
5. Female participants who are pregnant, lactating and/or breastfeeding (self-report or if in doubt, via urine pregnancy test).
6. 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.
7. Currently participating in another interventional study.
8. Family or hierarchical relationships with the research team members.

Where this trial is running

Lausanne

• Clinical Innovation Lab, Nestlé Research — Lausanne, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Nora Schneider — Nestlé Research
• Study coordinator: Marie-Pierre Pélissou

Conditions: Hydration Status, Hydration, Low-sodium beverage, H20