Clinical trial NCT06981468: Hydration To be Optimized (H2O) With a Low-sodium Beverage
Official title: H2O - Hydration to be Optimized With a Low-sodium Beverage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hydration Status
Keywords: Hydration
Low-sodium beverage
H20
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Fluid Retention (%) 1hr measure - fluid intake vs. urine output measurement
timeFrame: From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Fluid Retention (%) between interventional products - fluid intake vs. urine output measurement
timeFrame: From Baseline(Timepoint 0 minutes), to 1hr after baseline (Timepoint 60 minutes), and to 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Net Fluid Balance - fluid intake vs. urine output measurement, weighted on the scale
timeFrame: From Baseline (Timepoint 0 minutes) to 1hr after baseline(Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Urine weight - weighted on the scale
timeFrame: From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Cumulative Urine Weight - weighted on the scale
timeFrame: From Baseline (Timepoint 0 minutes) and at 2 hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Urine Specific Gravity (USG) - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730)
timeFrame: From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Change in USG from baseline to 1 and 2 hours - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730)
timeFrame: From Baseline (Timepoint 0 minutes) to 1hr after baseline (Timepoint 60 minutes), and at 2hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Change in calculated serum osmolality - by Blood Microsampling with Tasso Device
timeFrame: From Baseline (Timepoint 0 minutes), to 30min after baseline (Timepoint 30 minutes), to 1hr after baseline (Timepoint 60 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7)
measure: Hydration Questionnaire Part 1 - Visual Analogue Scale (VAS) Questionnaire (From 0-10cm, 0 indicating "not at all" and 10 indicating "extremely")
timeFrame: From Baseline (Timepoint 0 minutes), to 30min after baseline (Timepoint 30 minutes), to 1hr after baseline (Timepoint 60 minutes), and 2hrs after baseline (Timepoints 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7).
measure: Hydration Questionnaire Part 2 - Visual Analogue Scale (VAS) Questionnaire (Scale 0-10 cm, 0 indicating the worst score and 10 indicating the best score)
timeFrame: 5 minutes after Baseline (Timepoint 5 minutes), at 2 hrs after baseline (Timepoint 120 minutes), at Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7).
measure: Safety and Tolerability - Beverage Tolerability Questionnaire (Scale of 1-4, 1 indicating no symptoms and 4 indicating severe symptoms)
timeFrame: Prior to Baseline (Upon arrival on-site, before product intake), and at 2 hours after baseline (Timepoint 120 minutes), for Visit 1 (day 3), Visit 2 (day 5), and Visit 3 (day 7).
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Clinical Innovation Lab, Nestlé Research
Study officials:
affiliation: Nestlé Research
name: Nora Schneider
role: PRINCIPAL_INVESTIGATOR
References: