Hydration To be Optimized (H2O) With a Low-sodium Beverage

NCT06981468 | Completed

• 1 other identifier: 2309NR
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration Status

Keywords

Hydration; Low-sodium beverage; H20

Outcome Measures

Primary Outcomes (1)

• Fluid Retention (%) - fluid intake vs. urine output measurement

  Difference in fluid retention 2 hours after intake of the study product in comparison with the control by measuring urine output in comparison to fluid intake.

  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 (11)

• Fluid Retention (%) 1hr measure - fluid intake vs. urine output measurement

  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)

• Fluid Retention (%) between interventional products - fluid intake vs. urine output measurement

  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)

• Net Fluid Balance - fluid intake vs. urine output measurement, weighted on the scale

  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)

• Urine weight - weighted on the scale

  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)

• Cumulative Urine Weight - weighted on the scale

  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)

Study Arms (3)

Interventional Product 1

ACTIVE COMPARATOR

Glycerol (Dose 1) and Whey Protein

Dietary Supplement: Low Sodium Beverage 1

Interventional Product 2

ACTIVE COMPARATOR

Glycerol (Dose 2) and Whey Protein

Dietary Supplement: Low Sodium Beverage 2

Comparator

PLACEBO COMPARATOR

Water

Other: Control (placebo) group

Interventions

Low Sodium Beverage 1 DIETARY_SUPPLEMENT

The first interventional product for this study is a low-sodium beverage containing Dose 1 of glycerol, whey protein, and water. It will come in a ready to drink format for the participants.

Interventional Product 1

Low Sodium Beverage 2 DIETARY_SUPPLEMENT

The second interventional product for this study is a low-sodium beverage containing dose 2 of glycerol, whey protein, and water. It will come in a ready to drink format for the participants.

Interventional Product 2

Control (placebo) group OTHER

Water

Comparator

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Innovation Lab, Nestlé Research

Lausanne, Switzerland

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Nora Schneider

  Nestlé Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 20, 2025
• Study Start: April 16, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CH (1)