Hydration StatusH2ONCT06981468
Hydration To be Optimized (H2O) With a Low-sodium Beverage
A study testing Low Sodium Beverage 1 and Low Sodium Beverage 2 in people with Hydration Status, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration Status
- What is being tested?
- Low Sodium Beverage 1 and Low Sodium Beverage 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Apr 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: H2O - Hydration to be Optimized With a Low-sodium Beverage
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
- Being tested
- Low Sodium Beverage 1, Low Sodium Beverage 2, Control (placebo) group
- Keywords
- Hydration, Low-sodium beverage, H20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sodium Beverage 1Dietary 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.
Low Sodium Beverage 2Dietary 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.
Control (placebo) groupOther
Water
| Study group | Role | What they receive |
|---|---|---|
| Interventional Product 1 | Active comparator | Glycerol (Dose 1) and Whey Protein Receives: Dietary Supplement: Low Sodium Beverage 1 |
| Interventional Product 2 | Active comparator | Glycerol (Dose 2) and Whey Protein Receives: Dietary Supplement: Low Sodium Beverage 2 |
| Comparator | Placebo comparator | Water Receives: Other: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Difference in fluid retention 1 hour after intake of the study product in comparison with the control by measuring urine output in comparison to fluid intake.
Measured: 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
Difference in fluid retention at 1hour and 2hours after intake of the study product, comparing both study products containing the different doses of glycerol.
Measured: 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
Net fluid balance at 1 hour and 2 hours after intake of study product, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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
Urine weight at 1 hour after intake and cumulative urine weight after 2 hours of intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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
The cumulative urine weight 2 hours after intake of the study products relative to the cumulative urine weight 2 hours after intake of the control (Beverage Hydration Index [BHI]), comparing both study products containing different doses of glycerol.
Measured: 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)
Urine Specific Gravity (USG) - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730)
USG 1 and 2 hours after intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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)
Change in USG from baseline to 1 and 2 hours - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730)
Change in USG from baseline to 1 and 2 hours after intake (delta0-60min, delta0-120min) after intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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)
Change in calculated serum osmolality - by Blood Microsampling with Tasso Device
Change in calculated serum osmolality during 30-minute and 1 hour after intake of the study products, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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)
Hydration Questionnaire Part 1 - Visual Analogue Scale (VAS) Questionnaire (From 0-10cm, 0 indicating "not at all" and 10 indicating "extremely")
Hydration Questionnaire Part 1 Visual Analogue Scale (VAS) scores at 30 minutes, 1 hour, and 2 hours after intake of the study product, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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).
Hydration Questionnaire Part 2 - Visual Analogue Scale (VAS) Questionnaire (Scale 0-10 cm, 0 indicating the worst score and 10 indicating the best score)
Hydration Questionnaire Part 2 ratings, comparing the study products with the control, and between both study products containing different doses of glycerol.
Measured: 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).
Safety and Tolerability - Beverage Tolerability Questionnaire (Scale of 1-4, 1 indicating no symptoms and 4 indicating severe symptoms)
Comparison of Beverage Tolerability Questionnaire (BTQ): individual score and composite score between control and study products, and between both study products containing different doses of glycerol.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start16 Apr 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nora Schneider, Principal investigator, Nestlé Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981468
- Sponsor's protocol ID
- 2309NR
- Acronym
- H2O
- Status last verified
- Nov 2025
- First submitted
- 23 Apr 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H2O - Hydration to be Optimized With a Low-sodium Beverage
- ClinicalTrials.gov ID
- NCT06981468
- Acronym / sponsor ID
- H2O / 2309NR
- Conditions
- Hydration Status
- Keywords
- Hydration, Low-sodium beverage, H20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional Product 1 | Active comparator | Dietary Supplement: Low Sodium Beverage 1Glycerol (Dose 1) and Whey Protein |
| Interventional Product 2 | Active comparator | Dietary Supplement: Low Sodium Beverage 2Glycerol (Dose 2) and Whey Protein |
| Comparator | Placebo comparator | Other: Control (placebo) groupWater |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Sodium Beverage 1The 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. | Dietary supplement | Interventional Product 1 |
| Low Sodium Beverage 2The 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. | Dietary supplement | Interventional Product 2 |
| Control (placebo) groupWater | Other | Comparator |
Primary outcome
Fluid Retention (%) - fluid intake vs. urine output measurement
Time frame: 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)
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.
11 secondary outcomes
Fluid Retention (%) 1hr measure - fluid intake vs. urine output measurement
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Urine Specific Gravity (USG) - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730)
Time frame: 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)
Change in USG from baseline to 1 and 2 hours - measured in duplicate with a Digital Hand-Held Pen-Pro Refractometer (Atago 3730)
Time frame: 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)
Change in calculated serum osmolality - by Blood Microsampling with Tasso Device
Time frame: 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)
Hydration Questionnaire Part 1 - Visual Analogue Scale (VAS) Questionnaire (From 0-10cm, 0 indicating "not at all" and 10 indicating "extremely")
Time frame: 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).
Hydration Questionnaire Part 2 - Visual Analogue Scale (VAS) Questionnaire (Scale 0-10 cm, 0 indicating the worst score and 10 indicating the best score)
Time frame: 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).
Safety and Tolerability - Beverage Tolerability Questionnaire (Scale of 1-4, 1 indicating no symptoms and 4 indicating severe symptoms)
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Hydration Status
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Schneider principal investigator
Nestlé Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Sodium Beverage 1 and Low Sodium Beverage 2 in people with Hydration Status, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid Retention (%) - fluid intake vs. urine output measurement (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.