HydrationNCT06185595
Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
A study testing Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. in people with Hydration, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 28 Jun 2024
- 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
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- You are at least recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
- Subject does not smoke (or has quit for at least 6 months)
- Subject is not taking medication that may interfere with the study (e.g., diuretics)
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- Subject has no health conditions that would interfere with the study as indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases
- Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
- Subject is willing to fast overnight (~8-12 hours)
- Subject is willing to refrain from vigorous exercise for 24 hours
- Subject is willing to eat the exact same food the day prior to each visit to the laboratory
- Able to speak, write, and read English
- Provision of written consent to participate
Who cannot join
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 6 months
- Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
- Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
PepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, 10595
About this study
The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.
- Conditions
- Hydration
- Being tested
- Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.
- Keywords
- hydration, euhydration, fluid balance, fluid retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.Other
9.3 oz (273 ml) aliquot of one of the study beverages every 15 min for a total of 28 oz (828 ml) over a 45-min period, followed by 15 min of rest. Flavored water matched for sweetness, color. flavor, but cannot be matched for saltiness. All sodium-containing drinks will include a base blend of other electrolytes (potassium 15 mmol/L, magnesium 8 mmol/L, and calcium 5 mmol/L).
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No sodium, No glycerol Receives: Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. |
| Sodium only group 1 | Experimental | 55 mmol/L sodium Receives: Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. |
| Glycerol only | Experimental | 4.6% glycerol Receives: Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. |
| Sodium and Glycerol group 1 | Experimental | 55 mmol/L sodium and 4.6% glycerol Receives: Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. |
| Sodium only group 2 | Experimental | 27.5 mmol/L sodium Receives: Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. |
| Sodium and Glycerol group 2 | Experimental | 27.5 mmol/L sodium and 2.3% glycerol Receives: Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance
Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Secondary outcomes (12)
Fluid retention
As a percent (%)
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Urine mass
By urine mass scale in grams (g)
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Urine specific gravity
By USG digital pen refractometer
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Blood sodium
By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mmol/L
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Blood glucose
Glucometer for point of care test in mg/dL
Measured: Screening visit only
Blood glucose
By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mg/dL
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Percent change in plasma volume
Calculated from hematocrit and hemoglobin concentration
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Serum glycerol concentration
By Sigma Aldrich glycerol assay kit in mmol/L
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Blood pressure
mmHg by automatic sphygmomanometer
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Heart rate
Beats per minute (bpm) by heart rate monitor
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Subjective measures of gastrointestinal discomfort and headache
Visual Analog Scale (VAS) symptom rating of how you feel right now by placing a slash along a 100 millimeter (mm) vertical line anchored from 0 mm (None) to 100 mm (Severe). Fewer symptoms and lower numbers are better.
Measured: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Menstrual cycle phase
Date of last menstrual period by self-report of female participant
Measured: Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start8 Jan 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HydrationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsay Baker, PhD, Principal investigator, PepsiCo, Inc. Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185595
- Sponsor's protocol ID
- PEP-2311
- Status last verified
- Jan 2025
- First submitted
- 8 Dec 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker LB, Hinkley JM, Ozga M, Alfred SL, Merritt JR, De Chavez PJD. A randomized trial modeling the effects of solutions with low to moderate glycerol and sodium concentrations on fluid balance in healthy, active adults. Am J Clin Nutr. 2026 Jan;123(1):101094. doi: 10.1016/j.ajcnut.2025.10.011. Epub 2025 Oct 23.
PubMed 41138915
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
- ClinicalTrials.gov ID
- NCT06185595
- Acronym / sponsor ID
- PEP-2311
- Conditions
- Hydration
- Keywords
- hydration, euhydration, fluid balance, fluid retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 29 Dec 2023 (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.
The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.No sodium, No glycerol |
| Sodium only group 1 | Experimental | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.55 mmol/L sodium |
| Glycerol only | Experimental | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.4.6% glycerol |
| Sodium and Glycerol group 1 | Experimental | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.55 mmol/L sodium and 4.6% glycerol |
| Sodium only group 2 | Experimental | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.27.5 mmol/L sodium |
| Sodium and Glycerol group 2 | Experimental | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.27.5 mmol/L sodium and 2.3% glycerol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- You are at least recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
- Subject does not smoke (or has quit for at least 6 months)
Key exclusion criteria (4 listed)
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 6 months
- Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
- Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
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 |
|---|---|---|
| Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.9.3 oz (273 ml) aliquot of one of the study beverages every 15 min for a total of 28 oz (828 ml) over a 45-min period, followed by 15 min of rest. Flavored water matched for sweetness, color. flavor, but cannot be matched for saltiness. All sodium-containing drinks will include a base blend of other electrolytes (potassium 15 mmol/L, magnesium 8 mmol/L, and calcium 5 mmol/L). | Other | Control, Glycerol only, Sodium and Glycerol group 1, Sodium and Glycerol group 2, Sodium only group 1, Sodium only group 2 |
Primary outcome
Fluid balance
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale
12 secondary outcomes
Fluid retention
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Urine mass
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Urine specific gravity
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Blood sodium
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Blood glucose
Time frame: Screening visit only
Blood glucose
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Percent change in plasma volume
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Serum glycerol concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Blood pressure
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Heart rate
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Subjective measures of gastrointestinal discomfort and headache
Time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Menstrual cycle phase
Time frame: Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.
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 3 Jan 2025.
- Derived from this study: PubMed 41138915Baker LB, Hinkley JM, Ozga M, Alfred SL, Merritt JR, De Chavez PJD. A randomized trial modeling the effects of solutions with low to moderate glycerol and sodium concentrations on fluid balance in healthy, active adults. Am J Clin Nutr. 2026 Jan;123(1):101094. doi: 10.1016/j.ajcnut.2025.10.011. Epub 2025 Oct 23.
- Individual participant dataSharing planned: No
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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.
Lindsay Baker, PhD principal investigator
PepsiCo, Inc. Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. in people with Hydration, run by PepsiCo Global R&D at 1 site in United States.
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 13 inclusion and 4 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 3 Jan 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 United States. 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 balance (time frame: Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185595, which also lists 1 linked publication.
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 3 Jan 2025.