Fluid BalanceNCT07217834
Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women
A study testing Experimental glycerol beverage, kiwi-strawberry flavor in people with Fluid Balance, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy euhydrated men and women Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluid Balance
- What is being tested?
- Experimental glycerol beverage, kiwi-strawberry flavor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Nov 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
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- Subject is 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, laxatives, weight loss drugs)
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- Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
- Subject is not allergic to fuji apple pear flavoring
- Subject is not allergic to Stevia
- Subject is willing to avoid alcohol consumption 24 hours prior to visits
- Subject is willing to fast overnight (~8-10 hours) prior to visits
- 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 study session.
- Willing and able to provide signed informed consent to participate in the study and to comply with all study procedures and scheduled visits.
Who cannot join
- Subject has participated in a clinical trial within the past 30 days
- Subject has participated in any PepsiCo trial within past 3 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
IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
Bradenton, Florida, 34210
About this study
Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy euhydrated men and women
- Conditions
- Fluid Balance
- Being tested
- Placebo beverage, kiwi-strawberry flavor, Experimental glycerol beverage, kiwi-strawberry flavor
- Keywords
- hydration, electrolytes, glycerol, beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo beverage, kiwi-strawberry flavorOther
3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.
Experimental glycerol beverage, kiwi-strawberry flavorOther
3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Beverage | Placebo comparator | Base beverage, no electrolytes, no glycerol Receives: Other: Placebo beverage, kiwi-strawberry flavor |
| Experimental Beverage | Experimental | Glycerol beverage with electrolytes Receives: Other: Experimental glycerol beverage, kiwi-strawberry flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance
Calculated as change in nude body mass, %
Measured: Through study completion, average of 3 weeks
Secondary outcomes (9)
Fluid Balance
Calculated as change in nude body mass, kg
Measured: Through study completion, average of 3 weeks
Urine Mass
(g)
Measured: Through study completion, average of 3 weeks
Beverage Hydration Index
calculated as the cumulative urine mass after drinking the placebo divided by the cumulative urine mass after drinking the test beverage
Measured: Through study completion, average of 3 weeks
Urine specific gravity
(au)
Measured: Through study completion, average of 3 weeks
Blood Pressure
systolic/diastolic (mmHg)
Measured: Through study completion, average of 3 weeks
Heart Rate
bpm
Measured: Through study completion, average of 3 weeks
Subjective measures of thirst, gastrointestinal discomfort, lightheadedness and headache
Rated on a 100-pt scale from none to extreme/severe for headache, lightheaded, stomach upset, nausea, abdominal discomfort, stomach fullness, thirsty, and hydrated.
Measured: Through study completion, average of 3 weeks
Menstrual categorization
Menstrual categorization chart (Elliott-Sale, 2023). Current status (e.g., contraception, regular periods or not, etc.).
Measured: Reported by female subjects one time at screening visit.
Adverse Events
Documented changes in health and symptoms. Documented both in clinic and between visits in a provided paper log reviewed at each visit
Measured: Through study completion, average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start1 Oct 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid BalanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsay Baker, Principal investigator, PepsiCo R&D/Gatorade and Sports Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217834
- Sponsor's protocol ID
- PEP-2511
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women
- ClinicalTrials.gov ID
- NCT07217834
- Acronym / sponsor ID
- PEP-2511
- Conditions
- Fluid Balance
- Keywords
- hydration, electrolytes, glycerol, beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 20 Oct 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.
Glycerol and sodium are osmotically-active ingredients that promote fluid retention via renal water reabsorption. The purpose of this study is to compare the effects of a glycerol-electrolyte beverage on fluid balance in healthy euhydrated men and women
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Beverage | Placebo comparator | Other: Placebo beverage, kiwi-strawberry flavorBase beverage, no electrolytes, no glycerol |
| Experimental Beverage | Experimental | Other: Experimental glycerol beverage, kiwi-strawberry flavorGlycerol beverage with electrolytes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Subject is male or female
- If female, subject is not pregnant
- Subject is 18-50 years of age, inclusive
- Subject is 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 3 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 |
|---|---|---|
| Placebo beverage, kiwi-strawberry flavor3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed. | Other | Placebo Beverage |
| Experimental glycerol beverage, kiwi-strawberry flavor3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed. | Other | Experimental Beverage |
Primary outcome
Fluid balance
Time frame: Through study completion, average of 3 weeks
Calculated as change in nude body mass, %
9 secondary outcomes
Fluid Balance
Time frame: Through study completion, average of 3 weeks
Urine Mass
Time frame: Through study completion, average of 3 weeks
Beverage Hydration Index
Time frame: Through study completion, average of 3 weeks
Urine specific gravity
Time frame: Through study completion, average of 3 weeks
Blood Pressure
Time frame: Through study completion, average of 3 weeks
Heart Rate
Time frame: Through study completion, average of 3 weeks
Subjective measures of thirst, gastrointestinal discomfort, lightheadedness and headache
Time frame: Through study completion, average of 3 weeks
Menstrual categorization
Time frame: Reported by female subjects one time at screening visit.
Adverse Events
Time frame: Through study completion, average of 3 weeks.
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 15 Jul 2026.
- 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 principal investigator
PepsiCo R&D/Gatorade and Sports Science Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental glycerol beverage, kiwi-strawberry flavor in people with Fluid Balance, 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 14 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 15 Jul 2026. 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: Through study completion, average of 3 weeks). 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 15 Jul 2026.