Fluid BalanceNCT06854471
Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
A study testing Electrolyte solution without glycerol beverage 1, Electrolyte solution without glycerol beverage 2 and Electrolyte solution without glycerol beverage 3 in people with Fluid Balance, run by PepsiCo Global R&D at 3 sites in United States.
Trial summary
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination. 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?
- Electrolyte solution without glycerol beverage 1, Electrolyte solution without glycerol beverage 2 and Electrolyte solution without glycerol beverage 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jul 2025to 2 Dec 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)
Show all 12Show fewer
- Subject has no health conditions that would interfere with the study (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
- 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
3 sites in 1 country.
United States3 sites
IMG Academy/GSSI Bradenton Gatorade Sports Science Institute
Bradenton, Florida, 34210
GCP Research
St. Petersburg, Florida, 33705
Gatorade Sports Science Institute
Valhalla, New York, 10595
About this study
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.
The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.
- Conditions
- Fluid Balance
- Being tested
- Placebo beverage, kiwi-strawberry flavor, Electrolyte solution without glycerol beverage 1, Electrolyte solution without glycerol beverage 2, Electrolyte solution without glycerol beverage 3, Electrolyte solution with glycerol beverage 1
- 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
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose
Electrolyte solution without glycerol beverage 1Other
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Electrolyte solution without glycerol beverage 2Other
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Electrolyte solution without glycerol beverage 3Other
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Electrolyte solution with glycerol beverage 1Other
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Electrolyte solution with glycerol beverage 2Other
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Electrolyte solution with glycerol beverage 3Other
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Base with glycerol, no electrolytes beverage 1Other
4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Base with glycerol, no electrolytes beverage 2Other
6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Base with glycerol, no electrolytes beverage 3Other
9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
| Study group | Role | What they receive |
|---|---|---|
| Placebo beverage | Placebo comparator | Base beverage, no electrolytes, no glycerol Receives: Other: Placebo beverage, kiwi-strawberry flavor |
| Electrolyte solution without glycerol beverage 1 | Experimental | Higher electrolytes lower volume Receives: Other: Electrolyte solution without glycerol beverage 1 |
| Electrolyte solution without glycerol beverage 2 | Experimental | Lower electrolytes mid-volume Receives: Other: Electrolyte solution without glycerol beverage 2 |
| Electrolyte solution without glycerol beverage 3 | Experimental | Higher electrolytes higher volume Receives: Other: Electrolyte solution without glycerol beverage 3 |
| Electrolyte solution with glycerol beverage 1 | Experimental | Lower electrolytes, lower glycerol, lower volume Receives: Other: Electrolyte solution with glycerol beverage 1 |
| Electrolyte solution with glycerol beverage 2 | Experimental | Higher electrolytes, higher glycerol, lower volume Receives: Other: Electrolyte solution with glycerol beverage 2 |
| Electrolyte solution with glycerol beverage 3 | Experimental | Higher electrolytes, higher glycerol, higher volume Receives: Other: Electrolyte solution with glycerol beverage 3 |
| Base with glycerol beverage 1 | Experimental | No electrolytes, higher glycerol, lower volume Receives: Other: Base with glycerol, no electrolytes beverage 1 |
| Base with glycerol beverage 2 | Experimental | No electrolytes, lower glycerol, mid-volume Receives: Other: Base with glycerol, no electrolytes beverage 2 |
| Base with glycerol beverage 3 | Experimental | No electrolytes, higher glycerol, higher volume Receives: Other: Base with glycerol, no electrolytes beverage 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance
Calculated as change in body mass kg and %
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Secondary outcomes (17)
Urine mass
(g)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Urine specific gravity
(au)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Urine osmolality
(mosmol/kg)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Whole blood hematocrit
(%)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Whole blood hemoglobin concentration
(g/dl)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum sodium concentration
(mmol/L)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum potassium concentration
(mmol/L)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum chloride concentration (mmol/L)
(mmol/L)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum glucose concentration
(mg/dl)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum glycerol concentration
(mmol/L)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum copeptin concentration
(pmol/L)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum osmolality
(mosmol/kg)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Blood pressure
(systolic/diastolic) (mmHg)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Heart rate
(bpm)
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Subjective measures of gastrointestinal discomfort and headache (VAS)
Rated on a 100 point scale from none to severe for headache, lightheaded, stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea).
Measured: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Menstrual categorization
Current status (e.g., contraception, regular periods or not, etc.)
Measured: Screening visit
Adverse Events
Documented changes in health and symptoms
Measured: From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start18 Jul 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 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
- 60 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 R&D/Gatorade and Sports Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854471
- Sponsor's protocol ID
- PEP-2420
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2025
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
- ClinicalTrials.gov ID
- NCT06854471
- Acronym / sponsor ID
- PEP-2420
- Conditions
- Fluid Balance
- Keywords
- hydration, electrolytes, glycerol, beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 3 Mar 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.
The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.
The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes 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
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo beverage | Placebo comparator | Other: Placebo beverage, kiwi-strawberry flavorBase beverage, no electrolytes, no glycerol |
| Electrolyte solution without glycerol beverage 1 | Experimental | Other: Electrolyte solution without glycerol beverage 1Higher electrolytes lower volume |
| Electrolyte solution without glycerol beverage 2 | Experimental | Other: Electrolyte solution without glycerol beverage 2Lower electrolytes mid-volume |
| Electrolyte solution without glycerol beverage 3 | Experimental | Other: Electrolyte solution without glycerol beverage 3Higher electrolytes higher volume |
| Electrolyte solution with glycerol beverage 1 | Experimental | Other: Electrolyte solution with glycerol beverage 1Lower electrolytes, lower glycerol, lower volume |
| Electrolyte solution with glycerol beverage 2 | Experimental | Other: Electrolyte solution with glycerol beverage 2Higher electrolytes, higher glycerol, lower volume |
| Electrolyte solution with glycerol beverage 3 | Experimental | Other: Electrolyte solution with glycerol beverage 3Higher electrolytes, higher glycerol, higher volume |
| Base with glycerol beverage 1 | Experimental | Other: Base with glycerol, no electrolytes beverage 1No electrolytes, higher glycerol, lower volume |
| Base with glycerol beverage 2 | Experimental | Other: Base with glycerol, no electrolytes beverage 2No electrolytes, lower glycerol, mid-volume |
| Base with glycerol beverage 3 | Experimental | Other: Base with glycerol, no electrolytes beverage 3No electrolytes, higher glycerol, higher volume |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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 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 |
|---|---|---|
| Placebo beverage, kiwi-strawberry flavor9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose | Other | Placebo beverage |
| Electrolyte solution without glycerol beverage 14 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Electrolyte solution without glycerol beverage 1 |
| Electrolyte solution without glycerol beverage 26.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Electrolyte solution without glycerol beverage 2 |
| Electrolyte solution without glycerol beverage 39.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Electrolyte solution without glycerol beverage 3 |
| Electrolyte solution with glycerol beverage 14 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Electrolyte solution with glycerol beverage 1 |
| Electrolyte solution with glycerol beverage 24 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Electrolyte solution with glycerol beverage 2 |
| Electrolyte solution with glycerol beverage 39.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Electrolyte solution with glycerol beverage 3 |
| Base with glycerol, no electrolytes beverage 14 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Base with glycerol beverage 1 |
| Base with glycerol, no electrolytes beverage 26.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Base with glycerol beverage 2 |
| Base with glycerol, no electrolytes beverage 39.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | Base with glycerol beverage 3 |
Primary outcome
Fluid balance
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Calculated as change in body mass kg and %
17 secondary outcomes
Urine mass
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Urine specific gravity
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Urine osmolality
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Whole blood hematocrit
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Whole blood hemoglobin concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum sodium concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum potassium concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum chloride concentration (mmol/L)
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum glucose concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum glycerol concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum copeptin concentration
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Serum osmolality
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes
Blood pressure
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Heart rate
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Subjective measures of gastrointestinal discomfort and headache (VAS)
Time frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes
Menstrual categorization
Time frame: Screening visit
Adverse Events
Time frame: From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6)
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 21 Sep 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, PhD principal investigator
PepsiCo R&D/Gatorade and Sports Science Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrolyte solution without glycerol beverage 1, Electrolyte solution without glycerol beverage 2 and Electrolyte solution without glycerol beverage 3 in people with Fluid Balance, run by PepsiCo Global R&D at 3 sites 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 12 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 30, 60, 90,120, 150,180 and 210 minutes). 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 21 Sep 2026.