Fluid BalanceNCT06654557
Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
A study testing 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only), 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) and 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) in people with Fluid Balance, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. 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?
- 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only), 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) and 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 23 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
- Subject is male or female
- If female, subject is not pregnant (based on self-report)
- 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)
- 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
Show all 14Show fewer
- Subject is not allergic to adhesives (e.g., medical tape)
- Subject is not allergic to kiwi-strawberry flavoring
- 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 (light physical activity only)
- 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 results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.
In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.
Read the detailed description
This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.
Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25
Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70
- Conditions
- Fluid Balance
- Being tested
- Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2), 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only), 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only), 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2), 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)
- Keywords
- hydration, electrolytes, glycerol, carbohtydrate, beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose.
0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)Other
9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) 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 (Parts 1 and 2) | Placebo comparator | Not described Receives: Other: Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2) |
| 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) | Experimental | Not described Receives: Other: 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) |
| 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) | Experimental | Not described Receives: Other: 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) |
| 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) | Experimental | Not described Receives: Other: 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) |
| 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) | Experimental | Not described Receives: Other: 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) |
| 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Experimental | Not described Receives: Other: 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) |
| 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Experimental | Not described Receives: Other: 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance (Body Weight)
Platform scale to the nearest 0.005 kilograms (kg)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Fluid balance (Percent (%) change in Body Mass)
Platform scale to the nearest 0.005 kilograms (kg)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Secondary outcomes (15)
Fluid retention
Platform scale to the nearest 0.005 kilograms (kg), unit percent (%)
Measured: % change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Urine mass
Graduated cylinder on scale to the nearest 0.01 grams
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Urine specific gravity
USG digital pen refractometer (Atago), no unit
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Blood sodium
Fingerstick sampling, unit millimoles per liter (mmol/L), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Blood glucose
Fingerstick sampling, unit milligrams per deciliter (mg/dl), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Percent change in plasma volume
Fingerstick sampling, calculated from hematocrit and hemoglobin concentration percent (%)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Serum glycerol concentration
Fingerstick sampling unit millimoles per liter (mmol/L) using Sigma Aldrich glycerol assay kit
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Serum osmolality
Fingerstick sampling, unit milliosmoles per kilogram of water (mOsm/Kg H20)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Saliva osmolality
Measured directly from the tongue using a handheld MX3 Diagnostics device, unit milliosmoles per kilogram of water (mOsm/kg H2O)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Blood pressure (systolic/diastolic)
Automatic sphygmomanometer unit millimeters of mercury (mm/Hg)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Heart rate
Heart rate monitor, unit beats per minute (bpm)
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Subjective measure of headache
One item on a 100 point visual analog scale anchored from 0=No headache to 100=Severe headache
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Subjective measure of lightheadedness
One item on a 100 point visual analog scale anchored from 0=No lightheadedness to 100=Severe lightheadedness
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Subjective measures of gastrointestinal discomfort
Eight items on a 100 point visual analog scale (stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea anchored frrom 0= None to 100=Severe
Measured: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Menstrual categorization
Using Elliott-Sale chart, 2023 to categorize menstrual/hormonal contraceptive status for those who have not yet reached perimenopause/menopause. This is a decision-tree chart, not a scale.
Measured: Assessed at Screening Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Sep 2024
- Primary completion23 Jun 2025
- Study completion23 Jun 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 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 Life Sciences, Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654557
- Sponsor's protocol ID
- PEP-2412
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2024
- Last updated
- 18 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
- ClinicalTrials.gov ID
- NCT06654557
- Acronym / sponsor ID
- PEP-2412
- Conditions
- Fluid Balance
- Keywords
- hydration, electrolytes, glycerol, carbohtydrate, beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 23 Oct 2024 (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 results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.
In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.
Detailed description
This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.
Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25
Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo beverage (Parts 1 and 2) | Placebo comparator | Other: Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2) |
| 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) | Experimental | Other: 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) |
| 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) | Experimental | Other: 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) |
| 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) | Experimental | Other: 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) |
| 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) | Experimental | Other: 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) |
| 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Experimental | Other: 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) |
| 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Experimental | Other: 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) |
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 (based on self-report)
- 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)
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 flavor (Part 1 and Part 2)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. | Other | Placebo beverage (Parts 1 and 2) |
| 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) |
| 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) |
| 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) |
| 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) |
| 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) |
| 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. | Other | 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) |
Primary outcome
Fluid balance (Body Weight)
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Platform scale to the nearest 0.005 kilograms (kg)
Fluid balance (Percent (%) change in Body Mass)
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Platform scale to the nearest 0.005 kilograms (kg)
15 secondary outcomes
Fluid retention
Time frame: % change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Urine mass
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Urine specific gravity
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Blood sodium
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Blood glucose
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Percent change in plasma volume
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Serum glycerol concentration
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Serum osmolality
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Saliva osmolality
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Blood pressure (systolic/diastolic)
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Heart rate
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Subjective measure of headache
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Subjective measure of lightheadedness
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Subjective measures of gastrointestinal discomfort
Time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage
Menstrual categorization
Time frame: Assessed at Screening Visit
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 18 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 Life Sciences, 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 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only), 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) and 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) 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 18 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 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 (Body Weight) (time frame: Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage). The study lists 2 primary outcomes in all. 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 18 Sep 2026.