Recruiting

Sodium & Glycerol

Sponsor:

PepsiCo Global R&D

Code:

NCT06854471

Conditions

Fluid Balance

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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.

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

Study ID

NCT06854471

Start date

Apr 9, 2025

Status verified date

Jul, 2025

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo beverage

Base beverage, no electrolytes, no glycerol

experimental: Electrolyte solution without glycerol beverage 1

Higher electrolytes lower volume

experimental: Electrolyte solution without glycerol beverage 2

Lower electrolytes mid-volume

experimental: Electrolyte solution without glycerol beverage 3

Higher electrolytes higher volume

experimental: Electrolyte solution with glycerol beverage 1

Lower electrolytes, lower glycerol, lower volume

experimental: Electrolyte solution with glycerol beverage 2

Higher electrolytes, higher glycerol, lower volume

experimental: Electrolyte solution with glycerol beverage 3

Higher electrolytes, higher glycerol, higher volume

experimental: Base with glycerol beverage 1

No electrolytes, higher glycerol, lower volume

experimental: Base with glycerol beverage 2

No electrolytes, lower glycerol, mid-volume

experimental: Base with glycerol beverage 3

No electrolytes, higher glycerol, higher volume

Interventions

Placebo beverage, kiwi-strawberry flavor

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 1

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 2

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 3

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 1

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 2

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 3

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 1

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 2

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 3

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.

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 ]

Central Contacts and Locations

Central contacts

Lindsay Baker, PhD

800.884.2867Lindsay.Baker@pepsico.com

Locations

IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

Recruiting

Bradenton, Florida, United States, 34210

Contacts

Kris Osterberg, PhD

941-201-3820kris.osterberg@pepsico.com

GCP Research

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Jessica Cruz, RN

727.520.1427jcruz@researchgcp.com

Madelaine Perez

727.520.1427mperez@researchgcp.com

Gatorade Sports Science Institute

Recruiting

Valhalla, New York, United States, 10595

Contacts

Lindsay Baker, PhD

814-883-9454

More Information

Sponsor

PepsiCo Global R&D

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • hydration
  • electrolytes
  • glycerol
  • beverage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by PepsiCo Global R&D on 2025-07-17.