Effects of a Glycerol-Electrolyte Beverage on Fluid Balance in Healthy Euhydrated Men and Women

NCT07217834 | Recruiting

• 1 other identifier: PEP-2511
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fluid Balance

Keywords

hydration; electrolytes; glycerol; beverage

Outcome Measures

Primary Outcomes (1)

• Fluid balance

  Calculated as change in nude body mass, %

  Through study completion, average of 3 weeks

Secondary Outcomes (9)

• Fluid Balance

  Through study completion, average of 3 weeks

• Urine Mass

  Through study completion, average of 3 weeks

• Beverage Hydration Index

  Through study completion, average of 3 weeks

• Urine specific gravity

  Through study completion, average of 3 weeks

• Blood Pressure

  Through study completion, average of 3 weeks

Study Arms (2)

Placebo Beverage

PLACEBO COMPARATOR

Base beverage, no electrolytes, no glycerol

Other: Placebo beverage, kiwi-strawberry flavor

Experimental Beverage

EXPERIMENTAL

Glycerol beverage with electrolytes

Other: Experimental glycerol beverage, kiwi-strawberry flavor

Interventions

Placebo beverage, kiwi-strawberry flavor OTHER

3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.

Placebo Beverage

Experimental glycerol beverage, kiwi-strawberry flavor OTHER

3 equal aliquots totaling 1 liter over a 30 min period, finishing each aliquot within 5 min followed.

Experimental Beverage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

Bradenton, Florida, 34210, United States

RECRUITING

Study Officials

• Lindsay Baker

  PepsiCo R&D/Gatorade and Sports Science Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Baker, PhD

CONTACT

800.884.2867; Lindsay.Baker@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 20, 2025
• Study Start: October 1, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)