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

NCT ID: NCT07217834

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-12-12

Brief Summary

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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

Detailed Description

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Conditions

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Fluid Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Beverage

Base beverage, no electrolytes, no glycerol

Group Type PLACEBO_COMPARATOR

Placebo beverage, kiwi-strawberry flavor

Intervention Type OTHER

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

Experimental Beverage

Glycerol beverage with electrolytes

Group Type EXPERIMENTAL

Experimental glycerol beverage, kiwi-strawberry flavor

Intervention Type OTHER

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

Interventions

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Placebo beverage, kiwi-strawberry flavor

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

Intervention Type OTHER

Experimental glycerol beverage, kiwi-strawberry flavor

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

Intervention Type OTHER

Eligibility Criteria

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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, 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lindsay Baker

Role: PRINCIPAL_INVESTIGATOR

PepsiCo R&D/Gatorade and Sports Science Institute

Locations

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IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

Bradenton, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lindsay Baker, PhD

Role: CONTACT

800.884.2867

Facility Contacts

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Role: primary

8008842867

Role: backup

Other Identifiers

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PEP-2511

Identifier Type: -

Identifier Source: org_study_id

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