Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID07217834

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

Led by PepsiCo Global R&D · Updated on 2025-10-20

30

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating how a glycerol-electrolyte beverage affects fluid balance in healthy men and women who are already properly hydrated. The study compares this beverage to a base drink without electrolytes or glycerol to understand its impact on fluid retention. The study is sponsored by PepsiCo Global R&D and focuses on healthy adults aged 18 to 50 who engage in regular physical activity. Participants receive either a placebo beverage or an experimental glycerol beverage, both kiwi-strawberry flavored, consumed as three equal portions totaling one liter over 30 minutes. The study uses a randomized design with four-way masking to compare these two drinks. The intervention period lasts about three weeks during which fluid balance and related measures are monitored. During the study, participants will undergo assessments including urine volume, urine concentration, hydration index, blood pressure, heart rate, and subjective symptoms like thirst and gastrointestinal discomfort. Female participants report menstrual status once at screening. Researchers will track adverse events throughout the study. Participants must follow specific preparation instructions such as fasting overnight and avoiding vigorous exercise and alcohol before visits. The total participation period spans approximately three weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 weeks

Participants receive either the placebo beverage or the experimental glycerol-electrolyte beverage in a crossover design, consuming 3 equal aliquots totaling 1 liter over a 30 minute period per session.

Multiple visits during the treatment period according to crossover schedule

Trial Site Locations

Total: 1 location

1

IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

Bradenton, Florida, United States, 34210

Actively Recruiting

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Research Team

L

Lindsay Baker, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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