Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06654557

Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Led by PepsiCo Global R&D · Updated on 2025-02-11

95

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of adding glycerol to electrolyte beverages on fluid balance in healthy men and women who are well hydrated and at rest. This study follows earlier research suggesting that glycerol combined with sodium can improve fluid retention and balance. The study aims to test if fluid balance is maintained and greater than placebo after drinking carbohydrate-electrolyte beverages with varying glycerol content. The study has two parts where participants consume different carbohydrate-electrolyte drinks with and without glycerol or a placebo beverage. Each beverage is given in three doses of 9.3 oz (276 ml) over 35 minutes, followed by a rest period before measuring outcomes. Participants may take part in both parts of the study with dosing days spaced 2 to 15 days apart. Beverages are matched for color and flavor to maintain consistency. Participants will undergo multiple assessments including body weight and percent change in body mass before and after beverage consumption at several time points up to 150 minutes post-dose. Additional tests include measuring fluid retention, urine output, blood sodium and glucose levels, plasma volume changes, blood pressure, heart rate, and subjective symptoms like headache or lightheadedness. Menstrual status is also recorded at screening. The study involves careful monitoring and data collection to understand fluid balance effects over time.

CONDITIONS

Brief Title

Effect of Adding Glycerol to Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Females must not be pregnant (based on self-report)
  • Age between 18 and 50 years, inclusive
  • Recreationally active: engaged in light to moderate intensity exercise at least 3 days per week for at least 30 minutes
  • Non-smoker or quit smoking at least 6 months ago
  • Not taking medications that may interfere with the study (e.g., diuretics)
  • No health conditions interfering with study participation (such as cardiovascular, renal, or metabolic diseases)
  • No allergy to adhesives (e.g., medical tape)
  • No allergy to kiwi-strawberry flavoring
  • Willing to avoid alcohol 24 hours before visits
  • Willing to fast overnight (~8-12 hours) before visits
  • Willing to avoid vigorous exercise for 24 hours before visits
  • Willing to eat the same food the day before each visit
  • Able to speak, write, and read English
  • Provide written consent to participate
Not Eligible

You will not qualify if you...

  • Participated in any clinical trial within the past 30 days
  • Participated in any PepsiCo trial within the past 6 months
  • Conditions or medications that impair ability to consent, comply, or affect study results or increase risk
  • Employment or immediate family employment with companies competing with Gatorade, unless disclosed to investigators

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 screening and enrollment visit

Treatment

Duration - Variable, depending on number of dosing days and 2 to 15 days between dosing days

Participants complete either Part 1 or Part 2 of the study, consuming different carbohydrate electrolyte beverages or placebo on dosing days separated by 2 to 15 days. Each dosing day involves intake of beverages over approximately 1 hour followed by rest and assessments.

Multiple visits for beverage dosing and assessment, each lasting several hours

Trial Site Locations

Total: 1 location

1

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, United States, 10595

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

BASIC_SCIENCE

Number of Arms

7

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