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OpenTrials
Completed

NCT Number: NCT07217834

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

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

Bradenton, Florida, 34210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo beverage, kiwi-strawberry flavor

Other

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

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.

Primary outcomes

  1. Fluid balance

    Time frame: Through study completion, average of 3 weeks

    Calculated as change in nude body mass, %

Secondary outcomes

  1. Fluid Balance

    Time frame: Through study completion, average of 3 weeks

    Calculated as change in nude body mass, kg

  2. Urine Mass

    Time frame: Through study completion, average of 3 weeks

    (g)

  3. Beverage Hydration Index

    Time frame: Through study completion, average of 3 weeks

    calculated as the cumulative urine mass after drinking the placebo divided by the cumulative urine mass after drinking the test beverage

  4. Urine specific gravity

    Time frame: Through study completion, average of 3 weeks

    (au)

  5. Blood Pressure

    Time frame: Through study completion, average of 3 weeks

    systolic/diastolic (mmHg)

  6. Heart Rate

    Time frame: Through study completion, average of 3 weeks

    bpm

  7. Subjective measures of thirst, gastrointestinal discomfort, lightheadedness and headache

    Time frame: Through study completion, average of 3 weeks

    Rated on a 100-pt scale from none to extreme/severe for headache, lightheaded, stomach upset, nausea, abdominal discomfort, stomach fullness, thirsty, and hydrated.

  8. Menstrual categorization

    Time frame: Reported by female subjects one time at screening visit.

    Menstrual categorization chart (Elliott-Sale, 2023). Current status (e.g., contraception, regular periods or not, etc.).

  9. Adverse Events

    Time frame: Through study completion, average of 3 weeks.

    Documented changes in health and symptoms. Documented both in clinic and between visits in a provided paper log reviewed at each visit

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 20, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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