RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink. In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.

Official Title

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

Quick Facts

Study Start:2024-10-07
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06654557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * If female, subject is not pregnant (based on self-report)
  2. * 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)
  3. * Subject does not smoke (or has quit for at least 6 months)
  4. * Subject is not taking medication that may interfere with the study (e.g., diuretics)
  5. * Subject has no health conditions that would interfere with the study, As indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases
  6. * Subject is not allergic to adhesives (e.g., medical tape)
  7. * Subject is not allergic to kiwi-strawberry flavoring
  8. * Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
  9. * Subject is willing to fast overnight (\~8-12 hours)
  10. * Subject is willing to refrain from vigorous exercise for 24 hours (light physical activity only)
  11. * Subject is willing to eat the exact same food the day prior to each visit to the laboratory
  12. * Able to speak, write, and read English
  13. * Provision of written consent to participate
  1. * Subject has participated in a clinical trial within the past 30 days
  2. * Subject has participated in any PepsiCo trial within past 6 months
  3. * 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
  4. * 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.

Contacts and Locations

Study Contact

Lindsay Baker, PhD
CONTACT
814-883-9454
Lindsay.Baker@pepsico.com

Principal Investigator

Lindsay Baker, PhD
PRINCIPAL_INVESTIGATOR
PepsiCo R&D Life Sciences, Sports Science

Study Locations (Sites)

PepsiCo R&D, Gatorade Sports Science Institute
Valhalla, New York, 10595
United States

Collaborators and Investigators

Sponsor: PepsiCo Global R&D

  • Lindsay Baker, PhD, PRINCIPAL_INVESTIGATOR, PepsiCo R&D Life Sciences, Sports Science

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-07
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-10-07
Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

  • hydration
  • electrolytes
  • glycerol
  • carbohtydrate
  • beverage

Additional Relevant MeSH Terms

  • Fluid Balance