RECRUITING

Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Conditions

Fluid Balance hydration electrolytes glycerol beverage

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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 presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination. The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.

Official Title

Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest

Quick Facts

Study Start:2025-02-21

Study Completion:2025-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06854471

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 Criteria	Exclusion 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) * Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases) * Subject is willing to avoid alcohol consumption 24 hours prior to visit(s) * Subject is willing to fast overnight (\~8-12 hours) * 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 visit to the laboratory * Provision of written consent to participate	* Subject has participated in a clinical trial within the past 30 days * Subject has participated in any PepsiCo trial within past 6 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.

Inclusion Criteria

Exclusion 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)
* Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
* Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
* Subject is willing to fast overnight (\~8-12 hours)
* 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 visit to the laboratory
* Provision of written consent to participate

* Subject has participated in a clinical trial within the past 30 days
* Subject has participated in any PepsiCo trial within past 6 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.

Contacts and Locations

Study Contact

Lindsay Baker, PhD

CONTACT

800.884.2867

Lindsay.Baker@pepsico.com

Principal Investigator

Lawrence Galitz, MD

PRINCIPAL_INVESTIGATOR

GCP Research

Study Locations (Sites)

GCP Research

Saint Petersburg, Florida, 33705

United States

Collaborators and Investigators

Sponsor: PepsiCo Global R&D

Lawrence Galitz, MD, PRINCIPAL_INVESTIGATOR, GCP Research

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 Date2025-02-21

Study Completion Date2025-12-15

Study Record Updates

Study Start Date2025-02-21

Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

hydration
electrolytes
glycerol
beverage

Additional Relevant MeSH Terms

Fluid Balance