Effects of beverage ingredients on fluid balance in healthy adults
Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
This study tests how different ingredients in drinks, like sodium and glycerol, affect how well healthy adults keep fluids in their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | PepsiCo Global R&D Industry-sponsored |
| Locations | 3 sites (Bradenton, Florida and 2 other locations) |
| Trial ID | NCT06854471 on ClinicalTrials.gov |
What this trial studies
This study investigates how different concentrations of sodium and glycerol in beverages, along with varying fluid volumes, affect fluid retention in healthy, euhydrated men and women. Participants will consume various electrolyte solutions and a placebo beverage to assess their impact on overall fluid balance. The research aims to understand how these ingredients can enhance renal water reabsorption and minimize fluid loss through urination.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18-50 who are recreationally active and do not have any health conditions that could interfere with the study.
Not a fit: Patients with cardiovascular, renal, or metabolic diseases, or those taking medications that may interfere with fluid balance, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hydration strategies for athletes and individuals engaged in physical activities.
How similar studies have performed: Other studies have shown that electrolyte solutions can improve hydration, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * 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 Exclusion Criteria: * 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.
Where this trial is running
Bradenton, Florida and 2 other locations
- IMG Academy/GSSI Bradenton Gatorade Sports Science Institute — Bradenton, Florida, United States (Recruiting)
- GCP Research — St. Petersburg, Florida, United States (Recruiting)
- Gatorade Sports Science Institute — Valhalla, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Baker, PhD — PepsiCo R&D/Gatorade and Sports Science Institute
- Study coordinator: Lindsay Baker, PhD
- Email: Lindsay.Baker@pepsico.com
- Phone: 800.884.2867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.