| Registry | NCT06854471 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: quadruple, other |
| Enrollment | 60 (Actual) |
| Sponsor | PepsiCo Global R&D (Industry) |
| Conditions | Fluid Balance |
| Interventions | Placebo beverage, kiwi-strawberry flavor, Electrolyte solution without glycerol beverage 1, Electrolyte solution without glycerol beverage 2, Electrolyte solution without glycerol beverage 3, Electrolyte solution with glycerol beverage 1, Electrolyte solution with glycerol beverage 2, Electrolyte solution with glycerol beverage 3, Base with glycerol, no electrolytes beverage 1, Base with glycerol, no electrolytes beverage 2, Base with glycerol, no electrolytes beverage 3 (Other) |
| Dates | start 2025-07-18, primary completion 2025-12-02, completion 2025-12-02, first posted 2025-03-03, last updated 2026-09-21 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Fluid Balance All trials of Placebo beverage, kiwi-strawberry flavor All trials of Electrolyte solution without glycerol beverage 1
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo beverage | Placebo comparator | Other: Placebo beverage, kiwi-strawberry flavor | Base beverage, no electrolytes, no glycerol |
| Electrolyte solution without glycerol beverage 1 | Experimental | Other: Electrolyte solution without glycerol beverage 1 | Higher electrolytes lower volume |
| Electrolyte solution without glycerol beverage 2 | Experimental | Other: Electrolyte solution without glycerol beverage 2 | Lower electrolytes mid-volume |
| Electrolyte solution without glycerol beverage 3 | Experimental | Other: Electrolyte solution without glycerol beverage 3 | Higher electrolytes higher volume |
| Electrolyte solution with glycerol beverage 1 | Experimental | Other: Electrolyte solution with glycerol beverage 1 | Lower electrolytes, lower glycerol, lower volume |
| Electrolyte solution with glycerol beverage 2 | Experimental | Other: Electrolyte solution with glycerol beverage 2 | Higher electrolytes, higher glycerol, lower volume |
| Electrolyte solution with glycerol beverage 3 | Experimental | Other: Electrolyte solution with glycerol beverage 3 | Higher electrolytes, higher glycerol, higher volume |
| Base with glycerol beverage 1 | Experimental | Other: Base with glycerol, no electrolytes beverage 1 | No electrolytes, higher glycerol, lower volume |
| Base with glycerol beverage 2 | Experimental | Other: Base with glycerol, no electrolytes beverage 2 | No electrolytes, lower glycerol, mid-volume |
| Base with glycerol beverage 3 | Experimental | Other: Base with glycerol, no electrolytes beverage 3 | No electrolytes, higher glycerol, higher volume |
Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| IMG Academy/GSSI Bradenton Gatorade Sports Science Institute | Bradenton, Florida | United States | |
| GCP Research | St. Petersburg, Florida | United States | |
| Gatorade Sports Science Institute | Valhalla, New York | United States |