Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Part of paid clinical trials in Bradenton, Florida.
- Sponsor
- PepsiCo Global R&D
- Study ID
- NCT06854471
- Status
- Recruiting
Conditions
- Fluid Balance
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Accepted
Interventions
- Placebo beverage, kiwi-strawberry flavor — OTHER9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose
- Electrolyte solution without glycerol beverage 1 — OTHER4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Electrolyte solution without glycerol beverage 2 — OTHER6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Electrolyte solution without glycerol beverage 3 — OTHER9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Electrolyte solution with glycerol beverage 1 — OTHER4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Electrolyte solution with glycerol beverage 2 — OTHER4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Electrolyte solution with glycerol beverage 3 — OTHER9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Base with glycerol, no electrolytes beverage 1 — OTHER4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Base with glycerol, no electrolytes beverage 2 — OTHER6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
- Base with glycerol, no electrolytes beverage 3 — OTHER9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.
Study Details
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.
Key Dates
- Start date
- Apr 9, 2025
- Status verified
- Jul 2025
- Primary completion
- Dec 15, 2025
- Completion
- Dec 15, 2025
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Placebo Comparator: Placebo beverageBase beverage, no electrolytes, no glycerol
- Experimental: Electrolyte solution without glycerol beverage 1Higher electrolytes lower volume
- Experimental: Electrolyte solution without glycerol beverage 2Lower electrolytes mid-volume
- Experimental: Electrolyte solution without glycerol beverage 3Higher electrolytes higher volume
- Experimental: Electrolyte solution with glycerol beverage 1Lower electrolytes, lower glycerol, lower volume
- Experimental: Electrolyte solution with glycerol beverage 2Higher electrolytes, higher glycerol, lower volume
- Experimental: Electrolyte solution with glycerol beverage 3Higher electrolytes, higher glycerol, higher volume
- Experimental: Base with glycerol beverage 1No electrolytes, higher glycerol, lower volume
- Experimental: Base with glycerol beverage 2No electrolytes, lower glycerol, mid-volume
- Experimental: Base with glycerol beverage 3No electrolytes, higher glycerol, higher volume
Primary Outcome Measure
Fluid balance [ Time Frame: Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes ]
Central Contacts
- Lindsay Baker, PhD800.884.2867
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| IMG Academy/GSSI Bradenton Gatorade Sports Science Institute | Bradenton | Florida | 34210 | |
| GCP Research | St. Petersburg | Florida | 33705 | |
| Gatorade Sports Science Institute | Valhalla | New York | 10595 | Lindsay Baker, PhD 814-883-9454 |
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