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 — OTHER
    9.3.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 — OTHER
    4 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 — OTHER
    6.7 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 — OTHER
    9.3.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 — OTHER
    4 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 — OTHER
    4 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 — OTHER
    9.3.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 — OTHER
    4 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 — OTHER
    6.7 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 — OTHER
    9.3.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 beverage
    Base beverage, no electrolytes, no glycerol
  • Experimental: Electrolyte solution without glycerol beverage 1
    Higher electrolytes lower volume
  • Experimental: Electrolyte solution without glycerol beverage 2
    Lower electrolytes mid-volume
  • Experimental: Electrolyte solution without glycerol beverage 3
    Higher electrolytes higher volume
  • Experimental: Electrolyte solution with glycerol beverage 1
    Lower electrolytes, lower glycerol, lower volume
  • Experimental: Electrolyte solution with glycerol beverage 2
    Higher electrolytes, higher glycerol, lower volume
  • Experimental: Electrolyte solution with glycerol beverage 3
    Higher electrolytes, higher glycerol, higher volume
  • Experimental: Base with glycerol beverage 1
    No electrolytes, higher glycerol, lower volume
  • Experimental: Base with glycerol beverage 2
    No electrolytes, lower glycerol, mid-volume
  • Experimental: Base with glycerol beverage 3
    No 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

Locations (3)

FacilityCityStateZIPSite coordinators
IMG Academy/GSSI Bradenton Gatorade Sports Science InstituteBradentonFlorida34210
Kris Osterberg, PhD
941-201-3820
GCP ResearchSt. PetersburgFlorida33705
Jessica Cruz, RN
727.520.1427
Madelaine Perez
727.520.1427
Gatorade Sports Science InstituteValhallaNew York10595
Lindsay Baker, PhD
814-883-9454

Find similar trials in Bradenton, FL

Related Studies