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

NCT06854471 | Recruiting

• 1 other identifier: PEP-2420
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Fluid Balance

Keywords

hydration; electrolytes; glycerol; beverage

Outcome Measures

Primary Outcomes (1)

• Fluid balance

  Calculated as change in body mass kg and %

  Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes

Secondary Outcomes (17)

• Urine mass

  Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes

• Urine specific gravity

  Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes

• Urine osmolality

  Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes

• Whole blood hematocrit

  Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes

• Whole blood hemoglobin concentration

  Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes

Study Arms (10)

Placebo beverage

PLACEBO COMPARATOR

Base beverage, no electrolytes, no glycerol

Other: Placebo beverage, kiwi-strawberry flavor

Electrolyte solution without glycerol beverage 1

EXPERIMENTAL

Higher electrolytes lower volume

Other: Electrolyte solution without glycerol beverage 1

Electrolyte solution without glycerol beverage 2

EXPERIMENTAL

Lower electrolytes mid-volume

Other: Electrolyte solution without glycerol beverage 2

Electrolyte solution without glycerol beverage 3

EXPERIMENTAL

Higher electrolytes higher volume

Other: Electrolyte solution without glycerol beverage 3

Electrolyte solution with glycerol beverage 1

EXPERIMENTAL

Lower electrolytes, lower glycerol, lower volume

Other: Electrolyte solution with glycerol beverage 1

Electrolyte solution with glycerol beverage 2

EXPERIMENTAL

Higher electrolytes, higher glycerol, lower volume

Other: Electrolyte solution with glycerol beverage 2

Electrolyte solution with glycerol beverage 3

EXPERIMENTAL

Higher electrolytes, higher glycerol, higher volume

Other: Electrolyte solution with glycerol beverage 3

Base with glycerol beverage 1

EXPERIMENTAL

No electrolytes, higher glycerol, lower volume

Other: Base with glycerol, no electrolytes beverage 1

Base with glycerol beverage 2

EXPERIMENTAL

No electrolytes, lower glycerol, mid-volume

Other: Base with glycerol, no electrolytes beverage 2

Base with glycerol beverage 3

EXPERIMENTAL

No electrolytes, higher glycerol, higher volume

Other: Base with glycerol, no electrolytes beverage 3

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

Placebo beverage

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 1

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 2

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 without glycerol beverage 3

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 1

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 2

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.

Electrolyte solution with glycerol beverage 3

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 beverage 1

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 beverage 2

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.

Base with glycerol beverage 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (3)

IMG Academy/GSSI Bradenton Gatorade Sports Science Institute

Bradenton, Florida, 34210, United States

RECRUITING

GCP Research

St. Petersburg, Florida, 33705, United States

RECRUITING

Gatorade Sports Science Institute

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Interventions

Alkalies; Glycerol

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Lindsay Baker, PhD

  PepsiCo R&D/Gatorade and Sports Science Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Baker, PhD

CONTACT

800.884.2867; Lindsay.Baker@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 3, 2025
• Study Start: April 9, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)