Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest

NCT06185595 | Completed

• 1 other identifier: PEP-2311
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the effect of consumption of drinks with varying amounts of glycerol and electrolytes on fluid balance at rest.

Conditions

Hydration

Keywords

hydration; euhydration; fluid balance; fluid retention

Outcome Measures

Primary Outcomes (1)

• Fluid balance

  Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale

  Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes

Secondary Outcomes (12)

• Fluid retention

  Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes

• Urine mass

  Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes

• Urine specific gravity

  Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes

• Blood sodium

  Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes

• Blood glucose

  Screening visit only

Study Arms (6)

Control

PLACEBO COMPARATOR

No sodium, No glycerol

Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Sodium only group 1

EXPERIMENTAL

55 mmol/L sodium

Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Glycerol only

EXPERIMENTAL

4.6% glycerol

Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Sodium and Glycerol group 1

EXPERIMENTAL

55 mmol/L sodium and 4.6% glycerol

Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Sodium only group 2

EXPERIMENTAL

27.5 mmol/L sodium

Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Sodium and Glycerol group 2

EXPERIMENTAL

27.5 mmol/L sodium and 2.3% glycerol

Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.

Interventions

Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. OTHER

9.3 oz (273 ml) aliquot of one of the study beverages every 15 min for a total of 28 oz (828 ml) over a 45-min period, followed by 15 min of rest. Flavored water matched for sweetness, color. flavor, but cannot be matched for saltiness. All sodium-containing drinks will include a base blend of other electrolytes (potassium 15 mmol/L, magnesium 8 mmol/L, and calcium 5 mmol/L).

Control; Glycerol only; Sodium and Glycerol group 1; Sodium and Glycerol group 2; Sodium only group 1; Sodium only group 2

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
• You are 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 as indicated on the general health questionnaire (GHQ), 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
• Able to speak, write, and read English
• 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 (1)

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, 10595, United States

Location

Related Publications (1)

• Baker LB, Hinkley JM, Ozga M, Alfred SL, Merritt JR, De Chavez PJD. A randomized trial modeling the effects of solutions with low to moderate glycerol and sodium concentrations on fluid balance in healthy, active adults. Am J Clin Nutr. 2026 Jan;123(1):101094. doi: 10.1016/j.ajcnut.2025.10.011. Epub 2025 Oct 23.

  PMID: 41138915 DERIVED

Study Officials

• Lindsay Baker, PhD

  PepsiCo, Inc. Sports Science

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 29, 2023
• Study Start: January 8, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)