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

NCT ID: NCT06185595

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-06-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Control

No sodium, No glycerol

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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).

Sodium only group 1

55 mmol/L sodium

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Glycerol only

4.6% glycerol

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Sodium and Glycerol group 1

55 mmol/L sodium and 4.6% glycerol

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Sodium only group 2

27.5 mmol/L sodium

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Sodium and Glycerol group 2

27.5 mmol/L sodium and 2.3% glycerol

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Interventions

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

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

PepsiCo, Inc. Sports Science

Locations

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, United States

Countries

United States

References

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. 2025 Oct 23:S0002-9165(25)00615-X. doi: 10.1016/j.ajcnut.2025.10.011. Online ahead of print.

Reference Type: DERIVED

PMID: 41138915 (View on PubMed)

Other Identifiers

PEP-2311

Identifier Type: -

Identifier Source: org_study_id