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

NCT ID: NCT06654557

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-05-30

Brief Summary

The results of a prior study PEP-2311 suggested there was a positive dose-response effect of glycerol and sodium on fluid balance and fluid retention. In addition, inclusion of glycerol resulted in an upward shift in the relationship between sodium concentration and fluid balance. The practical interpretation is that addition of glycerol enables a reduction in sodium concentration compared with a 0% glycerol drink.

In this follow-up study, the investigators hypothesize that 1) fluid balance will be sustained (greater than or not different from baseline) and significantly greater than placebo for 120 min after drinking the test no/low/moderate carbohydrate beverages and 2) fluid balance will not differ between the carbohydrate-electrolyte beverages, but both will be greater than placebo.

Detailed Description

This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.

Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25

Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70

Conditions

Fluid Balance

Study Design

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

Study Groups

Placebo beverage (Parts 1 and 2)

Group Type: PLACEBO_COMPARATOR

Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose.

0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)

Group Type: EXPERIMENTAL

0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)

Group Type: EXPERIMENTAL

0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

Group Type: EXPERIMENTAL

1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

Group Type: EXPERIMENTAL

6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Group Type: EXPERIMENTAL

6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Group Type: EXPERIMENTAL

2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

Intervention Type: OTHER

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Interventions

Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose.

Intervention Type: OTHER

0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Intervention Type: OTHER

0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Intervention Type: OTHER

1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Intervention Type: OTHER

6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Intervention Type: OTHER

6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Intervention Type: OTHER

2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only)

9.3 oz (276 ml) aliquots 3 times for a total of 28 oz (828 ml) over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Subject is male or female

• If female, subject is not pregnant (based on self-report)
• 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, As indicated on the general health questionnaire (GHQ), e.g. cardiovascular, renal, or metabolic diseases
• Subject is not allergic to adhesives (e.g., medical tape)
• Subject is not allergic to kiwi-strawberry flavoring
• 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 (light physical activity only)
• 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 R&D Life Sciences, Sports Science

Locations

PepsiCo R&D, Gatorade Sports Science Institute

Valhalla, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay Baker, PhD

Role: CONTACT

Lindsay.Baker@pepsico.com

814-883-9454

Facility Contacts

Lindsay Baker, PhD

Role: primary

lindsay.baker@pepsico.com

814-883-9454

Matthew Hinkley, PhD

Role: backup

Matt.Hinkley@pepsico.com

914-742-4975

Other Identifiers

PEP-2412

Identifier Type: -

Identifier Source: org_study_id