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

NCT06654557 | Recruiting

• 1 other identifier: PEP-2412
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Balance

Keywords

hydration; electrolytes; glycerol; carbohtydrate; beverage

Outcome Measures

Primary Outcomes (2)

• Fluid balance (Body Weight)

  Platform scale to the nearest 0.005 kilograms (kg)

  Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

• Fluid balance (Percent (%) change in Body Mass)

  Platform scale to the nearest 0.005 kilograms (kg)

  Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

Secondary Outcomes (15)

• Fluid retention

  % change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

• Urine mass

  Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

• Urine specific gravity

  Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

• Blood sodium

  Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

• Blood glucose

  Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage

Study Arms (7)

Placebo beverage (Parts 1 and 2)

PLACEBO COMPARATOR

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

Placebo beverage (Parts 1 and 2)

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

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

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

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

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

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

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 (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

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

RECRUITING

Study Officials

• Lindsay Baker, PhD

  PepsiCo R&D Life Sciences, Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Baker, PhD

CONTACT

814-883-9454; 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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 23, 2024
• Study Start: September 30, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)