Recruiting

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

Sponsor:

PepsiCo Global R&D

Code:

NCT06654557

Conditions

Fluid Balance

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

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

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

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

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

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

Study Details

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

Study ID

NCT06654557

Start date

Sep 30, 2024

Status verified date

Feb, 2025

Completion date

May 30, 2025

Anticipated

Primary completion date

May 30, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

95 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo beverage (Parts 1 and 2)

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

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

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

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

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

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

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.

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