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

PepsiCo

Status: Completed

Conditions: Hydration

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06185595

PEP-2311

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 6 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

No sodium, No glycerol

Treatment:

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 group

Description:

55 mmol/L sodium

Treatment:

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

Glycerol only

Experimental group

Description:

4.6% glycerol

Treatment:

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 group

Description:

55 mmol/L sodium and 4.6% glycerol

Treatment:

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 group

Description:

27.5 mmol/L sodium

Treatment:

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 group

Description:

27.5 mmol/L sodium and 2.3% glycerol

Treatment:

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