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

Hydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185595
• Other study ID #: PEP-2311
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: August 15, 2024

Study information

• Verified date: March 2024
• Source: PepsiCo Global R&D
• Contact: Lindsay Baker, PhD
• Phone: 814-883-9454
• Email: Lindsay.Baker[@]pepsico.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject is male or female

• If female, subject is not pregnant

• Subject is 18-50 years of age, inclusive

• 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.

Related Conditions & MeSH terms

• Hydration

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	PepsiCo R&D, Gatorade Sports Science Institute	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid balance	Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Secondary	Fluid retention	As a percent (%)	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Secondary	Urine mass	By urine mass scale in grams (g)	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Secondary	Urine specific gravity	By USG digital pen refractometer	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes
Secondary	Blood sodium	By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mmol/L	Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Secondary	Blood glucose	Glucometer for point of care test in mg/dL	Screening visit only
Secondary	Blood glucose	By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mg/dL	Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Secondary	Percent change in plasma volume	Calculated from hematocrit and hemoglobin concentration	Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Secondary	Serum glycerol concentration	By Sigma Aldrich glycerol assay kit in mmol/L	Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes
Secondary	Blood pressure	mmHg by automatic sphygmomanometer	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Secondary	Heart rate	Beats per minute (bpm) by heart rate monitor	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Secondary	Subjective measures of gastrointestinal discomfort and headache	Visual Analog Scale (VAS) symptom rating of how you feel right now by placing a slash along a 100 millimeter (mm) vertical line anchored from 0 mm (None) to 100 mm (Severe). Fewer symptoms and lower numbers are better.	Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes
Secondary	Menstrual cycle phase	Date of last menstrual period by self-report of female participant	Female participants log menstrual flow throughout study participation. The three study sessions (2-45 days apart) are scheduled to avoid menses and can be completed in the same menstrual cycle, or in 3 different cycles (3 different months) if needed.