Effect of Glycerol-Electrolyte Beverages on Fluid Balance in Healthy Euhydrated Men and Women at Rest
Not Applicable
Completed
- Conditions
- Hydration
- Interventions
- Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.
- Registration Number
- NCT06185595
- Lead Sponsor
- PepsiCo Global R&D
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. No sodium, No glycerol Sodium and Glycerol group 1 Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. 55 mmol/L sodium and 4.6% glycerol Glycerol only Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. 4.6% glycerol Sodium only group 1 Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. 55 mmol/L sodium Sodium only group 2 Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. 27.5 mmol/L sodium Sodium and Glycerol group 2 Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order. 27.5 mmol/L sodium and 2.3% glycerol
- Primary Outcome Measures
Name Time Method Fluid balance Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes Change in body mass to the nearest 0.005 kilogram (kg) using a platform scale
- Secondary Outcome Measures
Name Time Method Urine mass Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes By urine mass scale in grams (g)
Blood pressure Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes mmHg by automatic sphygmomanometer
Urine specific gravity Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes By USG digital pen refractometer
Blood glucose Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mg/dL
Subjective measures of gastrointestinal discomfort and headache Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes 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.
Fluid retention Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes As a percent (%)
Blood sodium Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes By iSTAT Blood Electrolyte and Chemistry Analyzer (CG8+ cartridge) in mmol/L
Percent change in plasma volume Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes Calculated from hematocrit and hemoglobin concentration
Serum glycerol concentration Change from baseline (pre-beverage) to post-beverage Time 0, 60 min, 120 min and 180 minutes By Sigma Aldrich glycerol assay kit in mmol/L
Heart rate Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes Beats per minute (bpm) by heart rate monitor
Menstrual cycle phase 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. Date of last menstrual period by self-report of female participant
Trial Locations
- Locations (1)
PepsiCo R&D, Gatorade Sports Science Institute
🇺🇸Valhalla, New York, United States