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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hydration

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>No sodium, No glycerol | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.<br>* 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).<br>|
| Experimental: Sodium only group 1<br>55 mmol/L sodium | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.<br>* 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).<br>|
| Experimental: Glycerol only<br>4.6% glycerol | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.<br>* 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).<br>|
| Experimental: Sodium and Glycerol group 1<br>55 mmol/L sodium and 4.6% glycerol | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.<br>* 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).<br>|
| Experimental: Sodium only group 2<br>27.5 mmol/L sodium | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.<br>* 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).<br>|
| Experimental: Sodium and Glycerol group 2<br>27.5 mmol/L sodium and 2.3% glycerol | Other: Beverage. Incomplete block where each participant will complete 3 of the 6 possible glycerol-sodium blends in random order.<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid retention | As a percent (%) | Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90,120 and 180 minutes | 
| 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 | 
| 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 | 
| 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 | 
| Blood glucose | Glucometer for point of care test in mg/dL | Screening visit only | 
| 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 | 
| 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 | 
| 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 | 
| Blood pressure | mmHg by automatic sphygmomanometer | Change from baseline (pre-beverage) to post-beverage Time 0, 30, 60, 90, 120 and 180 minutes | 
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydration, euhydration, fluid balance, fluid retention