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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.
This is a two-part study. Subjects will be asked to complete either Part 1 or Part 2 of this study. Subjects can participate in both parts of the study if they are interested and available to complete all trials. However, they will be asked to complete Part 1 before enrolling in Part 2 of the study. Dosing days are separated by 2-15 days.
Objective 1) To compare the effect of consumption of four no/low/moderate carbohydrate drinks with high electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=25
Objective 2) To compare the effect of consumption of two moderate carbohydrate drinks with low electrolyte concentrations vs. placebo on fluid balance at rest. To enroll N=70
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo beverage (Parts 1 and 2) | Placebo Comparator |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo beverage, kiwi-strawberry flavor (Part 1 and Part 2) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid balance (Body Weight) | Platform scale to the nearest 0.005 kilograms (kg) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Fluid balance (Percent (%) change in Body Mass) | Platform scale to the nearest 0.005 kilograms (kg) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid retention | Platform scale to the nearest 0.005 kilograms (kg), unit percent (%) | % change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Urine mass |
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Inclusion Criteria:
Subject is male or female
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Baker, PhD | Contact | 814-883-9454 | Lindsay.Baker@pepsico.com |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Baker, PhD | PepsiCo R&D Life Sciences, Sports Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PepsiCo R&D, Gatorade Sports Science Institute | Recruiting | Valhalla | New York | 10595 | United States |
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| 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Experimental |
|
| 0% carbohydrate electrolyte solution with glycerol beverage (Part 1 only) | Other | 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. Beverage matched to placebo for color and flavor. |
|
| 0% carbohydrate electrolyte solution without glycerol beverage (Part 1 only) | Other | 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. Beverage matched to placebo for color and flavor. |
|
| 1% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) | Other | 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. Beverage matched to placebo for color and flavor. |
|
| 6% carbohydrate electrolyte solution with glycerol beverage (Parts 1 and 2) | Other | 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. Beverage matched to placebo for color and flavor. |
|
| 6% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Other | 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. Beverage matched to placebo for color and flavor. |
|
| 2% carbohydrate electrolyte solution without glycerol beverage (Part 2 only) | Other | 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. Beverage matched to placebo for color and flavor. |
|
Graduated cylinder on scale to the nearest 0.01 grams |
| Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Urine specific gravity | USG digital pen refractometer (Atago), no unit | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Blood sodium | Fingerstick sampling, unit millimoles per liter (mmol/L), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Blood glucose | Fingerstick sampling, unit milligrams per deciliter (mg/dl), iSTAT Blood Electrolyte and Chemistry Analyzer (CHEM8+ cartridge) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Percent change in plasma volume | Fingerstick sampling, calculated from hematocrit and hemoglobin concentration percent (%) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Serum glycerol concentration | Fingerstick sampling unit millimoles per liter (mmol/L) using Sigma Aldrich glycerol assay kit | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Serum osmolality | Fingerstick sampling, unit milliosmoles per kilogram of water (mOsm/Kg H20) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Saliva osmolality | Measured directly from the tongue using a handheld MX3 Diagnostics device, unit milliosmoles per kilogram of water (mOsm/kg H2O) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Blood pressure (systolic/diastolic) | Automatic sphygmomanometer unit millimeters of mercury (mm/Hg) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Heart rate | Heart rate monitor, unit beats per minute (bpm) | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Subjective measure of headache | One item on a 100 point visual analog scale anchored from 0=No headache to 100=Severe headache | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Subjective measure of lightheadedness | One item on a 100 point visual analog scale anchored from 0=No lightheadedness to 100=Severe lightheadedness | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Subjective measures of gastrointestinal discomfort | Eight items on a 100 point visual analog scale (stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea anchored frrom 0= None to 100=Severe | Change each test day from pre-beverage baseline (-60 minutes) to post-beverage Time 0 minutes, 30 minutes, 60 minutes, 90 minutes,120 minutes, and 150 minutes post 3rd (last) beverage |
| Menstrual categorization | Using Elliott-Sale chart, 2023 to categorize menstrual/hormonal contraceptive status for those who have not yet reached perimenopause/menopause. This is a decision-tree chart, not a scale. | Assessed at Screening Visit |