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The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.
The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo beverage | Placebo Comparator | Base beverage, no electrolytes, no glycerol |
|
| Electrolyte solution without glycerol beverage 1 | Experimental | Higher electrolytes lower volume |
|
| Electrolyte solution without glycerol beverage 2 | Experimental | Lower electrolytes mid-volume |
|
| Electrolyte solution without glycerol beverage 3 | Experimental | Higher electrolytes higher volume |
|
| Electrolyte solution with glycerol beverage 1 | Experimental | Lower electrolytes, lower glycerol, lower volume |
|
| Electrolyte solution with glycerol beverage 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo beverage, kiwi-strawberry flavor | Other | 9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fluid balance | Calculated as change in body mass kg and % | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Urine mass | (g) | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Urine specific gravity | (au) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Baker, PhD | Contact | 800.884.2867 | Lindsay.Baker@pepsico.com |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Baker, PhD | PepsiCo R&D/Gatorade and Sports Science Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMG Academy/GSSI Bradenton Gatorade Sports Science Institute | Recruiting | Bradenton | Florida | 34210 | United States |
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Higher electrolytes, higher glycerol, lower volume |
|
| Electrolyte solution with glycerol beverage 3 | Experimental | Higher electrolytes, higher glycerol, higher volume |
|
| Base with glycerol beverage 1 | Experimental | No electrolytes, higher glycerol, lower volume |
|
| Base with glycerol beverage 2 | Experimental | No electrolytes, lower glycerol, mid-volume |
|
| Base with glycerol beverage 3 | Experimental | No electrolytes, higher glycerol, higher volume |
|
| Electrolyte solution without glycerol beverage 1 | Other | 4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Electrolyte solution without glycerol beverage 2 | Other | 6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Electrolyte solution without glycerol beverage 3 | Other | 9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Electrolyte solution with glycerol beverage 1 | Other | 4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Electrolyte solution with glycerol beverage 2 | Other | 4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Electrolyte solution with glycerol beverage 3 | Other | 9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Base with glycerol, no electrolytes beverage 1 | Other | 4 oz 3 times for a total of 12 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Base with glycerol, no electrolytes beverage 2 | Other | 6.7 oz 3 times for a total of 20 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Base with glycerol, no electrolytes beverage 3 | Other | 9.3.oz 3 times for a total of 28 oz over a 35 min period followed by 25 min rest until Time 0 post-dose. Beverage matched to placebo for color and flavor. |
|
| Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Urine osmolality | (mosmol/kg) | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Whole blood hematocrit | (%) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Whole blood hemoglobin concentration | (g/dl) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum sodium concentration | (mmol/L) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum potassium concentration | (mmol/L) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum chloride concentration (mmol/L) | (mmol/L) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum glucose concentration | (mg/dl) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum glycerol concentration | (mmol/L) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum copeptin concentration | (pmol/L) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Serum osmolality | (mosmol/kg) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes |
| Blood pressure | (systolic/diastolic) (mmHg) | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Heart rate | (bpm) | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Subjective measures of gastrointestinal discomfort and headache (VAS) | Rated on a 100 point scale from none to severe for headache, lightheaded, stomach upset, nausea, burping, stomach bloating, abdominal discomfort, stomach fullness, vomiting, diarrhea). | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes |
| Menstrual categorization | Current status (e.g., contraception, regular periods or not, etc.) | Screening visit |
| Adverse Events | Documented changes in health and symptoms | From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6) |
| GCP Research | Recruiting | St. Petersburg | Florida | 33705 | United States |
|
| Gatorade Sports Science Institute | Recruiting | Valhalla | New York | 10595 | United States |
|
| ID | Term |
|---|---|
| D000468 | Alkalies |
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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