Fluid Balance
Conditions
Keywords
hydration, electrolytes, glycerol, beverage
Brief summary
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.
Interventions
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
OTHERElectrolyte solution without glycerol beverage 1
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.
OTHERElectrolyte solution without glycerol beverage 2
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.
OTHERElectrolyte solution without glycerol beverage 3
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.
OTHERElectrolyte solution with glycerol beverage 1
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.
OTHERElectrolyte solution with glycerol beverage 2
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.
OTHERElectrolyte solution with glycerol beverage 3
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.
OTHERBase with glycerol, no electrolytes beverage 1
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.
OTHERBase with glycerol, no electrolytes beverage 2
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.
OTHERBase with glycerol, no electrolytes beverage 3
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.
Sponsors
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is male or female * If female, subject is not pregnant * Subject is 18-50 years of age, inclusive * Subject is 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 (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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid balance | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | Calculated as change in body mass kg and % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine specific gravity | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | (au) |
| Urine osmolality | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | (mosmol/kg) |
| Whole blood hematocrit | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (%) |
| Whole blood hemoglobin concentration | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (g/dl) |
| Serum sodium concentration | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (mmol/L) |
| Serum potassium concentration | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (mmol/L) |
| Serum chloride concentration (mmol/L) | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (mmol/L) |
| Serum glucose concentration | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (mg/dl) |
| Urine mass | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | (g) |
| Serum copeptin concentration | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (pmol/L) |
| Serum osmolality | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (mosmol/kg) |
| Blood pressure | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | (systolic/diastolic) (mmHg) |
| Heart rate | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | (bpm) |
| Subjective measures of gastrointestinal discomfort and headache (VAS) | Change from baseline (pre-beverage) to post-beverage Time 30, 60, 90,120, 150,180 and 210 minutes | 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). |
| Menstrual categorization | Screening visit | Current status (e.g., contraception, regular periods or not, etc.) |
| Adverse Events | From Screening (Visit 1) through the fifth and final beverage testing day (Visit 6) | Documented changes in health and symptoms |
| Serum glycerol concentration | Change from baseline (pre-beverage) to post-beverage Time 30, 90,150 and 210 minutes | (mmol/L) |
Countries
United States
Contacts
Primary ContactLindsay Baker, PhD
Outcome results
None listed