Dehydration Clinical Trial
Official title:
The Impact of Buoy on Hydration Status of Active Men and Women
Buoy is an all-natural, organic, FDA compliant dietary electrolyte supplement that can be dissolved in 8-12oz water (or other liquid) and provide electrolytes in servings of 1/3 teaspoon. This study will evaluate Buoy in hydrating active adults.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Male or female, >18 to 45 years of age - Freely given written consent - Non-tobacco users - Negative pregnancy test in women of childbearing potential - BMI < 35 kg/m2 - GFR > 60 ml/min - No known underlying medical condition - Willing to refrain from EtOH for 24h prior to test day - Willing to refrain from strenuous exercise for 24 h prior to each test day - Acceptable to have one 8oz cup of coffee/liquid on the morning of the test, but must be consistent each visit - Without active infection of any kind - Engaged in exercise three or more hours per week Exclusion Criteria: - Abnormal creatinine (Cr > 1.2). - Proteinuria / hematuria / glucosuria based on urine dipstick. - Diagnosed medical condition that would impede results (CHF, HTN, CAD, CKD, history of electrolyte abnormality). - Pregnancy - Use of diuretics within past 2 weeks - Obesity (BMI > 35) - Active infection based on symptoms (bacterial or viral) - Hemodynamic abnormality at screening visit: Blood pressure less than 100/60 or greater than 140/90. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Montefiore Hospital | Pittsburgh | Pennsylvania |
United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net fluid balance | Determined by subtracting the cumulative urine output from the total fluid load consumed | Urine will be measured during each visit (three total visits that each last 6 hours) | |
Primary | Electrolytes in urine | Sodium, potassium, and chloride levels will be measured | Urine will be measured during each visit (three total visits that each last 6 hours) | |
Primary | Blood labs | Venous whole blood will be collected using phlebotomy and 100ul will be analyzed using an i-STAT. | Venous blood collection will occur at the screening visit and as necessary pending any changes to the patient's medical history and status. | |
Secondary | Bioimpedence | Bioimpedence measured after each urine collection | Each urine collection occurs for a total of 6 hours |
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