Buoy Electrolyte Study on Hydration Status of Active Men and Women
Dehydration, Electrolyte Imbalance, Electrolyte Depletion
About this trial
This is an interventional prevention trial for Dehydration focused on measuring dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration
Eligibility Criteria
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.
Sites / Locations
- UPMC Montefiore HospitalRecruiting
- UPMC PresbyterianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Buoy Electrolyte Drops
Nuun Electrolyte Tablet
Water
The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. The recommended Buoy dosage is ⅓ tsp in 237 ml of water (50mg Na+) multiple times a day (Table 1). Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 2 tsps (9.84 ml) of Buoy diluted in 4% of total body water (TBW), calculated based on subject's weight. Equation will be [patient weight (kg) * 0.6 (* 0.8 for women) = total body water * 4.0% = liters of water consumed over 6h] (Ex: Assuming a male subject weighed 70 kg: 70 * 0.6 = 42 kg TBW * 4.0% = 1.68 L of water/6h). Not to exceed a threshold of 2.5 L volume total. Therefore, a 70 kg subject would consume 9.84 ml of Buoy in 1.68 L of water over 4h. They will consume 6.25% of the total volume every 15min for 4h (105 ml for a 70kg subject).
The goal is to give a one-time dose of Nuun (600mg Na+) at the start of the trial, diluted in 1L water to be consumed within 30 min (similar to prior published data, Pence 2020). Then they will drink free water for the remaining 3.5 h to equaling total amount of water consumed during Visit 1 and 2. (Ex: for a 70 kg male subject for a total volume consumption of 4% TBW they will consume 1.68 L over 4 hour. The first 1L consumed with Nuun during the first 30 min, and the remaining 680 ml of electrolyte-free water consumed during the next 3.5h (49 ml free water every 15 min).
Participants will ingest the same quantity of water (4% of TBW) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours. Not to exceed a threshold of 2.5 L to avoid the risk of water intoxication (see adverse events).