Buoy Electrolyte Study on Hydration Status of Active Men and Women

Study Overview
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Brief Summary
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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.

Detailed Description
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Prior to initiation of the study, participants will have a screening visit to complete informed consent and health history. The history for females will include their last date for menstruation and/or birth control method to take into consideration the effects of ovulation on water retention. During this visit we will measure heart rate, blood pressure, height, weight. Females will be administered a urine pregnancy test. Participants must refrain from vigorous exercise within 24 hours of study visit. Participants will fast (food) overnight for 10h prior to initiation of test. Upon waking they are asked to empty their bowel & bladder. They can consume one 8oz cup of coffee or other liquid. They will present at 7-8am at which time they will be asked to empty their bladder again. After resting for 5 minutes baseline vitals will be taken, including blood pressure, heart rate, weight, bioimpedance. Urinalysis dipstick for protein/blood/glucose and i-STAT measurement for creatinine and electrolytes on Visit 1 to confirm eligibility. For Visit 2 and Visit 3, the participant will be asked to review medical history and any change in status may warrant an additional baseline creatinine and blood/protein test to confirm eligibility. Additional food or beverage will not be allowed throughout the study period. All studies will be repeated in the same subject using either Buoy (intervention) or water (control) or Nuun (intervention). Urine will be collected at four specific timepoints during the intervention and the volume will be recorded. If participants need to urinate between scheduled collection times, urine will be collected, volume recorded, and combined with the urine collection of the following timepoint. These urine samples will be measured and a fraction of it will be sent to the lab to be tested for the following electrolytes: sodium, potassium, chloride and urine osmolarity. Urine creatinine will also be tested at these timepoints.

Official Title
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The Impact of Buoy on Hydration Status of Active Men and Women

Conditions
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Dehydration, Electrolyte Imbalance, Electrolyte Depletion, Fluid and Electrolyte Imbalance

Intervention / Treatment
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* Dietary Supplement: Buoy Electrolyte
* Dietary Supplement: Nuun
* Other: Water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buoy Electrolyte Drops<br>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). | Dietary Supplement: Buoy Electrolyte<br>* Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours.<br>|
| Experimental: Nuun Electrolyte Tablet<br>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). | Dietary Supplement: Nuun<br>* Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight.<br>|
| Placebo Comparator: Water<br>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). | Other: Water<br>* Water serves as a control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioimpedence | Bioimpedence measured after each urine collection | Each urine collection occurs for a total of 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration