Buoy Electrolyte Study on Hydration Status of Active Men and Women

Not Applicable

Completed

Conditions: Fluid and Electrolyte Imbalance
Dehydration
Electrolyte Depletion
Electrolyte Imbalance

Interventions: Other: Water
Dietary Supplement: Buoy Electrolyte
Dietary Supplement: Nuun

Registration Number: NCT05768789

Lead Sponsor: University of Pittsburgh

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Water	Water	Participants will ingest the same quantity of water (1 L) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours.
Buoy Electrolyte Drops	Buoy Electrolyte	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 4 tsps (18 ml) of Buoy diluted in 1 L of water.
Nuun Electrolyte Tablet	Nuun	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).

Primary Outcome Measures

Name	Time	Method
Net Fluid Balance	360 minutes after ingestion	Determined by subtracting the cumulative urine output from the total fluid load consumed
Electrolytes in Urine	Urine will be measured during each visit (three total visits that each last 6 hours)	Sodium levels will be measured
Urine Osmolarity (mOsm/kg)	360 minutes after ingestion	Osmolarity measures the concentration of solutes in urine. This is a key indicator of how concentrated or diluted the urine is, which directly reflects hydration status and kidney function. This can fluctuate depending on how much water the kidneys are excreting or retaining.