Dehydration, Electrolyte Depletion, Electrolyte Imbalance, Fluid and Electrolyte Imbalance
Conditions
Keywords
dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration
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.
Interventions
DIETARY_SUPPLEMENTBuoy Electrolyte
Each subject consumed Beverage 1 (Buoy Hydration Drops) at a dose containing 600 mg/L of Na+ over 4 hours while measuring urine output over 6 hours.
OTHERWater only
Each subjected ingested 1 L of Kirkland® bottled water at a rate of 6.25% of the total amount of water every 15 minutes for four hours
DIETARY_SUPPLEMENTNuun Electrolyte
Each subject consumed 1 L of water with two dissolved Nuun® Sport Hydration tabs (Nuun, Seattle, WA), containing 600 mg of sodium, over 30 minutes (2 equal volumes every 15 minutes) while measuring urine output over 6 hours (
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All participants received the interventions in the same order one after the other on different days (Buoy, then Water, then Nuun) to complete the 3 arms of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrolytes in Urine | Urine will be measured during each visit (three total visits that each last 6 hours) | Sodium levels will be measured |
| Net Fluid Balance | 360 minutes after ingestion | Determined by subtracting the cumulative urine output from the total fluid load consumed |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bio Impedance | 360-minutes after ingestion | Bio impedance measured through difference in body fat % pre- and post-urine |
Countries
United States
Participant flow
Recruitment details
All enrolled participants completed 3 separate visits in a crossover design, each visit consisting of a different intervention. All participants completed the visits and interventions in the same order as listed below.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants All enrolled participants completed 3 separate visits, each visit consisting of a different intervention. All participants completed the visits and interventions in the same order as listed below.
Visit 1 - Buoy Electrolyte: Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours. 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.
Visit 2 - Water Alone: Water serves as a control. 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.
Visit 3 - Nuun Electrolyte Tablet: Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight. 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). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Enrolled Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Age, Continuous | 29.9 Years STANDARD_DEVIATION 5.6 | — |
| Body Mass Index (BMI) | 27.7 kg/m^2 STANDARD_DEVIATION 6.1 | — |
| Body Weight (kg) | 82.6 kilograms STANDARD_DEVIATION 16.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Electrolytes in Urine
Sodium levels will be measured
Time frame: Urine will be measured during each visit (three total visits that each last 6 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buoy Hydration Drops | Electrolytes in Urine | 39 milliequivalent/L (meq/L) | Standard Deviation 15 |
| Water Alone - Control | Electrolytes in Urine | 58 milliequivalent/L (meq/L) | Standard Deviation 21 |
| Nuun Sport Hydration Tabs | Electrolytes in Urine | 48 milliequivalent/L (meq/L) | Standard Deviation 47 |
Primary
Net Fluid Balance
Determined by subtracting the cumulative urine output from the total fluid load consumed
Time frame: 360 minutes after ingestion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buoy Hydration Drops | Net Fluid Balance | 0.28 Liter | Standard Deviation 0.28 |
| Water Alone - Control | Net Fluid Balance | 0.05 Liter | Standard Deviation 0.32 |
| Nuun Sport Hydration Tabs | Net Fluid Balance | 0.03 Liter | Standard Deviation 0.2 |
Primary
Urine Osmolarity (mOsm/kg)
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.
Time frame: 360 minutes after ingestion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buoy Hydration Drops | Urine Osmolarity (mOsm/kg) | 1928 milliOsm/kilogram (mOsm/kg) | Standard Deviation 544 |
| Water Alone - Control | Urine Osmolarity (mOsm/kg) | 1666 milliOsm/kilogram (mOsm/kg) | Standard Deviation 454 |
| Nuun Sport Hydration Tabs | Urine Osmolarity (mOsm/kg) | 1866 milliOsm/kilogram (mOsm/kg) | Standard Deviation 318 |
Secondary
Bio Impedance
Bio impedance measured through difference in body fat % pre- and post-urine
Time frame: 360-minutes after ingestion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Buoy Hydration Drops | Bio Impedance | 0.75 percentage of body fat difference | Standard Deviation 0.62 |
| Water Alone - Control | Bio Impedance | 0.64 percentage of body fat difference | Standard Deviation 0.65 |
| Nuun Sport Hydration Tabs | Bio Impedance | 0.44 percentage of body fat difference | Standard Deviation 0.32 |