An interventional study of Buoy Electrolyte and Water only in Dehydration, Electrolyte Imbalance and Electrolyte Depletion, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
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.
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.
201 studies on the registry are indexed under Dehydration; 28 are open to participants now.
This study's enrollment of 30 is below the median of 43 across 145 interventional studies indexed under Dehydration.
Browse Dehydration studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Visit 1: 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. 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 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 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).
Dietary Supplement: Buoy Electrolyte · Other: Water only · Dietary Supplement: Nuun 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.
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
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 (
Net Fluid Balance
Determined by subtracting the cumulative urine output from the total fluid load consumed
Time frame: 360 minutes after ingestion
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)
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
Bio Impedance
Bio impedance measured through difference in body fat % pre- and post-urine
Time frame: 360-minutes after ingestion
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.
| Milestone | Buoy Electrolyte Then Water Only Then Nuun Electrolyte |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
| Milestone | Buoy Electrolyte Then Water Only Then Nuun Electrolyte |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
| Milestone | Buoy Electrolyte Then Water Only Then Nuun Electrolyte |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Determined by subtracting the cumulative urine output from the total fluid load consumed
| Liter | Buoy Hydration Drops | Water Alone - Control | Nuun Sport Hydration Tabs |
|---|---|---|---|
| Net Fluid Balance | 0.28 ± 0.28 | 0.05 ± 0.32 | 0.03 ± 0.20 |
Sodium levels will be measured
| milliequivalent/L (meq/L) | Buoy Hydration Drops | Water Alone - Control | Nuun Sport Hydration Tabs |
|---|---|---|---|
| Electrolytes in Urine | 39 ± 15 | 58 ± 21 | 48 ± 47 |
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.
| milliOsm/kilogram (mOsm/kg) | Buoy Hydration Drops | Water Alone - Control | Nuun Sport Hydration Tabs |
|---|---|---|---|
| Urine Osmolarity (mOsm/kg) | 1928 ± 544 | 1666 ± 454 | 1866 ± 318 |
Bio impedance measured through difference in body fat % pre- and post-urine
| percentage of body fat difference | Buoy Hydration Drops | Water Alone - Control | Nuun Sport Hydration Tabs |
|---|---|---|---|
| Bio Impedance | 0.75 ± 0.62 | 0.64 ± 0.65 | 0.44 ± 0.32 |
Collected over Adverse events were recorded during each visit (total of 3 visits per participant).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buoy Hydration Drops | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Water Alone - Control | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Nuun Sport Hydration Tabs | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | All Enrolled Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Age, Continuous(Years) | All Enrolled Participants |
|---|---|
| Mean | 29.9 ± 5.6 |
| Sex: Female, Male(Participants) | All Enrolled Participants |
|---|---|
| Female | 16 |
| Male | 14 |
| Race and Ethnicity Not Collected(Participants) | All Enrolled Participants |
|---|
| Region of Enrollment(participants) | All Enrolled Participants |
|---|---|
| United States | 30 |
| Body Weight (kg)(kilograms) | All Enrolled Participants |
|---|---|
| Mean | 82.6 ± 16.9 |
| Body Mass Index (BMI)(kg/m^2) | All Enrolled Participants |
|---|---|
| Mean | 27.7 ± 6.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2023 to primary completion in Apr 2024, 7 months.
Results were first posted in May 2025, 1 year after primary completion.
Of 65 non-industry interventional studies with no phase under Dehydration, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 7 months is below that.
Counting every sponsor, half of 73 studies reached it within 9 months; a quarter within 5 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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