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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buoy Electrolyte then Water only then Nuun Electrolyte | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buoy Electrolyte | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Net Fluid Balance | Determined by subtracting the cumulative urine output from the total fluid load consumed | 360 minutes after ingestion |
| Electrolytes in Urine | Sodium levels will be measured | 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. | 360 minutes after ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Bio Impedance | Bio impedance measured through difference in body fat % pre- and post-urine | 360-minutes after ingestion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harikesh Subramanian, MBBS | UPMC Department of Anesthesiology and Perioperative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Montefiore Hospital | Pittsburgh | Pennsylvania | 152132 | United States | ||
| UPMC Presbyterian |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28614817 | Background | Perrier ET. Shifting Focus: From Hydration for Performance to Hydration for Health. Ann Nutr Metab. 2017;70 Suppl 1:4-12. doi: 10.1159/000462996. Epub 2017 Jun 15. | |
| 30609670 | Background | Liska D, Mah E, Brisbois T, Barrios PL, Baker LB, Spriet LL. Narrative Review of Hydration and Selected Health Outcomes in the General Population. Nutrients. 2019 Jan 1;11(1):70. doi: 10.3390/nu11010070. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buoy Electrolyte Then Water Only Then Nuun Electrolyte | 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 : Buoy Electrolyte |
| |||||||||||||
| Visit 2: Water Only |
| |||||||||||||
| Visit 3: Nuun Electrolyte |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Net Fluid Balance | Determined by subtracting the cumulative urine output from the total fluid load consumed | Posted | Mean | Standard Deviation | Liter | 360 minutes after ingestion |
|
Adverse events were recorded during each visit (total of 3 visits per participant).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buoy Hydration Drops | Visit 1 consisted of the Buoy Hydration Drops beverage intervention at a dose containing 600mg/Litre of Na+ over 4 hours. All 30 participants completed visit 1. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harikesh Subramanian, MBBS, MS, D.ABA, ABPM-CI | University of Pittsburgh, UPMC | 412-647-9085 | subramanianh4@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2024 | Apr 3, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 6, 2024 | Apr 3, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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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
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| Water only | Other | 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 |
|
| Nuun Electrolyte | Dietary Supplement | 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 ( |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 20646222 | Background | Popkin BM, D'Anci KE, Rosenberg IH. Water, hydration, and health. Nutr Rev. 2010 Aug;68(8):439-58. doi: 10.1111/j.1753-4887.2010.00304.x. |
| 28508338 | Background | Nuccio RP, Barnes KA, Carter JM, Baker LB. Fluid Balance in Team Sport Athletes and the Effect of Hypohydration on Cognitive, Technical, and Physical Performance. Sports Med. 2017 Oct;47(10):1951-1982. doi: 10.1007/s40279-017-0738-7. |
| 15212747 | Background | Von Duvillard SP, Braun WA, Markofski M, Beneke R, Leithauser R. Fluids and hydration in prolonged endurance performance. Nutrition. 2004 Jul-Aug;20(7-8):651-6. doi: 10.1016/j.nut.2004.04.011. |
| 17277604 | Background | American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597. |
| 28737585 | Background | Lee EC, Fragala MS, Kavouras SA, Queen RM, Pryor JL, Casa DJ. Biomarkers in Sports and Exercise: Tracking Health, Performance, and Recovery in Athletes. J Strength Cond Res. 2017 Oct;31(10):2920-2937. doi: 10.1519/JSC.0000000000002122. |
| 29368181 | Background | Kenefick RW. Drinking Strategies: Planned Drinking Versus Drinking to Thirst. Sports Med. 2018 Mar;48(Suppl 1):31-37. doi: 10.1007/s40279-017-0844-6. |
| 29364084 | Background | Love TD, Baker DF, Healey P, Black KE. Measured and perceived indices of fluid balance in professional athletes. The use and impact of hydration assessment strategies. Eur J Sport Sci. 2018 Apr;18(3):349-356. doi: 10.1080/17461391.2017.1418910. Epub 2018 Jan 24. |
| 20840563 | Background | Maughan RJ, Shirreffs SM. Development of hydration strategies to optimize performance for athletes in high-intensity sports and in sports with repeated intense efforts. Scand J Med Sci Sports. 2010 Oct;20 Suppl 2:59-69. doi: 10.1111/j.1600-0838.2010.01191.x. |
| 28126906 | Background | Evans GH, James LJ, Shirreffs SM, Maughan RJ. Optimizing the restoration and maintenance of fluid balance after exercise-induced dehydration. J Appl Physiol (1985). 2017 Apr 1;122(4):945-951. doi: 10.1152/japplphysiol.00745.2016. Epub 2017 Jan 26. |
| 33023276 | Background | Pence J, Bloomer RJ. Impact of Nuun Electrolyte Tablets on Fluid Balance in Active Men and Women. Nutrients. 2020 Oct 2;12(10):3030. doi: 10.3390/nu12103030. |
| 26702122 | Background | Maughan RJ, Watson P, Cordery PA, Walsh NP, Oliver SJ, Dolci A, Rodriguez-Sanchez N, Galloway SD. A randomized trial to assess the potential of different beverages to affect hydration status: development of a beverage hydration index. Am J Clin Nutr. 2016 Mar;103(3):717-23. doi: 10.3945/ajcn.115.114769. Epub 2015 Dec 23. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 |
| Nuun Sport Hydration Tabs |
Visit 3 consisted of the Nunn Sport Hydration Tabs in which each subject consumed 1L of water with two dissolved tabs, containing 600mg of Na+ over 30 minutes. All 30 participants completed visit 3. |
|
|
| Primary | Electrolytes in Urine | Sodium levels will be measured | Posted | Mean | Standard Deviation | milliequivalent/L (meq/L) | Urine will be measured during each visit (three total visits that each last 6 hours) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | milliOsm/kilogram (mOsm/kg) | 360 minutes after ingestion |
|
|
|
| Secondary | Bio Impedance | Bio impedance measured through difference in body fat % pre- and post-urine | Posted | Mean | Standard Deviation | percentage of body fat difference | 360-minutes after ingestion |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Water Alone - Control | Visit 2 consisted of water alone as a control in which each subject ingested 1L of water at a rate of 6/25% of the calculated amount of water every 15 minutes for 4 hours. All 30 participants completed visit 2. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Nuun Sport Hydration Tabs | Visit 3 consisted of the Nunn Sport Hydration Tabs in which each subject consumed 1L of water with two dissolved tabs, containing 600mg of Na+ over 30 minutes. All 30 participants completed visit 3. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D013568 | Pathological Conditions, Signs and Symptoms |