Buoy Electrolyte Study on Hydration Status of Active Men and Women
NCT ID: NCT05768789
Last Updated: 2025-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-09-13
2024-04-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Buoy Electrolyte then Water only then Nuun Electrolyte
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).
Buoy 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.
Water 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
Nuun 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 (
Interventions
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Buoy 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.
Water 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
Nuun 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 (
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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Harikesh Subramanian
Assistant Professor of Anesthesiology and Perioperative Medicine
Principal Investigators
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Harikesh Subramanian, MBBS
Role: PRINCIPAL_INVESTIGATOR
UPMC Department of Anesthesiology and Perioperative Medicine
Locations
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UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY22090018
Identifier Type: -
Identifier Source: org_study_id
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