Buoy Electrolyte Study on Hydration Status of Active Men and Women

NCT05768789 | Completed Results DMC

• 1 other identifier: STUDY22090018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Dehydration; Electrolyte Imbalance; Electrolyte Depletion; Fluid and Electrolyte Imbalance

Keywords

dehydration; electrolyte; electrolyte supplement; electrolyte loss; electrolyte ingestion; hydration

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Bio Impedance

  360-minutes after ingestion

Study Arms (1)

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).

Dietary Supplement: Buoy Electrolyte; Other: Water only; Dietary Supplement: Nuun Electrolyte

Interventions

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.

Buoy Electrolyte then Water only then Nuun Electrolyte

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

Buoy Electrolyte then Water only then Nuun Electrolyte

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 (

Buoy Electrolyte then Water only then Nuun Electrolyte

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 152132, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (13)

• 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.

  PMID: 28614817 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.

  PMID: 30609670 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.

  PMID: 20646222 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.

  PMID: 28508338 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.

  PMID: 15212747 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.

  PMID: 17277604 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.

  PMID: 28737585 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.

  PMID: 29368181 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.

  PMID: 29364084 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.

  PMID: 20840563 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.

  PMID: 28126906 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.

  PMID: 33023276 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.

  PMID: 26702122 BACKGROUND

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Harikesh Subramanian, MBBS, MS, D.ABA, ABPM-CI
• Organization: University of Pittsburgh, UPMC

subramanianh4@upmc.edu

412-647-9085

Study Officials

• Harikesh Subramanian, MBBS

  UPMC Department of Anesthesiology and Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology and Perioperative Medicine

Model Details: 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

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: March 14, 2023
• Study Start: September 13, 2023
• Primary Completion: April 27, 2024
• Study Completion: April 27, 2024
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)