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Completed

NCT Number: NCT05768789

Buoy Electrolyte Study on Hydration Status of Active Men and Women

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Montefiore Hospital, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 (

Primary outcomes

  1. Net Fluid Balance

    Time frame: 360 minutes after ingestion

    Determined by subtracting the cumulative urine output from the total fluid load consumed

  2. Electrolytes in Urine

    Time frame: Urine will be measured during each visit (three total visits that each last 6 hours)

    Sodium levels will be measured

  3. Urine Osmolarity (mOsm/kg)

    Time frame: 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 outcomes

  1. Bio Impedance

    Time frame: 360-minutes after ingestion

    Bio impedance measured through difference in body fat % pre- and post-urine

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

The Impact of Buoy on Hydration Status of Active Men and Women

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2023
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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