Clinical trial NCT05768789: Buoy Electrolyte Study on Hydration Status of Active Men and Women
Official title: The Impact of Buoy on Hydration Status of Active Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Electrolyte Imbalance
Electrolyte Depletion
Fluid and Electrolyte Imbalance
Keywords: dehydration
electrolyte
electrolyte supplement
electrolyte loss
electrolyte ingestion
hydration
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Net Fluid Balance
timeFrame: 360 minutes after ingestion
measure: Electrolytes in Urine
timeFrame: Urine will be measured during each visit (three total visits that each last 6 hours)
measure: Urine Osmolarity (mOsm/kg)
timeFrame: 360 minutes after ingestion
Secondary outcomes:
measure: Bio Impedance
timeFrame: 360-minutes after ingestion
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: UPMC Department of Anesthesiology and Perioperative Medicine
name: Harikesh Subramanian, MBBS
role: PRINCIPAL_INVESTIGATOR
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