Buoy Electrolyte Study on Hydration Status of Active Men and Women

Phase

N/A

Condition

Low Blood Sodium (Hyponatremia)

Low Blood Pressure (Hypotension)

Treatment

Nuun

Buoy Electrolyte

Water only

Clinical Study ID

NCT05768789

STUDY22090018

Ages 18-45
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 mustbe consistent each visit
Without active infection of any kind
Engaged in exercise three or more hours per week

Exclusion

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, historyof 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 orgreater than 140/90.

Study Design

Nuun

September 13, 2023

April 27, 2024

Study 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.

Connect with a study center

UPMC Montefiore Hospital
Pittsburgh, Pennsylvania 152132
United States
Site Not Available
UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
United States
Site Not Available

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