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Buoy Electrolyte Study on Hydration Status of Active Men and Women

Primary Purpose

Dehydration, Electrolyte Imbalance, Electrolyte Depletion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buoy Electrolyte
Nuun
Water
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dehydration focused on measuring dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UPMC Montefiore HospitalRecruiting
  • UPMC PresbyterianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Buoy Electrolyte Drops

Nuun Electrolyte Tablet

Water

Arm Description

The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. The recommended Buoy dosage is ⅓ tsp in 237 ml of water (50mg Na+) multiple times a day (Table 1). Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 2 tsps (9.84 ml) of Buoy diluted in 4% of total body water (TBW), calculated based on subject's weight. Equation will be [patient weight (kg) * 0.6 (* 0.8 for women) = total body water * 4.0% = liters of water consumed over 6h] (Ex: Assuming a male subject weighed 70 kg: 70 * 0.6 = 42 kg TBW * 4.0% = 1.68 L of water/6h). Not to exceed a threshold of 2.5 L volume total. Therefore, a 70 kg subject would consume 9.84 ml of Buoy in 1.68 L of water over 4h. They will consume 6.25% of the total volume every 15min for 4h (105 ml for a 70kg subject).

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). Then they will drink free water for the remaining 3.5 h to equaling total amount of water consumed during Visit 1 and 2. (Ex: for a 70 kg male subject for a total volume consumption of 4% TBW they will consume 1.68 L over 4 hour. The first 1L consumed with Nuun during the first 30 min, and the remaining 680 ml of electrolyte-free water consumed during the next 3.5h (49 ml free water every 15 min).

Participants will ingest the same quantity of water (4% of TBW) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours. Not to exceed a threshold of 2.5 L to avoid the risk of water intoxication (see adverse events).

Outcomes

Primary Outcome Measures

Net fluid balance
Determined by subtracting the cumulative urine output from the total fluid load consumed
Electrolytes in urine
Sodium, potassium, and chloride levels will be measured
Blood labs
Venous whole blood will be collected using phlebotomy and 100ul will be analyzed using an i-STAT.

Secondary Outcome Measures

Bioimpedence
Bioimpedence measured after each urine collection

Full Information

First Posted
October 25, 2022
Last Updated
September 20, 2023
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05768789
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Electrolyte Imbalance, Electrolyte Depletion, Fluid and Electrolyte Imbalance
Keywords
dehydration, electrolyte, electrolyte supplement, electrolyte loss, electrolyte ingestion, hydration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Buoy Electrolyte Drops
Arm Type
Experimental
Arm Description
The goal is to give 600mg of Na+ over 4 hours while measuring urine output over 6 hours. The recommended Buoy dosage is ⅓ tsp in 237 ml of water (50mg Na+) multiple times a day (Table 1). Therefore, to safely achieve a total dose 600mg Na+ (6-fold increase from single dose) we will use 2 tsps (9.84 ml) of Buoy diluted in 4% of total body water (TBW), calculated based on subject's weight. Equation will be [patient weight (kg) * 0.6 (* 0.8 for women) = total body water * 4.0% = liters of water consumed over 6h] (Ex: Assuming a male subject weighed 70 kg: 70 * 0.6 = 42 kg TBW * 4.0% = 1.68 L of water/6h). Not to exceed a threshold of 2.5 L volume total. Therefore, a 70 kg subject would consume 9.84 ml of Buoy in 1.68 L of water over 4h. They will consume 6.25% of the total volume every 15min for 4h (105 ml for a 70kg subject).
Arm Title
Nuun Electrolyte Tablet
Arm Type
Experimental
Arm Description
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). Then they will drink free water for the remaining 3.5 h to equaling total amount of water consumed during Visit 1 and 2. (Ex: for a 70 kg male subject for a total volume consumption of 4% TBW they will consume 1.68 L over 4 hour. The first 1L consumed with Nuun during the first 30 min, and the remaining 680 ml of electrolyte-free water consumed during the next 3.5h (49 ml free water every 15 min).
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Participants will ingest the same quantity of water (4% of TBW) at a rate of 6.25% of the calculated amount of water every 15 min for 4 hours. Not to exceed a threshold of 2.5 L to avoid the risk of water intoxication (see adverse events).
Intervention Type
Dietary Supplement
Intervention Name(s)
Buoy Electrolyte
Intervention Description
Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nuun
Intervention Description
Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight.
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Water serves as a control
Primary Outcome Measure Information:
Title
Net fluid balance
Description
Determined by subtracting the cumulative urine output from the total fluid load consumed
Time Frame
Urine will be measured during each visit (three total visits that each last 6 hours)
Title
Electrolytes in urine
Description
Sodium, potassium, and chloride levels will be measured
Time Frame
Urine will be measured during each visit (three total visits that each last 6 hours)
Title
Blood labs
Description
Venous whole blood will be collected using phlebotomy and 100ul will be analyzed using an i-STAT.
Time Frame
Venous blood collection will occur at the screening visit and as necessary pending any changes to the patient's medical history and status.
Secondary Outcome Measure Information:
Title
Bioimpedence
Description
Bioimpedence measured after each urine collection
Time Frame
Each urine collection occurs for a total of 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harikesh Subramanian, MBBS
Phone
412-647-2994
Email
subramanianh4@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nika Zharichenko, MHS
Phone
412-647-2994
Email
zharichenkon3@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harikesh Subramanian, MBBS
Organizational Affiliation
UPMC Department of Anesthesiology and Perioperative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Montefiore Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
152132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nika Zharichenko
Email
zharichenkon3@upmc.edu
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nika Zharichenko
Email
zharichenkon3@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28614817
Citation
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Results Reference
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Results Reference
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Citation
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Results Reference
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28508338
Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Buoy Electrolyte Study on Hydration Status of Active Men and Women

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