Buoy Electrolyte Study on Hydration Status of Active Men and Women

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768789
• Other study ID #: STUDY22090018
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: Harikesh Subramanian, MBBS
• Phone: 412-647-2994
• Email: subramanianh4[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Electrolyte Depletion
• Electrolyte Imbalance
• Fluid and Electrolyte Imbalance

Intervention

Dietary Supplement:
• Buoy Electrolyte
Buoy intervention amount is 4% of total body weight given in 16 divided doses over 4 hours.
• Nuun
Nuun intervention given as 1L bolus and then free water in divided doses for a total of 4% total body weight.

Other:
• Water
Water serves as a control

Locations

Country	Name	City	State
United States	UPMC Montefiore Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net fluid balance	Determined by subtracting the cumulative urine output from the total fluid load consumed	Urine will be measured during each visit (three total visits that each last 6 hours)
Primary	Electrolytes in urine	Sodium, potassium, and chloride levels will be measured	Urine will be measured during each visit (three total visits that each last 6 hours)
Primary	Blood labs	Venous whole blood will be collected using phlebotomy and 100ul will be analyzed using an i-STAT.	Venous blood collection will occur at the screening visit and as necessary pending any changes to the patient's medical history and status.
Secondary	Bioimpedence	Bioimpedence measured after each urine collection	Each urine collection occurs for a total of 6 hours