The Impact of Buoy on Hydration Status of Active Men and Women
Phase: NA
Conditions: Dehydration, Electrolyte Imbalance, Electrolyte Depletion, Fluid and Electrolyte Imbalance
Sponsor: University of Pittsburgh

 
 
 
 
 
 
 
 
STUDY TITLE: The Impact of Buoy on Hydration Status of Active Men and Women 
IRB: STUDY22090018 
NCT05768789 
Study Protocol: 06 FEB 2024 
 

Date: Wednesday, December 11, 2024 2:34:11 PM
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View: Pitt SF: Basic Study Information 8.2
Basic Study Information
 
1. * Title of study:
The Impact of Buoy on Hydration Status of Active Men and Women
2. * Short title:
Buoy Electrolyte Study
3. * Brief description:
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.
4. * What kind of study is this?
Single-site study
 
5. * Will an external IRB act as the IRB of record for this study?
  Yes  No
6. * Local principal investigator:
Harikesh Subramanian
* Is this your first submission, as PI, to the Pitt IRB?
  Yes  No
7. * Does the local principal investigator have a financial interest related to this
research?
  Yes  No
8. Attach the protocol:
Sponsor/Multicenter/Investigator-initiated protocol
Coordinating Center supplement
Emergency Use Consent/ Protocol/ FDA Form 3926
Exempt Application form
 Document
Category
Date Modified
Document History
There are no items to display

View: Pitt SF: Funding Sources (not integrated with Grants)
Funding Sources
1. * Indicate all sources of support:
Internal funding
2. * Provide the source of your Internal funding:
Department of Anesthesiology and Perioperative Medicine  

View: Pitt SF: Study Team Members
Study Team Members
1. * Identify each person involved in the design, conduct, or reporting of the
research:
Name
Roles
Department/SchoolAffiliation
Involved
in
Consent
Qualifications
Financial
Interest
Cary Boyd
Co-
investigator
U of Pgh | School
of Medicine |
Medicine
UPP/UPMC
staff
yes
Dr. Cary Boyd,
MD, PhD is a
physician
scientist that is
specialized in
internal
medicine and
nephrology,
more specifically
renal-electrolyte.
Dr. Boy...
no
Kimberly
Howard-
Quijano
Co-
investigator
U of Pgh | School
of Medicine |
Anesthesiology
UPP/UPMC
staff
yes
Dr. Kimberly
Howard, MD is a
cardiac
anesthesiologist,
Director of
Translation
Research, and
the Associate
Vice Chair for
Research in the
Department ...
no
Amy Monroe
Key
Personnel /
Support
Staff
U of Pgh | School
of Medicine |
Anesthesiology
UPP/UPMC
staff
no
Amy Monroe is
the clinical trials
manager in the
Department of
Anesthesiology
and
Perioperative
Medicine and
will be the
administrative
support for t...
no
Evan Ray
Co-
investigator
U of Pgh | School
of Medicine |
Medicine
UPP/UPMC
staff
yes
Dr. Evan Ray,
MD, PhD is a
physician
specialized in
internal
medicine and
nephrology. Dr.
Ray has
published
extensively, and
therefore, will
advise t...
no
 view all 
 view all 
 view all 
 view all 

Name
Roles
Department/SchoolAffiliation
Involved
in
Consent
Qualifications
Financial
Interest
Kathirvel
Subramaniam
Co-
investigator
U of Pgh | School
of Medicine |
Anesthesiology
UPP/UPMC
staff
yes
Dr. Kathirvel
Subramaniam,
MD, is a clinical
cardiac
anesthesiologist
in the
Department of
Anesthesiology
and
Perioperative
Medicine. He is
also a wi...
no
Harikesh
Subramanian
Principal
InvestigatorOther
UPP/UPMC
staff
yes
Dr. Harikesh
Subramanian,
MBBS is a
cardiothoracic
and liver
transplantation
anesthesiologist
in the
Department of
Anesthesiology
and
Perioperative
M...
no
Nicole
Zharichenko
Key
Personnel /
Support
Staff
Other
UPP/UPMC
staff
no
Nicole
Zharichenko is
the ERAS
research
manager in the
Department of
Anesthesiology
and
Perioperative
Medicine.
no
2. External team member information: (Address all study team members in item
1. above and leave this section blank)
Name
Description
There are no items to display
3. Have you, Harikesh  Subramanian, verified that all members of the research
team have the appropriate expertise, credentials, training, and if applicable,
child clearances and/or hospital privileges to perform those research
procedures that are their responsibility as outlined in the IRB application?
*   Yes  No
 view all 
 view all 

View: Pitt SF: Study Scope 8.1
Study Scope
Check all that apply
1. * Will this study actively recruit any of the following populations?

Adults with impaired decision-making capacity

Children (under the applicable law of the jurisdiction in which the research will
be conducted (<18 years for PA))

Children who are Wards of the State

Employees of the University of Pittsburgh/UPMC

Medical Students of University of Pittsburgh as primary research group
Students of the University of Pittsburgh

Neonates of uncertain viability

Non-viable neonates

Non-English speakers

Nursing home patients in the state of Pennsylvania

Pregnant women

Prisoners

N/A
2. * Will any Waivers be requested?

Waiver/Alteration of Consent
Waiver to Document Consent

Waiver/Alteration of HIPAA

Exception from consent for emergency research

N/A
3. * Will this study involve any of the following?
Specimens

Honest Broker to provide data/specimens

Return of Results to Subjects or Others

Fetal tissue

N/A
4. * Will Protected Health Information be collected?

Pitt medical records
UPMC medical records

Other Institutions’ medical records

N/A
5. * Other Requests?

Deception (if not Exempt, also requires Waiver/Alteration of Consent)

Emergency Use / Single Patient Expanded Access (using FDA Form 3926)


Placebo Arm

Withdraw from usual care
N/A
6. * Determining Scientific Review:
Department Scientific Review (this option MUST be picked if there is DoD funding)
* Choose the appropriate organization to conduct the scientific review:
U of Pgh | School of Medicine | Anesthesiology
7. * Has this study (or substantially similar study) been previously disapproved
by the Pitt IRB or, to your knowledge, by any other IRB?
  Yes  No
Review the HRPO policy, if participating in research at the VA Pittsburgh Healthcare
System or using funding from the VA
8. * Does the study use an approved drug or biologic, use an unapproved drug
or biologic, or use a food or dietary supplement to prevent, diagnose, cure,
treat, or mitigate a disease or condition?
  Yes  No
9. * Does the study evaluate the safety or effectiveness of a device (includes in-
vitro laboratory assays)?
  Yes  No
10. * Is this application being submitted to convert an approved study from
OSIRIS to PittPRO? (Tip Sheet)
  Yes  No
 
11. * Does your research protocol involve the evaluation or use of procedures
that emit ionizing radiation and, after reviewing this HUSC guidance, does your
research protocol require HUSC review? (If yes, upload the HUSC form in the
Local Supporting Documents section). If you are unsure of review
requirement, select yes.
  Yes  No
 

View: Pitt SF: Research Sites
Research Sites 
1. Choose all sites that apply:
UPMC
* Select the UPMC sites where research will be conducted:
Montefiore
Presbyterian
2. Describe the availability of resources and the adequacy of the facilities to
conduct this study:
Study visits will take place in the same-day surgery center in Montefiore Hospital.
The study will be conducted on the weekend, ensuring that this space will be
available for use and will not interfere with regularly scheduled activities. The study
PI and coordinator will be available to run each study visit. Additionally, a
phlebotomist will be utilized to complete the blood draws.

View: Pitt SF: Local Site Documents
Click Continue as this page was intentionally left blank.

View: Pitt SF: Recruitment Methods
Recruitment Methods
* Will you be recruiting individuals for participation in this study?
  Yes  No
1. *  Describe who will be recruiting individuals for participation for this study:
The study team will be responsible for recruiting individuals for participation in this
study.
2. * Select all methods to be used for recruitment:
Flyers/Posters or Brochures
Pitt+Me
Other
*  Enter description of 'Other' method of recruiting:
Individuals will be recruited into this study through word of mouth. Potential subjects
recruited through word of mouth will be provided both an email address and phone
number to contact for study enrollment.
Study flyers will be posted around the University of Pittsburgh's campus. The study
flyers will be used to provide general information about the study and contact
information for potential participants to get in contact with the study team.
3. * Provide details on your recruitment methods:
Individuals from local colleges will be approached for recruitment into the study,
including the University of Pittsburgh School of Medicine, University of Pittsburgh,
and Duquesne University. These individuals will be recruited using word of mouth,
as detailed in the above response. Individuals will also be recruited through word-of-
mouth and Pitt+Me.
Students will not be required to participate in the research study and individual
students will not be specifically targeted. Potential participants will be solicited from
a "broad base" of individuals meeting the conditions for the study.
4. * Describe all compensation/incentives offered to participants and timing of
these offers:
Patients will be compensated $300 after completion of three visits. Payment will be
given on a reloadable Vincent debit card. The payment will not be separated by visit
but will instead be provided pending successful completion of the three study visits.
5. Recruitment materials: (attach all material to be seen or heard by subjects,
including advertisements and scripts)
 
Document
Category
Date
Modified
Document
History
View
Buoy
Recruitment
Flyer(2)
Recruitment
Materials
7/6/2023
History

View: Pitt SF: Study Aims
Study Aims
1. * Describe the purpose, specific aims, or objectives and state the hypotheses
to be tested:
The study aims include:
1. Evaluate if giving BUOY will decrease the total volume of urine excretion
2. Determine is BUOY will lead to bigger increase in Total Body Fluid
3. Determine if there are quantifiable differences between giving BUOY in divided
doses versus a bolus of NUUN
2. * Describe the relevant prior experience and gaps in current knowledge
including preliminary data. Provide for the scientific or scholarly background
for, rationale for, and significance of the research based on existing literature
and how it will add to existing knowledge:
Maintaining adequate hydration is essential to optimal health [1,2,3] and athletic
performance [4,5]. Dehydration can contribute to a host of issues, including altered
cognition and digestion, as well as organ dysfunction in the heart, kidneys, and skin
[3]. When individuals exercise (particularly in a warm environment), they can lose
excessive amounts of fluids through sweating, along with necessary electrolytes
(e.g., sodium, potassium, chloride) [5,6]. With dehydration, athletes may feel
sluggish and physical performance can suffer [7,8].
Many attempts have been made to improve the hydration status of active individuals
[7,8,9,10]. According to the American College of Sports Medicine’s position stand,
fluids containing sodium should be slowly ingested leading up to activity to help
retain fluids, so that athletes maintain euhydration with normal electrolyte levels [6].
Hydration strategies during physical activity should be aimed at preventing fluid loss
greater than 2% of the body weight, which can be optimally accomplished by
ingesting a diluted carbohydrate/electrolyte beverage at a rate approximately
equivalent to sweat loss. During recovery, enough water and food containing sodium
should be ingested to replenish electrolyte losses and reestablish euhydration [6].
This approach seems to work well. However, some debate remains over what the
best fluid is to consume, particularly with respect to macronutrient type and the
specific electrolyte mix.
Related to the above, it is well-accepted that electrolyte replenishment is of
importance both during and following exercise, to aid in rehydration for subsequent
exercise bouts [6,11]. Electrolytes (sodium in particular) have been used for decades
to aid athlete hydration, and this has led to the development of various sport drinks
—which also often include moderate amounts of carbohydrate (e.g., Gatorade®
(PepsiCo; Chicago, IL, USA) and Powerade® (The Coca-cola Company; Austin, TX,
USA)). However, one problem with carbohydrate ingestion is that some individuals
experience gastrointestinal (GI) upset following carbohydrate ingestion before [12]
and during an event [13], despite very good physical performance outcomes. Due to
this GI upset, some individuals (in particular, recreationally active individuals who
are not competing at high levels) rely solely on water and seek a method to ingest
the lost electrolytes. In addition, some individuals prefer to have both plain water
and an electrolyte beverage during their training/competition sessions, and in some
activities (e.g., running and cycling), carrying multiple bottles of fluid is difficult.

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.
1. Perrier E.T. Shifting Focus: From Hydration for Performance to Hydration for
Health. Ann. Nutr. Metab. 2017;70:4–12. doi: 10.1159/000462996. [PubMed]
[CrossRef] [Google Scholar]
2. Liska D., Mah E., Brisbois T., Barrios P.L., Baker L.B., Spriet L.L. Narrative
Review of Hydration and Selected Health Outcomes in the General Population.
Nutrients. 2019;11:70. doi: 10.3390/nu11010070. [PMC free article] [PubMed]
[CrossRef] [Google Scholar]
3. Popkin B.M., D’Anci K.E., Rosenberg I.H. Water, hydration, and health. Nutr. Rev.
2010;68:439–458. doi: 10.1111/j.1753-4887.2010.00304.x. [PMC free article]
[PubMed] [CrossRef] [Google Scholar]
4. Nuccio R.P., Barnes K.A., Carter J.M., Baker L.B. Fluid Balance in Team Sport
Athletes and the Effect of Hypohydration on Cognitive, Technical, and Physical
Performance. Sports Med. 2017;47:1951–1982. doi: 10.1007/s40279-017-0738-7.
[PMC free article] [PubMed] [CrossRef] [Google Scholar]
5. Von Duvillard S.P., Braun W.A., Markofski M., Beneke R., Leithäuser R. Fluids
and hydration in prolonged endurance performance. Nutrition. 2004;20:651–656.
doi: 10.1016/j.nut.2004.04.011. [PubMed] [CrossRef] [Google Scholar]
6. Sawka M.N., Burke L.M., Eichner E.R., Maughan R.J., Montain S.J., Stachenfeld
N.S. Exercise and Fluid Replacement. Med. Sci. Sports Exerc. 2007;39:377–390.
doi: 10.1249/mss.0b013e31802ca597. [PubMed] [CrossRef] [Google Scholar]
7. Lee E.C., Fragala M.S., Kavouras S.A., Queen R.M., Pryor J.L., Casa D.J.
Biomarkers in Sports and Exercise: Tracking Health, Performance, and Recovery in
Athletes. J. Strength Cond. Res. 2017;31:2920–2937. doi:
10.1519/JSC.0000000000002122. [PMC free article] [PubMed] [CrossRef] [Google
Scholar]
8. Kenefick R.W. Drinking Strategies: Planned Drinking Versus Drinking to Thirst.
Sports Med. 2018;48:31–37. doi: 10.1007/s40279-017-0844-6. [PMC free article]
[PubMed] [CrossRef] [Google Scholar]
9. Love T.D., Baker D.F., Healey P., Black K.E. Measured and perceived indices of
fluid balance in professional athletes. The use and impact of hydration assessment
strategies. Eur. J. Sport Sci. 2018;18:349–356. doi:
10.1080/17461391.2017.1418910. [PubMed] [CrossRef] [Google Scholar]
10. Maughan R.J., Shirreffs S.M. Development of hydration strategies to optimize
performance for athletes in high-intensity sports and in sports with repeated intense
efforts: Development of hydration strategies to optimize performance for athletes.
Scand. J. Med. Sci. Sports. 2010;20:59–69. doi: 10.1111/j.1600-0838.2010.01191.x.
[PubMed] [CrossRef] [Google Scholar]
11. Evans G.H., James L.J., Shirreffs S.M., Maughan R.J. Optimizing the restoration
and maintenance of fluid balance after exercise-induced dehydration. J. Appl.
Physiol. 2017;122:945–951. doi: 10.1152/japplphysiol.00745.2016. [PubMed]
[CrossRef] [Google Scholar]
12. 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. PMID: 33023276; PMCID: PMC7600513.
13. 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. PMID: 26702122.
 

View: Pitt SF: Study Design
Study Design
1. Total number of subjects to be enrolled at this site (enter -1 for chart reviews,
banking, registries):
34
2. Describe and explain the study design:
The proposed study will be conducted as a single-center prospective, cross-over,
placebo-controlled clinical trial at the University of Pittsburgh Medical Center
(UPMC).
3. Describe the primary and secondary study endpoints:
Urine volume (collected each visit over 6-hour time frame)
Electrolytes: sodium, potassium, chloride
Urine osmolarity
Urine creatinine
4. Provide a description of the following study timelines:
Duration of an individual subject's active participation:
The individual's active participation will involve three separate sessions, each lasting
approximately 6 hours (total of 18 hours for each participant).
Study visits will be completed within a three-to-four month period.
Duration anticipated to enroll all subjects:
Approximately 9 months
Estimated date for the investigator to complete this study (complete primary
analyses): 
4/1/2024
5. List the 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

6. List the 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.
7. Will children or any gender, racial or ethnic subgroups be explicitly excluded
from participation?
  Yes  No
* Identify the subgroups and provide a justification: 
Children will be excluded from participation since the study is looking at the
hydration status of active adults.
8. Describe the power analysis used and cite your method of statistical analysis.
If a power analysis is not possible, thoroughly justify the sample size required
for the study, including appropriate literature citation (alternatively provide
page reference in attached protocol):
The data will be presented as mean ± SD, analyzed using the conditions x time
analysis of variance (ANOVA), while BHI will be analyzed using a one-way ANOVA.
Tukey post-hoc testing and contrast analysis can be used as appropriate. Statistical
significance was set at p ≤ 0.05.
We aim to have 30 subjects complete the study. This is a pilot study to inform a
future large-scale trial with appropriate power calculation.

View: Pitt SF: Research Activities
Research Activities
1. * Provide a detailed description of all research activities (including screening
and follow-up procedures) that will be performed for the purpose of this
research study. This description of activities should be complete and of
sufficient detail to permit an assessment of associated risks.
Prior to initiation of the study, subjects will complete a brief phone screen to assess
basic eligibility and will be asked to fast. The screening visit will consist of informed
consent, health history, and discussing eligibility requirements for each study visit,
including (1) refrain from vigorous exercise for 24 hrs prior, (2) fast overnight for at
least 10 hrs, (3) empty bowel and bladder upon waking up, (4) can consume one
8oz cup of coffee or tea. For female subjects, this will also include their last date for
menstruation and/or birth control method to take into consideration the effects of
ovulation on water retention.
Prior to all research visits (screening, visits 1, 2, and 3), participants must refrain
from vigorous exercise (exercises that results in a high heart rate and rapid
breathing) 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 and
bladder. They can consume one 8oz cup of coffee or tea (plain with no sugar or
additives) to reduce caffeine headaches. They will present at 7-8am, which will be
pre-specified. Prior to emptying their bladder, a blood draw of up to 1 ml will be
drawn by a trained phlebotomist for the i-STAT testing, which will be used to
measure creatine and electrolytes. After this they will be asked to empty their
bladder. Immediately after emptying the bladder, bioimpedence will be measured.
Females will be administered a urine pregnancy test. A urinalysis dipstick for
protein/blood/glucose and i-STAT measurement for creatinine and electrolytes will
be completed to confirm eligibility. Next, the subject will be asked to rest for 5 mins,
after which baseline vitals will be taken, including blood pressure, heart rate, weight.
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. 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.
Additional food or beverage will not be allowed throughout the study period.
VISIT 1---BUOY INTERVENTION: 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 4
tsps (18 ml) of Buoy diluted in 1 L of water.
Prior to initiation of test blood pressure and heart rate will be measured. Urine will be
collected and discarded.

At time 0, the participant will begin to drink fluid (drinking 6.25% of their total amount
every 15 min). Urine will be collected at 60, 120, 240, and 360 min. Bioimpedence
will be measured after each urine collection. Collect urine for a total of 6 hours.
VISIT 2—WATER CONTROL: Participants will ingest 1 L of water at a rate of 6.25%
of the calculated amount of water every 15 min for 4 hours.
Prior to initiation of test blood pressure and heart rate will be measured. Urine will be
collected and discarded.
At time 0, the participant will begin to drink fluid (drinking 6.25% of their total
calculated amount every 15 min). Urine will be collected at 60, 120, 240, and 360
min. Bioimpedence will be measured after each urine collection. Collect urine for a
total of 6 hours.
VISIT 3—NUUN INTERVENTION: The goal is to give a one-time dose of 2 tablets of
Nuun Sport (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).
Prior to initiation of test blood pressure and heart rate will be measured. Urine will be
collected and discarded.
At time 0, the participant will consume the beverage over 30 min. Urine will be
collected at 60, 120, 240, and 360. Bioimpedence will be measured after each urine
collection. Collect urine for a total of 6 hours. Patients will be compensated $300
after completion of three visits.
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. Nuun are electrolyte tablets that are added to water to
improve fluid balance and beverage hydration index (BHI) in healthy individuals
(Pence, 2020). Nuun tablets contain a mix of electrolytes, including calcium,
magnesium (as an oxide), chloride, sodium, and potassium. The recommended use
of Nuun is one tablet dissolved in water, administered once daily.
The PI and study team will be performing the research procedures. A phlebotomist
will be used to complete the blood draws.
Following each study visit, a boxed lunch will be offered to each participant. This
lunch will be Jimmy John's (or a similar sandwich shop). Each participant will be
asked about preferences and food allergies during the screening process so provide
an appropriate option for participants involved.
2. Upload a copy of all materials used to collect data about subjects: (Attach all
surveys, interview/focus group scripts, and data collection forms except for
case report forms, SCID or KSADS):
 
Document
Category
Date Modified Document History
View Buoy Patient Data Sheet(1) Data Collection 7/6/2023
History
3. * Will blood samples be obtained for research purposes?
  Yes  No
* Provide the volume per withdrawal, total volume and frequency,
and qualifications of individual performing the procedure:

Venous whole blood will be collected using phlebotomy and up to 1 ml will be
collected to be analyzed using an i-STAT. Blood will be collected for i-STAT analysis
during the screening visit. 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
blood test to confirm eligibility.
Blood will be drawn by a trained phlebotomist.
 

View: Pitt SF: Consent Process
Consent Process
Enter N/A in response to the following questions if a Waiver of Consent is requested for all
research activities or if no subjects are being enrolled.
1. * Indicate where the consent process will take place and at what point
consent will be obtained:
The consent process will take place prior to the initiation of study procedures.
eConsent will be collected prior to the screening visit and Visit 1 in order to minimize
the time spent by each participant during the first visit. eConsent will be collected
using Pitt RedCap. eConsent will be signed via stylus, fingertip, or mouse.
2. * Describe the steps that will be taken to minimize coercion and undue
influence, including assurance that there is sufficient time for subjects to
make an informed decision:
In order to minimize the possibility of coercion or undue influence, the participants
will first be informed that their choice of participation in the study is completely
voluntary in nature. Prospective participants will be encouraged to ask questions
and to discuss the study with others during the consent process. All of the
participants questions will be addressed. It will be made clear that the participant
may withdraw from the study at any time.
eConsent will be completed over the phone. An electronic copy will be provided to
participants at the time of eConsent.
3. For studies that involve multiple visits, describe the process to ensure
ongoing consent:
Individuals will be reminded that their participation in the study is voluntary and that
they can withdraw at any time during each visit.
Consent will be re-affirmed prior to each ensuing study visit.
4. * Steps to be taken to ensure the subjects’ understanding:
Individuals will be provided with a full explanation of the study-related goals and
procedures. Questions will be answered from the participant. Participants will be
given as much time as necessary to read the consent form and ask questions.
Consent will be obtained by the study PI, Co-investigator, or study coordinator.
5. * Are you requesting an exception to the IRB policy related to the informed
consent process:
  Yes  No
* Provide a justification and describe the qualifications of the individuals who
will obtain consent:
This is a minimal risk study and we are requesting that Nicole Zharichenko be
permitted to conduct the informed consent process. Nicole Zharichenko has

extensive experience and training in conducting informed consent for these types of
studies.

View: Pitt SF: Consent Forms
Consent Forms 
1. Consent Forms:
 
Document
Category
Date Modified Document History
View Buoy Consent Form (4.04)
Consent Form 2/5/2024
History
Refer to the following templates and instructional documents:
Guidance - Consent Wording
Template - Consent Document - Short Form
HRP-090 - SOP - Informed Consent Process for Research  
HRP-091 - SOP - Written Documentation of Consent  
 

View: Pitt SF: Waiver to Document Informed Consent
Waiver to Document Informed Consent
This waiver to document informed consent can be requested for any or all participants, for any
or all procedures (e.g., a verbal or computerized consent script will be used, but the subjects
will not be required to sign a written informed consent document, such as with phone
screening).
1. * Identify the specific research procedures and/or the specific subject
populations for which you are requesting a waiver of the requirement to obtain
a signed consent form:
Phone screen to determine subject eligibility and ask permission to fast.
2. * Select the regulatory criteria applicable to your request:

45 CFR 46.117(c)(1) That the only record linking the subject and the research
would be the consent document and the principal risk would be potential harm
resulting from a breach of confidentiality. Each subject will be asked whether
the subject wants documentation linking the subject with the research, and the
subject's wishes will govern.

45 CFR 46.117(c)(2) That the research presents no more than minimal risk of
harm to subjects and involves no procedures for which written consent is
normally required outside of the research context

45 CFR 46.117(c)(3) If the subjects or legally authorized representatives are
members of a distinct cultural group or community in which signing forms is not
the norm.
* Address why the specific research procedures for which you are requesting
a waiver of the requirement to obtain a signed consent form presents no more
than minimal risk of harm to the research subjects:
The specific research procedure for which we are requesting a waiver of signed
consent consists of permission to fast for the first visit. The potential risks are
feelings of hunger, dizziness, and headaches, which are considered minimal.
* Justify why the research involves no procedures for which written informed
consent is normally required outside of the research context:
The only research activity is asking subjects to fast. Patients are normally asked to
fast for clinical care procedures that would not normally require written consent.
3. * Upload Scripts:
 
Document
Category
Date Modified Document History
View Phone Screening Script(2)
Waiver Script 1/23/2024
History

View: Pitt SF: Medical Records
Medical Records
1. You are required to submit this study to the Research Informatics Office, Health
Record Research Request (R3). Per UPMC Policy HS-RS0005, all research
projects that access or involve UPMC electronic protected health information (e-
PHI) must be submitted to R3, with the exception of clinical trials that are
contracted through the UPMC Office of Sponsored Programs and Research
Support (OSPARS).
Complete the R3 intake form available at http://rio.pitt.edu/services. An R3
representative will conduct a review. You will be notified once your R3 review is
complete or if anything further is needed.
* Describe the protected health information that will be collected from the
covered entity and/or the research derived information that will be placed into
the medical records:
The information that will be recorded will include lab results, both from blood and
urinalysis, medical history, and patient demographics including: name, age, MRN,
race, gender, and date of birth
This research study will result in identifiable information that will be placed into
patient medical records held at UPMC. Information placed in patient's medical
records will include the urine electrolytes and urine creatinine. Testing placed in the
medical records will be completed at a CLIA certified UPMC lab.

View: Pitt SF: Electronic Data Management
Electronic Data Management
1. * Will only anonymous data be collected (select NO if identifiers will be
recorded at anytime during the conduct of the study)?
  Yes  No
Select all identifiers to be collected during any phase of the research including
screening:
Name:

E-mail address:

Social security #:

Phone/Fax #:

Account #:

Medical record #:

Certificate/license #: 
 
 
Internet Protocol (IP) Address:

Web Universal Resource Locators (URLs):

Social security # (for Vincent payment only):

Full face photo images or comparable images: 
Health plan beneficiary #:

Device identifiers/serial numbers:

Vehicle identifiers/serial #/license plate #:

Biometric identifiers, finger and voice prints:

* 
a: Will you be collecting any of the following location data: geographic subdivisions smaller
than a State such as street address, city, county, precinct, zip, geocodes, etc.?
 
  Yes  No
* b: Will you be collecting any date information such as birth date, death, admission,
discharge, date of surgery/service?
  Yes  No
c: List any other unique identifying numbers, characteristics or codes related to an
individual that are to be collected:
All data will be
coded with a
participant's
unique study ID
and de-
identified
d: Will you be collecting any data subject to the General Data Protection Regulation (GDPR)?   Yes  No
* e: Provide a justification for recording Social Security numbers including why it's required,
where it's stored, how it's protected and who will have access:
Social security
numbers will be
collected for
payment
purposes only.
Social security
number will be
destroyed once
entered in the
Vincent
system.
* 
For ALL identifiable data collected, will you
be coding the data by removing the
identifiers and assigning a unique study
ID/code to protect the identity of the
participant?
  Yes  No
* Will the data be HIPAA de-identified?
  Yes  No
* Briefly describe your plan to store coded
data separately from the identifiable data:
Data collected will be managed
by the research study team and
stored in a manner that
maintains patient confidentiality.
Identifiable data will be stored in

a separate password-protected
file on the UPMC server and will
be kept separate from the main
de-identified data set.
2. During this study, will restricted data as defined by the University’s Data Risk
Classification matrix ( https://www.technology.pitt.edu/security/data-risk-
classification-and-compliance ) be processed, stored, or transmitted?
  Yes  No 
3. * During this study, will sensitive data (https://www.hrpo.pitt.edu/electronic-data-
security) be collected where disclosure of identifying information could have
adverse consequences for subjects or damage their financial standing,
employability, insurability, educational advancement, reputation or place them
at risk for criminal or civil liability?
  Yes  No
4. * Select all locations where data will be stored or archived(including e.g.,
personal / employer laptop or desktop): If you have access to University owned
or controlled resources, facilities, or repositories, such as computer servers,
please choose that option to comply with the Research Data Management
Interim Policy R1 14.
Please note that to address Research Security Requirements, University data
must be stored in University owned, controlled, or approved repositories,
such as Pitt OneDrive. If UPMC or external electronic repositories must be
used, they must be approved by Pitt IT.
 
Storage Device
DescriptionIdentifiable
Data
Sensitive
Data
De-
Identified/Anonymous
Data
View
UPMC:
Departmental or
Hospital Server 
 
yes
yes
yes
View
UPMC owned
desktop, laptop or
other device
 
no
no
no
5. * Select all technologies being used to collect data or interact with
subjects: Technologies selected in this section may require a Vendor Security
Risk Assessment, which can be requested here.
Web-based site, survey, or other tool
N/A
6. * Web Based Technologies – identify all web based technologies to be used to
collect data during any phase of the research:
 
name
Identifiable
View Pitt Redcap Version
 

View: Pitt SF: Data Safety and Monitoring
Data Safety and Monitoring
1. * Describe your plan to periodically evaluate the data collected regarding both
harms and benefits to determine whether subjects remain safe.  The plan
might include establishing a data monitoring committee and a plan for
reporting data monitoring committee findings to the IRB and the sponsor:
The following data and safety monitoring plan will be instituted to ensure the safety
of the subjects and to maintain the confidentiality of the research data. The
investigators and study coordinators will perform a monthly review of the accrued
data, including adverse events, unanticipated problems and subject withdrawals, to
ensure the validity and integrity of the data and to reassess the benefit-to-risk ratio
on a frequent and regular basis. Subject privacy and research data confidentiality
will be ensured by reviewing the adequacy of the secure location of where the data
is stored and by making sure it is all de-identified with the coded case numbers as
described previously. The results from the data and safety monitoring will be
forwarded to the Institutional Review Board at least yearly or during annual review.
2.   * Describe your plan for sharing data and/or specimens:
De-identified data may be shared with others inside and outside of the University
who are conducting similar research. Though, at this time, there is no plan to share
data with outside universities.
An appropriate sharing agreement will be completed prior to sharing.
3. If any research data is collected, stored, or shared in a paper format, address
what precautions will be used to maintain the confidentiality of the data:
Any data collected, stored, or shared in a paper format will be kept in a locked file
cabinet, with access only provided to study members.

View: Pitt SF: Data and Specimens
Specimens and Related Data
1. * Data and Specimens will be stored:
Limited time (i.e., only until the study is completed)
2. * Indicate the type of specimen, describe where stored, and for how long:
Blood and urine specimens will be collected during this study. The specimens will
only be used to obtain test results, including electrolytes, creatinine, protein, and
glucose, and will be discarded after results are obtained.
3. * How the specimens will be accessed and who will have access to the
specimens:
All specimens will be sent to the UPMC lab. None will be stored by the study team.
4. * List the data to be stored or associated with each specimen:
All specimens will be sent to the UPMC lab. None will be stored by the study team.
5. * Describe the procedures to release data or specimens, including the
process to request a release, who can obtain data or specimens, the data to
be provided with the specimens:
The data will be released to the study team upon testing of the specimens.

View: Pitt SF: Risk and Benefits
Risk and Benefits
1. *  Enter all reasonably foreseeable risks, discomforts, hazards, or
inconveniences to the subjects related to subjects’ participation in the
research:
View
Research Activity
Blood draw 
Common Risks
Hematoma, bruising  
Infrequent Risks
Fainting  
Other Risks
No Value Entered 
View
Research Activity
Nuun 
Common Risks
No Value Entered 
Infrequent Risks
Nausea, dislike of taste 
Other Risks
No Value Entered 
View
Research Activity
Ingestion of water  
Common Risks
No Value Entered 
Infrequent Risks
Water intoxication can occur if consuming 4-5 L of water in a few hours,
symptoms include headache, cramping weakness, nausea, vomiting,
drowsiness and fatigue.  
Other Risks
No Value Entered 
View
Research Activity
Buoy 
Common Risks
No Value Entered 
Infrequent Risks
Nausea, dislike of taste  
Other Risks
No Value Entered 
View
Research Activity
Collection and storage of private health information  
Common Risks
No Value Entered 
Infrequent Risks
Risk of breach of confidentiality  
Other Risks
No Value Entered 
View
Research Activity
Fasting 
Common Risks
Headache, dizziness, hunger  
Infrequent Risks
Fainting  
Other Risks
No Value Entered 

2. *  Describe the steps that will be taken to prevent or to minimize risks:
To avoid water intoxication, we will limit free water intake to no more than 2.5 L per
testing day (PMID 12053855).
All data will be stored with a unique ID and will be kept on a secure server or in
locked filing cabinet in a secure office.
Subjects will be encouraged to bring a snack with them to eat after the completion of
fasting.
3. Financial risks - will the subject or insurer be charged for any research
required procedures?
  Yes  No
4. Describe the steps that will be taken to protect subjects’ privacy:
All research interventions will be conducted in a private exam room. Collection of
sensitive information about subjects is limited to the amount necessary to achieve
the aims of the study.
5. What steps will be taken in the event that a clinically significant, unexpected
disease or condition is identified during the conduct of the study:
Should a clinically significant, unexpected disease or condition be identified during
the conduct of the study, the patient's primary medical team will be immediately
notified of the unexpected, clinically significant condition. The patient's clinically
significant medical condition will be managed accordingly. If any of the clinically
significant medical conditions is related to the study, then the patient's participation
in the study will be re-evaluated, with the possibility of the patient being withdrawn
from the study if it leads to the resolution of the clinically significant medical
condition.
6. Describe the potential benefit that individual subjects may experience from
taking part in the research or indicate if there is no direct benefit. Do not
include benefits to society or others:
Participation in the research does not offer direct benefit to the research subjects.
7. Do you anticipate any circumstances under which subjects might be
withdrawn from the research without their consent?
  Yes  No
8. Describe procedures that will be followed when subjects withdraw from the
research, including partial withdrawal from procedures with continued data
collection and data already collected:
Any identifiable research or medical information recorded for, or resulting from,
participation in the research study prior to the date of withdrawal may continue to be
used and disclosed by the investigator for the purposes of research. Data will
continue to be stored on secure servers and de-identified prior to analysis.

View: Pitt SF: Conflict of Interest Ver2
Conflict of Interest
Institutional Financial Interests
1. * To the best of your knowledge, has the University of Pittsburgh optioned or
licensed technology that will be tested or evaluated in this research?
  Yes  No

View: Pitt SF: Ancillary Reviews
Ancillary Reviews 
1. Ancillary reviews or notifications selected below are required based on
previous answers to questions. If a selection is incorrect, return to the
appropriate page and adjust the answers to questions on that page: 
  Conflict of Interest (COI)
  Clinical and Translational Research Center (CTRC)
  Data Security
  Honest Broker
  UPMC Investigational Drug Service
  Pitt Medical School Review
 Pitt+Me  
  IND & IDE Support(IIS)
  Radioactive Drug Research Committee (RDRC)(study involves the evaluation
or use of procedures that emit ionizing radiation)
  ORP Business Manager (required for industry sponsored studies)
  Religious Directives
  Scientific Review
  Health Record Research Request (R3) (required if using UPMC clinical data
and authorization for other UPMC data sources for research)
  UPMC Office of Sponsored Programs and Research Support (using UPMC
facilities and/or UPMC patients during the conduct of the study)
2. Additional ancillary reviews the PI may choose to include as needed for the
research:
  Human Stem Cell Oversight (hSCRO)
  Institutional Biosafety Committee (IBC)(study involves deliberate transfer of
recombinant or synthetic nucleic acid molecules)

View: Pitt SF: Clinical Trials
Good Clinical Practice (GCP) Training
1. * Regardless of funding source, is this study a clinical trial (as defined by the
NIH)?
  Yes  No
ClinicalTrials.gov Information
Visit the University of Pittsburgh Office for ClinicalTrials.gov website or contact ctgov@pitt.edu
for further information.  
2. * Was this study registered, or will it be registered, on ClinicalTrials.gov?
  Yes  No
3. * Is the University of Pittsburgh or UPMC the Sponsor Organization for this
study record?
  Yes  No 
* Who will be the Responsible Party for this study record?
Principal Investigator of this IRB application

View: Pitt SF: Supporting Documents
Supporting Documents
1. Attach any additional supporting documents not previously uploaded. Name
the documents as you want them to appear in the approval letter:
 Document
Category
Date Modified
Document History
There are no items to display

View: Pitt Create
Add Storage Information
1. * Select a Storage Type:
UPMC: Departmental or Hospital Server 
2. Description:
3. * Will identifiable data be stored in this location?
  Yes  No
4. * Will sensitive data be stored in this location?
  Yes  No
5. Will de-Identified or anonymous data be stored in this location?
  Yes  No
6. Provide additional information as needed:

View: Pitt Create
Add Storage Information
1. * Select a Storage Type:
UPMC owned desktop, laptop or other device
2. Description:
3. * Will identifiable data be stored in this location?
  Yes  No
4. * Will sensitive data be stored in this location?
  Yes  No
5. Will de-Identified or anonymous data be stored in this location?
  Yes  No
6. * Is anti-virus software installed and up to date on all devices and are the
operating systems kept up-to-date on all devices?
  Yes  No
7. Provide additional information as needed:

View: Pitt Risk
Risk
1. * Research Activity:
Blood draw
2. Common Risks:
Hematoma, bruising
3. Infrequent Risks:
Fainting
4. Other Risks:

View: Pitt Risk
Risk
1. * Research Activity:
Nuun
2. Common Risks:
3. Infrequent Risks:
Nausea, dislike of taste
4. Other Risks:

View: Pitt Risk
Risk
1. * Research Activity:
Ingestion of water
2. Common Risks:
3. Infrequent Risks:
Water intoxication can occur if consuming 4-5 L of water in a few hours, symptoms
include headache, cramping weakness, nausea, vomiting, drowsiness and fatigue.
4. Other Risks:

View: Pitt Risk
Risk
1. * Research Activity:
Buoy
2. Common Risks:
3. Infrequent Risks:
Nausea, dislike of taste
4. Other Risks:

View: Pitt Risk
Risk
1. * Research Activity:
Collection and storage of private health information
2. Common Risks:
3. Infrequent Risks:
Risk of breach of confidentiality
4. Other Risks:

View: Pitt Risk
Risk
1. * Research Activity:
Fasting
2. Common Risks:
Headache, dizziness, hunger
3. Infrequent Risks:
Fainting
4. Other Risks: