Consent Form for Participation in a Research Study
Co-Principal Investigators: Carl Maresh, Ph.D.,
Student Researcher: Brandon Yates, B.S.
Study Title: The Effects of Hydrothermal Modified Starch on Intermittent Performance.
Introduction
You are invited to participate in a research study to examine the effects of hydrothermal modified starch (HMS)
on physical performance and macronutrient metabolism during intermittent high-intensity exercise similar to
many common competitive sports.
You are being asked to participate because you are an individual who exercises 4- 6 times a week and are a
recreational athlete. Your participation in this study to your fullest ability is integral to its overall success.
This consent form will give you the information you will need to understand why this study is being done and
why you are being invited to participate. It will also describe what you will need to do to participate and any
known risks, inconveniences or discomforts that you may have while participating. We encourage you to take
some time to think this over and to discuss it with your family, friends and doctor. We also encourage you to
ask questions now and at any time. If you decide to participate, you will be asked to sign this form and it will be
a record of your agreement to participate. You will be given a copy of this form.
Why is this study being done?
The purpose of this study is to examine the effects of hydrothermal modified starch (HMS) on physical
performance and macronutrient metabolism during exercise during intermittent high-intensity exercise similar to
many common competitive sports but most specifically soccer. HMS supplementation will be compared to a
standard carbohydrate sports drink already being utilized by competitive athletes.
The goal of the investigation is to determine if a HMS drink supplement can be utilized to provide an ergogenic
benefit for competitive athletes participating in intermittent sports. The information gained herein can be
utilized in performance and clinical settings to optimally prescribe training programs and nutritional
interventions.
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What are the study procedures? What will I be asked to do?
You will complete 4 lab visits consisting of a baseline, familiarization, and 2 experimental testing visits. The
entire project will last 3-4 weeks depending on your availability. Throughout this time you will consume a
eucaloric (weight maintenance) diet. Investigators will monitor your diet via 3-day diet records, which you will
bring in weekly. This will enable protein and fat intakes to be held constant (1.5 g∙kg-1∙d-1 protein, dietary fat
approximating 30% of total energy). Protein intake is set at a level within the range of the current Dietary
Recommended Intake (DRI) which is in excess of the recommended daily allowance (RDA) (0.8 g∙kg-1∙d-1) but
consistent with protein intake for physically active individuals. You will be counseled by investigators to
maintain a consistent diet throughout the course of the study. You will keep your own food records in a
personalized food diary notebook, which will be provided. To ensure complete and accurate recording of food
intake, you will receive "reminder" phone calls, positive reinforcement, and random 24 hour recalls will be
conducted once weekly as well as to validate nutrient data from food records. Finally, body weight will be
measured and reported weekly for weight maintenance for the duration of the study. If necessary, energy intake
will be adjusted to accommodate energy balance and a stable body weight for participants.
After enrolling in the study you will undergo one morning of baseline testing. First, height and weight will be
measured. Next, body composition will be determined using a three-site skinfold measurement at the chest,
abdomen, and anterior thigh. During this time you will also be fitted with a telemetry strap to measure heart rate
during the exercise portion of this protocol. Finally, you will complete a graded exercise test to measure
maximal oxygen consumption.
Next, you will be familiarized with the exercise protocol by completing two 45-minute segment of a soccer
specific metabolic simulation on a treadmill. The protocol consisting of the various exercise intensities that are
regularly observed during competitive soccer matches (i.e. walking, jogging, cruising, and sprinting). The
proportion of time for each activity is as follows: static 3.87% walking 27.89%; jogging 38.85%; cruising
19.92%; sprinting 9.47%. Next, you will complete 10 consecutive vertical jumps utilizing a force plate to
measure power and height during these jumps will be measured with a VerTex. Lastly, you will complete a
300yd shuttle test on an AstroTurf indoor football field with incremental marker cones and lines placed 10 yards
apart to indicate the sprint distance. You will start with a foot on one line then when instructed by the timer, run
to the opposite 10-yard line, touch it with your foot, turn and run back to the start. This is repeated six times
without stopping (covering 300 yards total) while increasing the sprint distance by 10 yards upon every return to
start. The test is complete after the 50-yard line is reached and you return back to start.
You will then undergo the monitored soccer specific metabolic simulation consuming a carbohydrate beverage
prior to and during exercise in a randomized controlled order. On each testing day you will report to the Mark R.
Shenkman Training Center at approximately the same time each test day, after consuming a pre-trial meal
approximately 3 hours prior consisting of a plain bagel, banana, and peanut butter. Following a 50g bolus of
supplementation (-30min), you will then perform a dynamic warm-up followed by a 5-minute warm-up at 4.0
mph on a treadmill (walking speed). Next, you will complete the first 45-min metabolic soccer game simulation
on a treadmill varying intensity from 45%-100% VO2peak. Then you will rest for 5 minutes before performing a
5 minute steady state treadmill run estimated to elicit effort equal to 60% VO2peak, as determined during baseline
testing on the treadmill. A second 50g bolus of the appropriate supplement will be consumed (~60min) prior to
the start of the 2nd 45-minute metabolic soccer game simulation. At the completion of the 2nd 45min metabolic
soccer game simulation another 5 minute steady state running test will be performed to elicit effort equal to 60%
VO2peak, followed by10 vertical jumps, and a 300yd shuttle run. Between all performance measures, you will rest
for 5 minutes. Lastly, fluid consumption throughout entire protocol will be ad libitum. Fluid will be attached to
the treadmill in a bottle during entire protocol.
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Blood lactate and blood glucose will be measured via finger stick. A trained and HPL approved researcher will
perform the finger stick and sterile procedures will be used to reduce the risk of infection. Finger sticks will be
conducted 6 times during the metabolic simulation at minutes 15,30,45,75,90, and 105. A total of
approximately (12) finger sticks will conducted over the course of the research protocol totaling less than 1 ml
of blood needed for the entire protocol.
PROTOCOL SCHEMATIC
45-Minute
Metabolic
Simulation
45-Minute
Metabolic
Simulation
5-min ST
5-min ST
VJ
300YD
-30
0
15
-180
MEAL
30
45
50
75
90
105
110
60
LEGEND:
ST= STEADY STATE
VJ= VERTICAL JUMPS
300YD= SHUTTLE RUN
= SUPPLEMENT
= FINGER PRICK
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What are the risks or inconveniences of the study?
The composite of risks involved with the attached protocol are minimal. You will undergo VO2max
testing which involves running on a treadmill until you can no longer continue. The American College
of Sports Medicine (ACSM) has listed the risk associated with this testing procedure to be minimal when
working with trained individuals under the age of 34. Additionally in order to prevent any injuries due
to running on the treadmill all you will be instructed on how to properly start and stop exercise upon
conclusion. Trained graduate students with experience administering these tests will oversee all max
tests.
Common risks of finger sticks include mild discomfort, bleeding, and bruising. An infrequent risk is infection.
To attenuate these risks, an aseptic technique will be performed to minimize infection and direct pressure will be
applied to minimize bleeding and bruising.
You may become sore or injured due to running. Therefore, any risk of injury due to running is not increased by
participation in this study. There are no known risks or discomforts associated with measurements of body
weight, skin folds, or heart rate.
Inconveniences from the above protocol are due to time. In sum, you will be required to perform 1
metabolic game simulation at variable intensities (90 min at 45%-100% VO2peak) and 2 steady-state tests
(5min at 65% VO2peak) within the lab for each trial (2 total). We envision that total time commitment to
lab visits, over the course of the study, to take approximately 12 hours. These visits will be based on you
and the investigators schedules. Finally, care will be taken to make accommodations to fit your
schedule.
What are the benefits of the study?
Individuals who train at levels similar to this study protocols will generally be interested in ways to improve
performance. You will be able to tell after participation in this study how different carbohydrate supplements
affect your performance. You will be provided with your results from the VO2peak test and other performance
tests. This will allow you to compare your aerobic fitness with published information on competitive soccer
players. Also, after completion of this study, your results can be used to guide specific training regimens.
Will I receive payment for participation? Are there costs to participate?
You will not be compensated for your participation in this protocol.
How will my personal information be protected?
The following procedures will be used to protect the confidentiality of your data. The researchers will keep all
study records (including any codes to your data) locked in a secure location. Research records will be labeled
with a code. The code will be derived from a number that reflects how many people have enrolled in the study.
A master key that links names and codes will be maintained in a separate and secure location. The master key
and any other data linking your name to participation in this study will be destroyed after 3 years. All electronic
files (e.g., database, spreadsheet, etc.) containing identifiable information will be password protected. Any
computer hosting such files will also have password protection to prevent access by unauthorized users. Only
the members of the research staff will have access to the passwords. Data that will be shared with others will be
coded as described above to help protect your identity. At the conclusion of this study, the researchers may
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publish their findings. Information will be presented in summary format and you will not be identified in any
publications or presentations.
We will do our best to protect the confidentiality of the information we gather from you but we cannot guarantee
100% confidentiality. Specifically, no guarantees can be made regarding the interception of data sent via the
Internet by any third parties.
You should also know that the UConn Institutional Review Board (IRB) and the Office of Research Compliance
may inspect study records as part of its auditing program, but these reviews will only focus on the researchers
and not on your responses or involvement. The IRB is a group of people who review research studies to protect
the rights and welfare of research participants.
What happens if I am injured or sick because I took part in the study?
In the event you become sick or injured during the course of the research study, immediately notify the principal
investigator or a member of the research team. If you require medical care for such sickness or injury, your care
will be billed to you or to your insurance company in the same manner as your other medical needs are
addressed.
However, if you believe that your illness or injury directly resulted from the research procedures of this study,
you may be eligible to file a claim with the State of Connecticut Office of Claims Commissioner. For a
description of this process, contact the Office of Research Compliance at the University of Connecticut at 860486-8802.
Can I stop being in the study and what are my rights?
You do not have to be in this study if you do not want to. If you agree to be in the study, but later change your
mind, you may drop out at any time. There are no penalties or consequences of any kind if you decide that you
do not want to participate. You will be notified of all significant new findings during the course of the study
that may affect your willingness to continue.
Whom do I contact if I have questions about the study?
Take as long as you like before you make a decision. We will be happy to answer any question you have about
this study. If you have further questions about this study or if you have a research-related problem, you may
contact one of the principal investigators, Carl Maresh (860-486-5322), or the student researcher Brandon Yates
(317-475-8874). If you have any questions concerning your rights as a research participant, you may contact the
University of Connecticut Institutional Review Board (IRB) at 860-486-8802.
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Documentation of Consent:
I have read this form and decided that I will participate in the project described above. Its general purposes, the
particulars of involvement and possible risks and inconveniences have been explained to my satisfaction. I
understand that I can withdraw at any time. My signature also indicates that I have received a copy of this
consent form.
____________________
Participant Signature:
____________________
Print Name:
__________
Date:
____________________
Signature of Person
Obtaining Consent
____________________
Print Name:
__________
Date:
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