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1. Study Information
Protocol Title:
Investigating the relationship between intelligence, personality traits and physiological
characteristics in healthy adults.
Principal Investigator & Contact Details:
Dr. Bobby Cheon
Clinical Nutrition Research Centre, Singapore Institute of Clinical Research
Brenner Centre for Molecular Medicine, 30 Medical Drive, Singapore 117609
Tel: +65 64074060 Email: Bobby_Cheon@sics.A-star.edu.sg
2. Purpose of the Research Study
You are invited to participate in a research study. It is important to us that you first take time
to read through and understand the information provided in this sheet. Nevertheless, before
you take part in this research study, the study will be explained to you and you will be given
the chance to ask questions. After you are properly satisfied that you understand this study,
and that you wish to take part in the study, you must sign this informed consent form. You
will be given a copy of this consent form to take home with you.
You are invited because you are a healthy adult between the ages of 21 to 30 years. You are
a non-smoker, a healthy male adult, have no adverse metabolic conditions (i.e. diabetes,
cardiovascular disease, chronic hypertension), thyroid disorders, not allergic or intolerant to
food (i.e. lactose intolerance).
This study is carried out to examine the relationship between intelligence, personality traits
and physiological characteristics in healthy adults.
This study will recruit participants from the National University of Singapores campus (or
wider) community over the period; Oct 2015 to July 2016. About 70 participants will be
involved in this study.
3. What procedures will be followed in this study
If you take part in this study, the following will be asked of you:
Your involvement in the study will be for about two weeks. You will be asked to participate in
three separate sessions; which will involve one online survey session (available remotely)
and two onsite experimental test sessions (i.e. only two visits to the lab). The onsite
sessions will be conducted at the Clinical Nutrition Research Centre (CNRC) which is located
on the 7th floor of 14 Medical Drive, MD-6 Building.
Session 1
Online Survey
(Approx. 20 min)
Session 2
Onsite Test Session
(Approx. 120 min)
Session 3
Onsite Test Session
(Approx. 120 min)
Session 1
Your initial involvement will require you to undergo an online survey to gauge your suitability
for the study. The online survey can be accessed from a computer/mobile device with a
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compatible web-browser (i.e. Internet Explorer, Chrome, Safari) and Internet connection at
your convenience. The screening survey will include a health questionnaire to determine:
If you have any medical or metabolic conditions
If you are on any prescribed medication
If you have any known allergies or intolerance to food
Your usual physical activity levels and eating behaviour
For inclusion in this study, you will have to fulfil the following requirements:
Male
Literate in English
Age between 21 to 30 years
Normal fasting blood glucose levels 5.9 mmol/L
Non-smoker
Do not have any major medical conditions including diabetes, hypertension, thyroid
dysfunction, metabolic and/or cardiovascular diseases
No know allergies or intolerance to food (e.g. lactose intolerance)
Not on any prescribed medication
No aversion to blood sampling procedures (e.g. finger prick, cannulation)
Session 2 and 3
The following two sessions will involve visiting the laboratory at CNRC for testing. This will be
performed on the same day of the week, a week apart. You will be required to record all food
and drink consumption on the day prior to each visit. In addition, you will be asked to refrain
from alcohol consumption and vigorous activity in the 24 h period before each visit. For each
laboratory visit, you will be required to fast overnight for 10 hours before reporting at CNRC
in the morning at about 9.00am. You will be asked to consume a standardized amount of
plain water (250 ml) in the morning before coming into the laboratory. It is also recommended
to wear comfortable clothing with sleeves ending above the elbow for the visits.
At the start of your first visit (session 2), you will be given ample time to read this Informed
Consent Form again and the opportunity to ask questions. Once you are fully informed of this
study and have all your questions satisfactorily answered, you will complete and sign this
consent form in the presence of the researcher. This form will be also made available for
reference during the online survey session. Following this, both sessions will be identical in
all respects/procedures. You will be required to:
Undergo anthropometric measurements that include height, weight and body
composition. Body composition measurements will include body fat mass and percentage
using bioelectrical impedance analyser.
Undergo blood (1st of 3) and saliva (1st of 2) collection
- Blood collection will involve both finger prick and catheter-based protocols. These
procedures will be performed by an experienced phlebotomy trained research nurse.
In total, about 5 ml, which is about one teaspoon of blood will be collected at each
blood collection time-point. Any blood or tissue specimens obtained during the course
of this study will be securely stored and analysed for the purposes of this research
project and will be destroyed after completion of the project#. Biological samples will
be analysed for a range of metabolic and physiological variables (i.e. blood glucose
concentration).
#
However, if given permission to retain and not discard the biological samples
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collected in this study, we may analyse it for future research. There will be an option
to state your decision in the informed consent form.
- Saliva collection will involve the use of dental (cotton) rolls, which are dental rolls that
are routinely used during dental procedures to absorb/collect saliva. Again, this
collection will be performed by trained personnel. Saliva samples will be analysed
during the session and will not be stored.
Following the initial measurements, you will be required to complete a quiz that consists
of puzzles and problem-solving questions, and questionnaires about yourself that will
take approximately 30 min.
Following the completion of the quizzes and questionnaires and a round of blood (2nd of
3) and saliva (2nd of 2) collection, you will be required to finish (consume in its entirety) a
test meal (chilled chocolate milkshake), which will be provided by the researcher.
Approximately 30 min after the consumption of the test meal, during which you will be
required to relax and rest while watching a video, a final set of blood (3rd of 3) collection
and questionnaires will be completed here.
After leaving the laboratory, you will be required to maintain a food journal for the
remainder of the day.
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and fat mass), blood glucose measures (fasting and post meal), blood pressure. These costs
will be borne by Singapore Institute of Clinical Sciences (SICS).
You will be reimbursed for your time, inconvenience and transportation costs as follows:
If you complete one onsite visit, you will be paid $35.00.
If you complete the study (two onsite visits), you will be paid $75.00.
9. Voluntary Participation
Your participation in this study is voluntary. You may stop participating in this study at any
time. Your decision not to take part in this study or to stop your participation will not affect
your medical care or any benefits to which you are entitled. If you decide to stop taking part
in this study, you should tell the Principal Investigator.
However, the data that have been collected until the time of your withdrawal will be kept and
analysed. The reason is to enable a complete and comprehensive evaluation of the study.
The biological samples collected for the study will be deemed to be gifted to SICS and will
not be returned to you. However, you retain your right to ask the Principal Investigator to
discard or destroy any remaining samples if they have not been de-identified. If given
permission to retain and not discard the biological samples collected in this study, these
samples may be made available to other researchers and analysed for future research. All
biological samples will be de-identified. There will be an option to state your decision in the
informed consent form.
In addition, you may be re-contacted to participate in future follow-up studies if you agree. If
you agree, you will need to indicate your preferred mode of contact e.g. email, phone
number.
Your doctor, the Investigator of this study and/or SICS may stop your participation in the
study at any time if they decide that it is in your best interests. They may also do this if you
do not follow instructions required to complete the study adequately. If you have other
medical problems or side effects, the doctor and/or nurse will decide if you may continue in
the research study.
10. Compensation for Injury
If you follow the directions of the doctors in charge of this study and you are physically
injured due to the trial substance or procedure given under the plan for this study, SICS will
pay the medical expenses for the treatment of that injury. Payment for management of the
normally expected consequences of your treatment will not be provided by SICS.
SICS without legal commitment will compensate you for the injuries arising from your
participation in the study without you having to prove SICS is at fault. There are however
conditions and limitations to the extent of compensation provided. You may wish to discuss
this with your Principal Investigator. By signing this consent form, you will not waive any of
your legal rights or release the parties involved in this study from liability for negligence.
11. Confidentiality of Study Data and Records
Information collected for this study will be kept confidential. Your records, to the extent of the
applicable laws and regulations, will not be made publicly available. By signing the Informed
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Consent Form attached, you (or your legally acceptable representative, if relevant) are
authorizing (i) collection, access to, use and storage of your Personal Data, and (ii)
disclosure to authorized service providers and relevant third parties.
Data collected and entered into the Data Collection Forms are the property of SICS. In the
event of any publication regarding this study, your identity will remain confidential.
If you agree, your coded data (i.e. with no personal identifiers) in this study may be made
available to other qualified scientists for future research.
The study has been reviewed by the NUS Institutional Review Board for ethics approval.
For an independent opinion regarding the research and the rights of research participants,
you may contact a staff member of the National University of Singapore Institutional Review
Board (Attn: Mr Chan Tuck Wai, at telephone 65- 6516 1234 or email at irb@nus.edu.sg
If you have any complaints or feedback about this research study, you may contact the
Principal Investigator or the NUS Institutional Review Board.
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CONSENT FORM
Protocol Title:
Investigating the relationship between intelligence, personality traits and physiological
characteristics in healthy adults.
Principal Investigator & Contact Details:
Dr. Bobby Cheon
Clinical Nutrition Research Centre, Singapore Institute of Clinical Research
Brenner Centre for Molecular Medicine, 30 Medical Drive, Singapore 117609
Tel: +65 64074060
Email: Bobby_Cheon@sics.A-star.edu.sg
I voluntarily consent to take part in this research study. I have fully discussed and
understood the purpose and procedures of this study. This study has been explained to me
in a language that I understand. I have been given enough time to ask any questions that I
have about the study, and all my questions have been answered to my satisfaction.
(de-identified) blood samples and be made
available to other qualified researchers for any future research OR
store my (de-identified) blood samples and be made
available to other qualified researchers for future related research limited to metabolic
disease (i.e. diabetes, obesity, cardiovascular disease) OR
blood samples for future related research.
for my coded data be made available to other qualified researchers for future
research.
-contacted to participate in future follow-up studies in CNRC.
_______________________
Name of Participant
_____________________________
Signature
_________________
Date
Investigator Statement
I, the undersigned, certify that I explained the study to the participant and to the best of my
knowledge the participant signing this informed consent form clearly understands the nature,
risks and benefits of his / her participation in the study.
_______________________ _____________________________
Name of Investigator /
Signature
Person administering consent
_________________
Date
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