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Note: Read this APPLICATION FORMAT completely before you start filling it. Do not
leave any items blank. If any item is not applicable to your study, write “Not Applicable” or
“NA” against that item. We request you to use the soft copy of this format and submit the
printout of a word-processed application (three hard copies and one soft copy on CD).
1. Background Information
Designation :
Academic Qualifications :
Carbohydrates which are the main energy source in most human diets, making up about 40–
80% of our calorie intake play an enormous role in human physiology.Some carbohydrate
foods elicit a quicker response from insulin than others. This is due to differences in the rate
at which they release glucose into the blood. The relative ranking of how fast or slow a
carbohydrate food is converted to glucose after ingestion is a measure of its glycemicindex .
In determining the glycemic index of a carbohydrate food, the postprandial glycemic
response of the food is measured against a reference food. By using the standard method, GI
of selected varieties banana will be determined
3(b) Review of literature (brief, in 3 – 4 paragraphs; include at least 5 key references; provide
complete reference list at the end of this section, with a brief summary of each reference,
highlighting how the study relates to your work)
In the study conducted by,L M Aston et al,(2008) subjects were served with 25 or 50 g
portions of glucose on three occasions, followed by a selection of test foods providing an
equal amount of available carbohydrate, in random order. Each test food was consumed by 10
subjects. Capillary blood glucose levels were measured in the fasted state and over the 120
minutes following commencement consumption of the foods.The GI values of 33 foods were
measured according to the WHO/FAO recommended methodology. These foods included
various breads, breakfast cereals, pasta, rice and potatoes, all of which were commercially
available in the UK.
In the study conducted by Divine Eli Cophie, et al,(2017) the GI of five Ghanaian
staples: fufu (locally pounded), kenkey (Ga), banku, TuoZaafi (TZ), and fufu (Processed
powder) were determined in a crossover trial among 10 healthy nondiabetics. Participants
were given 50 g portions of pure glucose on two different occasions and subsequently the test
foods containing 50 g available carbohydrates. Capillary blood glucose levels of the subjects
at fasting and after ingestion of the glucose and test foods were measured ( using an Ultra 2
glucometer) within a 2‐hour period. The GI of the test foods were calculated by dividing the
incremental area under the glucose response curve (IAUC) of the test food by the IAUC for
the reference food and multiplying the result by 100.
In the study conducted by, Al DhaheriAS,et al, (2017)Glycemic index (GI) and glycemic load
(GL) values of some commonly consumed foods in the United Arab Emirates were
determined with an aim of adding these values to the existing international table of GI and
GL values. In all, eighteen test foods categorised into breads (n 5), entrée dishes (n 3), main
dishes (n 5) and sweet dishes (n 5) were tested. For each test food, at least fifteen healthy
participants consumed 25 or 50 g available carbohydrate portions of a reference food
(glucose). Capillary blood samples were obtained by finger-prick and blood glucose was
measured using clinical chemistry analyser. A fasting blood sample was obtained at baseline
and before consumption of test foods. Additional blood samples were obtained at 15, 30, 45,
60, 90 and 120 min after the consumption of each test food. The GI value of each test food
was calculated as the percentage of the incremental area under the blood glucose curve
(IAUC) for the test food of each participant divided by the average IAUC for the reference
food of the same participant.
REFERENCE
The main objective is to determine the glycemic index value of selected Indian
banana varieties.
5(a) Layout of the study involving human participants / data (Please enclose a flow-chart) :
Enclosed
or
If Yes,
Size of study sample :5
Gender : M F B T
Inclusion Criteria:
BMI 918.5-24.9)
Non diabetic
Healthy(without any complications)
Individuals with basic knowledge on nutrition
Willingness
Exclusion Criteria:
Disease conditions
Age group above 40
If yes,
10. Are you informing the study participants that the biological samples collected will
be used for the stated purpose only?
12. What are the benefits from this study, if any, to the study volunteers?
Not applicable
13. Who will fund your project expenses? (Enclose relevant documents)
Not applicable
I hereby declare that I have completed all sections of this application and attached all the
required documents as described in the ‘Checklist of Documents to be attached with
Application for Review by IHEC’. Ifurther declare that all information provided in this
application and its attachments are true to the best of my/our knowledge and belief. I/We
understand that the approval to this study will be cancelled if Ihave provided any wrong
information or withheld relevant information from this application. Iassure that my/our
project entitled (write the title of your project) Determination of glycemic index of the
locally available banana varieties, if approved by the Institutional Human Ethics
Committee of Avinashilingam Institute for Home Science and Higher Education for Women,
Coimbatore, will be carried out by adhering to the plan described in this application, and that
any deviation from the same will be communicated to the IHEC in writing. I understand that
deviation from the study plan described in this application without informing the IHEC shall
result in the cancellation of approval.
Investigator:
Name: Signature:
Date:
Supervisor:
Name: Signature:
Date:
Name: Signature:
Date:
INFORMED CONSENT FORMAT FOR RESEARCH PROJECTS
(strike off items that are not applicable)
I (write name(s) of the investigator(s) here),M D Srisuruthi am carrying out a study on the
topic Determination of glycemic index of the locally available banana varieties
as part of my research project being carried out under the aegis of the Department ofFood
science and nutrition
Myesearch guide is:Dr.A.Thirumani Devi
(Applicable to students only)
The justification for this study is: As most of the studies on GI of various foods are basically
in other countries except India, GI estimation of Indian foods is required.
The main objective is to determine the glycemic index value of selected Indian
banana varieties.
Secondary Objective(s):
Sample size: 5.
Study volunteers / participants are (specify population group & age group): 20-40 yrs
We request you to kindly cooperate with us in this study. We propose collect background
information and other relevant details related to this study. We will be carrying out:
Data collected will be stored for a period of fifteen years. We will use the data as part of
another study.
Whether blood sample collection is part of routine procedure or for research (study purpose):
Specify purpose, discomfort likely to be felt and side effects, if any: Not applicable.
Will the blood sample collected be stored after study period: Yes
No, it will be destroyed
Will the sample collected be shared with persons from another institution: Yes No
Medication / supplementation given, if any, with duration, side effects, purpose, benefits: Not
applicable.
Benefits from this study, if any :To identify the GI of Indian foods
How will the results be used: The obtained results will be interpreted with the
standardformula,GI of foods will be helpful to identify banan with relatively low glycemic
index.
If you are uncomfortable in answering any of our questions during the course of the interview
/ biological sample collection, you have the right to withdraw from the interview / study at
anytime. You have the freedom to withdraw from the study at any point of time. You will
NOT be paid any remuneration for the time you spend with us for this interview / study. The
information provided by you will be kept in strict confidence. Under no circumstances shall
we reveal the identity of the respondent or their families to anyone. The information that we
collect shall be used for approved research purposes only. You will be informed about any
significant new findings – including adverse events, if any– whether directly or indirectly
related to you or to other participants of this study, developed during the course of this
research which may relate to your willingness to continue participation
Consent: The above information regarding the study, has been read by me/ read to me, and
has been explained to me by the investigator(s). Having understood the same, I hereby give
my consent to them to interview me, and collect biological sample _______ from me. I am
affixing my signature / left thumb impression to indicate my consent and willingness to
participate in this study (i.e., willingly abide by the project requirements)
Duly filled in application for review by the IHEC (all sections must be
1
complete)
Project Timeline/ Gantt Chart showing week-wise activities for the whole
2
study period
Permission letter from the head of the institution from where data is to be
4
collected
9 Confidentiality Statement
* NA = Not Applicable
[Note: Please respond to all the above items in the relevant boxes. Do not leave any item
unmarked]
RESEARCH DESIGN
Collection of data
PHASE-II (fasting blood
Sub-sampling glucose,
(n=5) postprandial
blood glucose
level)
PHASE-
III Analysis
Consolidation Documentation
of data
Project Timeline
Selection of samples
Collection of data
Collection of data
Interpretation of data
Documentation