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AVINASHILINGAM INSTITUTE FOR HOME SCIENCE

AND HIGHER EDUCATION FOR WOMEN


COIMBATORE – 641043, India

Application for Review of Project Proposal by the


Institutional Human Ethics Committee
For student research projects and non-student, non-clinical trial projects

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

1. Title of your proposed research project (fill in the box below):

Determination of glycemic index of the locally available banana varieties

2. Brief profile of those involved in the project:

2(a) To be filled in for Student Projects :

Name of the Student (Principal Investigator) : M D Srisuruthi

Course of Study and year :IM.Sc Food Science and Nutrition


(2017-2019)

Name of the Supervisor :Dr.A.Thirumani Devi

Contact Number (mobile) :+(91) 8870620888

For office use only IHEC Application No.

Date of Receipt of application in the IHEC: IHEC SEAL:

Date forwarded to IHEC (Primary Reviewer):


Date forwarded by IHEC to Reviewers:
Date of IHEC Panel Review, if applicable:
Date of despatch of approval letter by IHEC:
2(b) To be filled in for non-Student Projects (within our University): Not Applicable

Name of the Principal Investigator :

Designation :

Department where the study is to be executed :

Is the project funded by external agency? :  Yes  No

If yes, Name of the agency :

Contact Number (mobile) :

2(c) To be filled in for non-Student Projects (external members):Not Applicable

Name of the Principal Investigator :

Academic Qualifications :

Designation and Department :

Institution where the study is to be executed :

Reason(s) for submission to our University for ethical clearance:

Is the project funded by external agency? :  Yes No

If yes, Name of the agency :

Contact Number (mobile) :


3. Particulars about the proposed project

4. Background of the project:

3(a) Introduction (brief, in 4 – 5 lines)

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.

The study conducted by Juma M Alkaabi(2011),was designed to determine the glycemic


indices of five commonly used varieties of dates in healthy subjects and their effects on
postprandial glucose excursions in individuals with type 2 diabetes mellitus.Composition
analysis was carried out for five types of dates (Tamer stage). The weights of the flesh of the
dates equivalent to 50 g of available carbohydrates were calculated. The study subjects were
thirteen healthy volunteers, and ten participants with type 2 diabetes. Each subject was tested
on eight separate days with 50 g of glucose (on 3 occasions) and 50 g equivalent of available
carbohydrates from the 5 varieties of date (each on one occasion). Capillary glucose was
measured in the healthy subjects at 0, 15, 30, 45, 60, 90 and 120 min and for the diabetics at
0, 30, 60, 90, 120, 150 and 180 min. The glycemic indices were determined as ratios of the
incremental areas under the response curves for the dates compared to glucose.

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

1) L M Aston, J M Gambell, D M Lee, S P Bryant & S A Jebb on Determination of


the glycaemic index of various staple carbohydrate-rich foods in the UK diet , in
Europe journal of clinical nutrion
feb,2008 vol 62(2) page 279-285
2) Al Dhaheri AS, Henry CJK, Mohamad MN, Ohuma EO, Ismail LC, Al Meqbaali
FT, Jarrar AH, on, Glycaemic index and glycaemic load values of commonly
consumed foods in the United Arab Emirates. In The britishjournal of nutrition,
volume 117, issue 8, 28 april,2017 page no 1110-1117.
3) Divine EC, Jacob K. Agbenorhevi, and Reginald A. on Glycemic index of some local
staples in Ghana Food science and nutrition
2017 jan,vol5(1) page 131-138

4) Juma m alkaabi,mdFaculty of Medicine and Health Sciences, UAE University on


Glycemic indices of five varieties of dates in healthy and diabetic subjects in
Nutrition journal

2011 march, vol 10(59) doi:10.1186/1475-2891-10-59.


Objectives of the study:

4(a) Primary Objectives:

 The main objective is to determine the glycemic index value of selected Indian
banana varieties.

4(b) Secondary Objectives:

 To identify the banana with low glycemic value.

 To analyse weather the banana consumption is suitable for the consumption of


diabetic individuals.

5. Methodology of the study:

5(a) Layout of the study involving human participants / data (Please enclose a flow-chart) :
Enclosed

5(b) Type of data to be generated in the study:

Are you going to

Collect data afresh from the study-volunteers?  Yes  No

or

Collect pre-existing data from case-sheets/other sources?  Yes  No

5(c) Data Collection Tool to be used : (Forms / Questionnaire etc) Not


applicable

Specimen Copy to be enclosed.

5(d) Area / Location of the study : coimbatore

5(e) Type of study population : Non diabetic, healthy

5(f) Does the study involve sampling : Yes No

If Yes,
Size of study sample :5

Estimation of study size :Not applicable

Age group of study sample : 20-40 yrs

Gender :  M  F  B  T

[M-male; F-female; B-both male and female; T-transgender]

Sampling Method : Random sampling

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

6. Duration of the study : 1 month

7. Proposed date of commencement of the study : January,2018

8. Evaluation Plan proposed:


[Outlinehow the aims of the study will be measured / what will be considered as success
or otherwise, of the study]

The GI of the selected varieties of banana is will be estimated.

9. Dissemination of the findings of the study: [Tick as many as applicable]

Scientific meets (Conferences / Seminars etc.)


 Departmental review meets
 Doctoral Committee
Publications
 Thesis
 Project report to funding agency
 Other (Please specify)
Does the study involve collection of biological material?  Yes  No

If yes,

Type of sample to be collected (blood, urine, etc.) : Blood

Quantity of sample to be collected :<1ml

Size of the collection : From all study volunteers

From a sub-sample of size 5

Parameter(s) to be estimated in the biological sample:

o Fasting blood glucose levels


o Postprandial blood glucose levels

10. Are you informing the study participants that the biological samples collected will
be used for the stated purpose only?

 Yes  No  Not applicable

11. Do you anticipate any risk to the study volunteers?  Yes  No

If yes, what type of risk is anticipated?

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

14. Conflict of Interest, if any : Not applicable


DECLARATION

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.

Name(s) and Signature(s) of the Investigator(s)&Supervisor(s) involved in this project:

Investigator:

Name: Signature:

Date:

Supervisor:

Name: Signature:

Date:

Head of the Department:

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 objectives of this study are:


Primary Objective(s):

 The main objective is to determine the glycemic index value of selected Indian
banana varieties.

Secondary Objective(s):

 To identify the banana with low glycemic value.

 To analyse weather the banana consumption is suitable for the consumption of


diabetic individuals.

Sample size: 5.

Study volunteers / participants are (specify population group & age group): 20-40 yrs

Location of the study: Coimbatore,Tamilnadu,India.

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:

Initial interview (specify approximate duration):______ minutes. Not applicable.

Data collected will be stored for a period of fifteen years. We will use the data as part of
another study.

Health education sessions: Number of sessions: _____________. Not applicable.

Approximate duration of each session: ______________ minutes. Not applicable.


Clinical examination (Specify details and purpose):

Blood sample collection: Specify quantity of blood being drawn: <1ml.


No. of times it will be collected: 5

Whether blood sample collection is part of routine procedure or for research (study purpose):

Routine Procedure Research 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 blood sample collected be sold: Yes No

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.

Is the medication / supplementation given part of routine procedure: Yes No


(If no, state reasons for giving this medication/supplementation)

Are alternatives available for medication / supplementation given: Yes No


(If no, state reasons for giving this particular medication/supplementation)

Final interview (specify approximate duration):_________ minutes. Not applicable.

If photograph is taken, purpose: Report submission

Benefits from this study, if any :To identify the GI of Indian foods

Risks involved by participating in this study, if any :Not applicable.

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)

Signature / Left thumb impression of the Study Volunteer / Legal Representative:

Signature of the Interviewer with date

Signature of the Witness with name:

Checklist of Documents to be attached with Application for Review by IHEC


Sl.
Document Yes No NA*
No.

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

Copy of Letter granting funds / Studentship / Scholarship / Fellowship (if 


3
applicable)

Permission letter from the head of the institution from where data is to be 
4
collected

5 Informed Consent Form in English 

6 Informed Consent Form translated into the relevant language(s) 

7 Patient Information Sheet in English, if applicable 

Patient Information Sheet translated into the relevant language(s), if 


8
applicable

9 Confidentiality Statement 

Data collection tool (Questionnaire / form, etc.) in English [Please enclose 


10
sample copy]

Data collection tool (Questionnaire / form, etc.) translated into the 


11
relevant language(s) [Please enclose sample copy]

12 Current CV of the Principal Investigator and / or Supervisor 

13 All relevant pre-clinical animal data 

14 Compensation for study participation 

15 Any other information relevant to the study (Provide list) 

* NA = Not Applicable

[Note: Please respond to all the above items in the relevant boxes. Do not leave any item
unmarked]
RESEARCH DESIGN

PHASE-I Selection of Selection of


five varities of Sampling
area
bananas for (n=10)
the study (coimbatore)

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

Week 1 Week 2 Week 3 Week 4

Selection of samples

Collection of data

Collection of data

Interpretation of data

Documentation