| CTRI Number |
CTRI/2022/03/040940 [Registered on: 09/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [foods] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glycemic Index of food preparations with and without Fenuflakes |
|
Scientific Title of Study
|
Evaluation of Glycemic Index of food preparations with and without Fenuflakes (n=12 foods) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
President & Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research
No.4 Conran smith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
|
| Fax |
|
| Email |
drmohan@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Sr. Scientist and Head |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods, Nutrition & Dietetics Research, Madras
Diabetes Research Foundation, No 4, Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
No.4 Conransmith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Sr Scientist and Head |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods, Nutrition & Dietetics Research, Madras
Diabetes Research Foundation, No 4, Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
No.4 Conransmith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Indus Biotech Pvt. Ltd. |
| Madras Diabetes Research Foundation |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition & Dietetics Research
Madras Diabetes Research Foundation
No 4, Conran Smith Road, Gopalapuram,
Chennai 600086, India
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MrsSudha Vasudevan |
Madras Diabetes Research Foundation |
Department of Foods
Nutrition & Dietetics
Research No 4 Conran
Smith Road
Gopalapuram Chennai
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9840014480
914439988816
s2r_7@mdrf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female overweight individuals (BMI
less than or equal to 22.9) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control foods |
plain cooked white rice, dosa, aloo paratha, white bread + potato sandwich, instant oats porridge, sooji upma without ‘‘fenuflakes’ providing 25/50 g available carbohydrate will be given per volunteer as control food on 6 different days. |
| Comparator Agent |
Reference Glucose |
Glucose providing 25/50g available carbohydrate will be given as reference
food thrice during the study
period |
| Intervention |
Test food with fenuflakes |
plain cooked white rice, dosa, aloo paratha, white bread + potato sandwich, instant oats porridge, sooji upma with (test) ‘‘fenuflakes’ providing 25/50 g available carbohydrate will be given per volunteer as test food on 6 different occassion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age -18 to 45 years
BMI ≥18.5 to ≤ 22.9 kg/ m2 (as per WHO cut off for normal BMI)
Both male and female
Willingness to consume the test foods
no known food allergy or intolerance;
no medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable.
|
|
| ExclusionCriteria |
| Details |
a known history of diabetes mellitus or the use of anti-hyperglycemic drugs or insulin to treat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within the preceding 3 months;
the presence of disease or drug(s) which influence digestion and absorption of nutrients;
the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the glycemic index, GI category of food products |
assessed at 6 different time points-15,30,45,60,90,120 mins post ingestion of each of the test foods. Each foods will be tested on separate days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research studies have shown that
lifestyle; in particular dietary aspects play an important role in preventing /
increasing the burden of the chronic diseases. Dietary habits could therefore
be modified to exert a positive impact in the prevention and treatment. It has
been suggested that the high glycemic carbohydrate foods -those foods
containing carbohydrates which elicit rapid blood glucose rise and thereby
increase the insulin demand leading to hyperinsulinemia, insulin resistance and
type 2 diabetes. Hence, there is a need to understand the blood glucose raising
potential of foods in India to be of an important tool to aid in the prevention
and or management of diabetes and its complication. Thus, evolved the concept
of ‘Glycemic Index’ (GI) which ranks the foods, based on the speed at which the
food raises the blood glucose in a scale of 0 to 100, 100 indicating high
glycemic index corresponds to oral glucose’s GI. Today, India leading the world
with the largest number of diabetic volunteers causing a heavy economic burden
to the country urgently needs to look at cost effective strategies to combat
this situation. A cost-effective dietary approach like estimating and
understanding the role of glycemic index of various Indian foods in the
lifestyle related diseases like diabetes is urgently needed.
Aim: To measure glycemic index
(GI) of food
preparations with and without
‘fenuflakes’ (n=12) |