| CTRI Number |
CTRI/2025/03/081725 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cereal and coconut milk based residue based puttu and chappathi] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluation of glycemic index puttu and chappathi made from cereal and coconut milk residue |
|
Scientific Title of Study
|
Evaluation of glycemic index of cereal and coconut milk residue based puttu and chappathi |
| Trial Acronym |
NIL |
|
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 |
Director, Madras Diabetes Research Foundation |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition Dietetics Research,
NO.6B, CONRAN SMITH ROAD, GOPALAPURAM
Chennai
TAMIL NADU
600086
India |
| Phone |
044439688888 |
| Fax |
914428359035 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Director, Madras Diabetes Research Foundation |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research
Madras Diabetes Research Foundation
NO.6B, CONRAN SMITH ROAD, GOPALAPURAM
Chennai
TAMIL NADU
600086
India |
| Phone |
044439688888 |
| Fax |
914428359035 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist and Head- Department of Foods, Nutrition & Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition & Dietetics Research,
NO.6B, CONRAN SMITH ROAD, GOPALAPURAM
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| ICAR-Central Plantation Crops Research Institute
Kudlu P.O., Kasaragod
Kerala - 671124 |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
NO 4, CONRAN SMITH ROAD, GOAPALAPURAM, 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 |
| Mrs Sudha Vasudevan |
Madras Diabetes Research Foundation |
Department of Foods Nutrition and Dietetics Research
NO 6B, CONRAN SMITH ROAD, GOPALAPURAM
Chennai
TAMIL NADU |
9840014480
914428359035
s2r_7@mdrf.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MadrasDiabetesResearchFoundationInstitutionalEthicsCommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy participants with normal body mass index |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CEREAL AND COCONUT MILK RESIDUE BASED PUTTU AND CHAPPATHI |
50/25g available carbohydrate providing puttu and chappathi made from cereal and coconut milk residue with 250/125ml water will be given as test food once during the study period on separate occasions. Capillary blood samples will be collected at baseline -5,0 mins and subsequently at 15,30,45,60,90,120 mins post consumption of test and reference foods. |
| Comparator Agent |
Reference food |
The reference food 50/25g available carbohydrate serving glucose with 250/125ml water will be given thrice on separate occasions in-between the test foods in random order. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 45 years
BMI greater than equal to 18.5 to less than
equal to 22.9 kg/ m2 (as per WHO cut offfor 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, acetylsalicylicacid, thyroxin, vitamins and mineralsupplements 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 majoreffectson glucose metabolism and body fat distribution). |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic index and GI category of food products |
The foods will be tested on one single occasion to determine the GI. |
|
|
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)
|
17/03/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: 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 people with diabetes 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 cereal and coconut milk residue based puttu and chappathi. |