| CTRI Number |
CTRI/2021/03/032032 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
12/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Biscuits] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glycemic index of high protein high fibre biscuits |
|
Scientific Title of Study
|
"Evaluation of Glycemic Index of high protein high fibre biscuits" |
| 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 and Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research Madras
Diabetes Research Foundation No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
India
Chennai
TAMIL NADU
600086
India |
| Phone |
914439988816 |
| Fax |
|
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific 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 and Dietetics Research Madras
Diabetes Research Foundation No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
India
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 |
Senior Scientist and Head- Department of Foods Nutrition & Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research Madras
Diabetes Research Foundation No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
India
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy’s Laboratories Ltd
7-1-27, Ameerpet
Hyderabad 500016, India
|
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No.6B Conransmith Road,
Gopalapuram
Chennai-600086 |
| Type of Sponsor |
Other [Non-profit research institute] |
|
|
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 |
| Dr V Mohan |
Madras Diabetes Research Foundation |
Department of Foods
Nutrition & Dietetics
Research No 4 Conran
Smith Road
Gopalapuram Chennai
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
914439988816
drmohans@diabetes.ind.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and female overweight individuals (BMI
lesser than or equal to 22.9) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High protein high Fibre Biscuits |
High protein high Fibre Biscuits providing 25/50g available carbohydrate will be given as test food to the study
participants |
| Comparator Agent |
Reference Glucose |
Glucose providing 25/50g available carbohydrate will be given as reference
food on three different occasions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
BMI ≤ 22.9 kg/ m2.
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
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the glycemic index, GI category of high protein high fibre biscuits |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessing the proximates and available
carbohydrates of food products |
7 days |
|
|
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)
|
18/03/2021 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
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 need 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. Capillary blood glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 min using Hemocue Glucose 201+ analyzer (Hemocue®Ltd, Angelholm, Sweden). Standard glucose drink will be given for 3 different days to get average glucose response and each test food for 1 day with a wash out period of 2 to 3 days between each test day. The GI was calculated as IAUC of test food/IAUC of reference (Glucose) food x 100. |