| CTRI Number |
CTRI/2022/03/041107 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
14/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition Supplement] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glycemic Index testing of high protein supplement |
|
Scientific Title of Study
|
Evaluation of Glycemic Index and Glycemic Response of high protein nutrition supplement with immuno nutrients for people with muscle and weight loss |
| 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 |
President & Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.4 Conransmith Road, Gopalapuram
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
914439988816 |
| Fax |
914428359035 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
President & Chief of Diabetes Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No.4 Conransmith Road, Gopalapuram
Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
914439988816 |
| Fax |
914428359035 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist & Head- Department of Foods Nutrition & Dietetics Research |
| 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
No 6B Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
914439988816 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition & Dietetics Research
Madras Diabetes Research Foundation,
No.4 Conransmith Road, Gopalapuram
Chennai-600086
|
| 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 |
| SUDHA VASUDEVAN |
Madras Diabetes Research Foundation |
Department of Foods
Nutrition & Dietetics
Research
No 4
Conran Smith Road
Gopalapuram
Chennai
Chennai
TAMIL NADU |
9840014480
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 |
BMI greater than 18.5 and less than 22.9 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference-Glucose |
Glucose providing 25/50g available carbohydrate will
be given as reference food thrice during the study
period
|
| Intervention |
Test Food |
25/50g available carbohydrate providing test food high protein nutrition supplement with immuno nutrients with milk |
| Intervention |
Test Food |
25/50g available carbohydrate providing test food high protein nutrition supplement with immuno nutrients with water |
|
|
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
|
|
| ExclusionCriteria |
| Details |
a known history of diabetes mellitus or the use of antihyperglycemic 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic index (GI) category of food products |
Capillary blood glucose will be assessed at -5, 0 (fasting), 15, 30, 45,60,90,120 mins post ingestion of test and reference foods. The testing will be done on separate days for test and reference foods. |
|
|
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 high protein nutrition supplement with immuno nutrients for people with muscle and weight loss |