| CTRI Number |
CTRI/2023/04/051530 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional beverage] |
| Study Design |
Other |
|
Public Title of Study
|
Glycemic Index of Diabetes Specific Nutrition Formulation (NUC-RDM) |
|
Scientific Title of Study
|
Determination of Glycemic Index of Diabetes Specific Nutrition Formulation (NUC-RDM)
|
| 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 |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Diabetology
No.6B Conron Smith Road, Gopalapuram
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 |
Director |
| Affiliation |
MADRAS DIABETES RESEARCH FOUNDATION |
| Address |
Department of Diabetology
No.6B Conron Smith Road, Gopalapuram
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 and Head of 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, Conron Smith Road,
Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
914439988816 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Nucgnex Life sciences, India
101,First Floor, Ecstasy -C Wing Near City Pride, above Utsav Saree Shop, Kothrud, Pune, Maharashtra 411038 |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research, Madras Diabetes Research Foundation, No.4 Conran Smith 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 |
| Mrs Sudha Vasudevan |
Madras Diabetes Research Foundation |
Department of Foods, Nutrition and Dietetics Research,
NO.4, Conron Smith Road,
Gopalapuram
Chennai
TAMIL NADU |
044439688888
s2r_7@mdrf.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 |
Healthy participants with normal BMI |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NUC-RDM with water |
25/ 50 g available carbohydrate providing NUC-RDM with water will be given to study participants as test food
once on a separate day and capillary blood samples will be
collected for the subsequent 2 hours. |
| Comparator Agent |
Reference glucose |
25/50g available carbohydrate providing glucose in
125ml/250ml water is given as reference food three times during the study period on separate occasions in-between the test foods. Capillary blood samples will be collected for the subsequent 2 hours |
|
|
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 (asper 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 oralcontraceptives) — stable doses of oral contraceptives, acetylsalicylicacid, thyroxin, vitamins and mineral supplements or drugs to treathypertension or osteoporosis are acceptable. |
|
| ExclusionCriteria |
| Details |
a known history of diabetes mellitus or the use of anti-hyperglycemicdrugs or insulin to treat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within thepreceding 3 months;
the presence of disease or drug(s) which influence digestion andabsorption 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 |
| Glycemic index, Glycemic Response and GI category of food products |
For both intervention and comparator agents capillary blood samples will be collected at -5,0 (fasting state) and at 15,30,45,60,90,120 mins from the first sip of test and reference foods. Testing of all foods will be done 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)
|
25/04/2023 |
| 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 hyper insulinemia, 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 diabetes specific nutrition formulation (NUC-RDM) |