| CTRI Number |
CTRI/2025/02/080882 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cooked plain rice, fermented rice, and rice stored in refrigerator] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glycemic index testing of rice control, fermented, and refrigerated forms |
|
Scientific Title of Study
|
Glycemic index of control, fermented and refrigerated rice |
| 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 |
Chairman, Madras Diabetes Research Foundation |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition & Dietetics Research
Madras Diabetes Research Foundation
No.6B, Conran Smith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840014480 |
| Fax |
914428359035 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Chairman, 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 |
9840014480 |
| 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 and Dietetics Research
Madras Diabetes Research Foundation
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
|
| Madras Diabetes Research Foundation
No. 6B Conransmith Road Gopalapuram Chennai 600086 |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
Department of Foods Nutrition and Dietetics Research,
Madras Diabetes Research Foundation
No 6B, 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 |
| Dr V Mohan |
Madras Diabetes ResearchFoundation |
Department of Foods Nutrition Dietetics Research No 4, Conran Smith Road, Gopalapuram
Chennai
TAMIL NADU |
9840014480
914428359035
drmohans@diabetes.ind.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras Diabetes Research FoundationInstitutionalEthicsCommittee |
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 |
Cooked plain rice, fermented rice, and rice stored in refrigerator (1st, 2nd, and 3rd days of storage) |
50/25g available carbohydrate providing cooked plain rice (control), fermented rice, and rice stored in refrigerator (1st, 2nd, and 3rd days of storage)250/125ml water will be given as test food once during the study period on separate occasions. |
| Comparator Agent |
Reference food |
50/25g available carbohydrate providing glucose in 250/125ml water is given as reference food three times during the study period on separate occasions in-between the test foods. |
|
|
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 totreat diabetes and related conditions
pregnant or lactating women
a major medical or surgical event requiring hospitalization within the preceding 3months
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
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic index and GI category of food products. |
Glycemic index testing of reference and testfoods will be done
on separate days. 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 oftest
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)
|
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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 are 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 cooked plain rice, fermented rice, and rice stored in refrigerator (1st,
2nd, and 3rd days of storage). |