| CTRI Number |
CTRI/2018/05/014043 [Registered on: 22/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Evaluation of Glycemic Index] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Glucose Response of unpolished Foxtail millet, unpolished Little Millet, Multigrain Adai mix and Dr.Mohan’s High Fibre Rice |
|
Scientific Title of Study
|
Glycemic Index testing of Whole Foxtail millet, Whole Little Millet, Multigrain Adai mix and High Fibre Rice lot 36-09022018 |
| 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 |
No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
drmohans@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist & Head Department of Foods Nutrition and Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU
600 086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sudha Vasudevan |
| Designation |
Senior Scientist & Head Department of Foods Nutrition and Dietetics Research |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram
Chennai
TAMIL NADU
600 086
India |
| Phone |
04443968487 |
| Fax |
914428359035 |
| Email |
s2r_7@mdrf.in |
|
|
Source of Monetary or Material Support
|
| Dr.Mohan’s Healthcare Products Pvt Ltd
No 6b Conran Smith Road
Gopalapuram
Chennai
Tamil Nadu
600 086
India |
|
|
Primary Sponsor
|
| Name |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU
600 086
India |
| Type of Sponsor |
Other [Non Government Research Organisation] |
|
|
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 |
No 4 Conran Smith Road
Chennai
TAMIL NADU |
04443968487
914428359035
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 |
Healthy volunteers with normal BMI (18.5 to 22.9 kg/m2) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Reference Glucose |
Participants will have to undergo 3 days of reference food i.e 50g of available carbohydrate containing glucose in 200ml of water. |
| Intervention |
Test food- Whole Foxtail millet, Whole Little Millet, Multigrain Adai mix and Dr.Mohan’s High Fibre Rice |
Test foods (Whole Foxtail millet, Whole Little Millet, Multigrain Adai mix and Dr.Mohan’s High Fibre Rice) containing 50g of available carbohydrates will be fed on different occasion with 2-3days of washout period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals with BMI 18.5-22.9kg/m2 (WHO 2000)
2)Participants aged between 18 and 45 years of both gender
3)Without family history of diabetes
4)Not suffering from any illness or food allergies or on any medication were excluded from the present study.
|
|
| ExclusionCriteria |
| Details |
1)Individuals with BMI lesser than 18.5 kg/ m2 and greater than 23kg/m2 (WHO 2000)
2)Fasting blood glucose value 5•6mmol/l (100 mg/dl)(ADA 2007)
3) On any special diet
4) With family history of diabetes
5) Suffering from any illness or food allergies or on any medication were excluded from the present study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of the glycemic index (GI) of the Whole Foxtail millet, Whole Little Millet, Multigrain Adai mix and Dr.Mohan’s High Fibre Rice |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimation of proximates, available carbohydrates and standardization of recipe |
3 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2017 |
| Date of Study Completion (India) |
20/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Higher consumption of refined grains such as white rice (WR) poses risk for diabetes and CVD (cardiovascular disease). In addition, Indian rice varieties in their polished forms show high glycemic index. Whole grains are rich in micronutrients, phytonutrients, dietary fibre and has shown good promise in reducing glycemic response. This study aims to evaluate Glycemic Index of whole grains (Foxtail millet, Little Millet), a formulation using whole grains (Multigrain Adai mix) and Dr.Mohan’s High fibre rice. Multigrain adai (a south Indian tiffin item prepared as a pancake from
the batter of rice, pulses and spices) mix. The
mix contains 45% legumes and is coarsely ground and may aid in slower digestion
and absorption upon consumption, hence may aid in controlling post meal blood
sugar levels. It is a healthier choice for the whole family. Currently millets are very popular in the market and refined millets are sold which are starchy.
Unpolished millets are healthier alternatives as they contain higher levels of
fibre and micronutrients.
The study results indicated that both the unpolished millets were of high GI and the adai mix was of medium GI category. |