CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 03:07:46 GMT)

CTRI Number CTRI/2018/05/014010 [Registered on: 21/05/2018] - Trial Registered Retrospectively Last Modified On 15/05/2018 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 Brown Rice flakes, White Rice flakes and ADT 45 Parboiled Brown rice Scientific Title of Glycemic Index Testing of Brown Rice Flakes Upma, White Rice Flakes Upma and ADT 45 Study Parboiled Brown Rice Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr V Mohan Trial Coordinator (multi-center study) Designation President and Chief of Diabetes Research Affiliation Madras Diabetes Research Foundation Address No 4 Conran Smith Road Gopalapuram Chennai TAMIL NADU 600 086 India Phone 04443968888 Fax 914428359035 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Mrs Sudha Vasudevan Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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

TAMIL NADU 600 086 India Phone 04443968487 Fax 914428359035

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Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dr.Mohan’s Healthcare Products Pvt Ltd No 6b Conran Smith Road Gopalapuram Chennai TAMIL NADU 600 086 India Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr V Mohan Madras Diabetes No 4 Conran Smith 04443968888 Research Foundation Road Gopalapuram 914428359035 Chennai TAMIL NADU [email protected] Chennai d.in TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Madras Diabetes Approved 17/04/2012 No Research Foundation Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Healthy volunteers with normal BMI (18.5 to 22.9 kg/m2) Intervention / Type Name Details Comparator Agent 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- White Rice flakes, Test food containing 50g of Brown Rice flakes and ADT 45 available carbohydrates will be Parboiled Brown rice fed on different occasion with 2-3days of washout period. Inclusion Criteria 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.

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Exclusion Criteria Exclusion Criteria 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 Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Determination of the glycemic index (GI) of the 5 months brown rice flakes, white rice flakes and ADT 45 parboiled brown rice. Secondary Outcome Outcome Timepoints Estimation of proximate and available 2 months carbohydrates Target Sample Size Total Sample Size=15 Sample Size from India=15 Final Enrollment numbers achieved (Total)=15 Final Enrollment numbers achieved (India)=15 Phase of Trial N/A Date of First 24/10/2015 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details none yet Brief Summary The prevalence of diabetes in India is rising rapidly. Asian Indians (South

Asian) have higher propensity to diabetes. Consumption of refined cereal grains such as white rice and refined wheat flour may be one of the drivers

of the diabetes epidemic in India. Whole grain foods and foods with lower glycemic properties are recommended for those at risk or with diabetes,

and related metabolic disorders.

Flattened rice (rice flakes), one of the commonly consumed food products in India, is poor in fibre and hence likely to have higher glycemic

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index (GI). We attempted to prepare brown rice flakes (BRF) using a novel technology. We evaluated the glycemic properties of Whole grain (ADT-45 Parboiled Brown Rice) and rice flakes (Brown and white rice). Brown rice flakes (in the form of upma), and ADT-45 Parboiled Brown rice showed lower glycemic index compared to commercial white rice flakes. We conclude that Brown rice and brown rice flakes are healthier alternative choices to commercial white rice flakes.

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