- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01814735
Substituting Brown Rice For White Rice: Effect On Diabetes Risk Factors In India
March 26, 2015 updated by: Frank B. Hu, Harvard School of Public Health (HSPH)
Currently, India has the largest absolute number of people with diabetes in the world, and evidence indicates that consumption of whole-grains can decrease diabetes by improving glycemic control.
Our study will evaluate the efficacy of substituting brown rice, a whole-grain, for white rice in Chennai, India, on biomarkers of diabetes risk.
The ultimate goal of this research is to provide data for use in designing a global dietary intervention study aimed at reducing diabetes risk through simple, culturally appropriate, feasible and sustainable dietary changes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Currently, India has the largest absolute number of people with diabetes in the world and the escalation in diabetes incidence is occurring as global free trade continues to fuel rapid economic and nutrition transitions, especially in urban settings.
These transitions are accompanied by a shift in dietary consumption towards more highly refined carbohydrates, fats, and animal products.
Evidence indicates that consumption of whole-grains can decrease diabetes by improving glycemic control.
The proposed proof-of-concept trial herein will evaluate the efficacy of substituting brown rice, a whole-grain, for white rice in Chennai, India, on biomarkers of diabetes risk and also will obtain glycemic index values of local rice and other staples.
The long-term goal is to develop a multi-center nutritional-intervention in India, China, Africa and Latin America to create sustainable diabetes prevention strategies through improving carbohydrate quality.
The investigators propose to conduct a 4-month randomized parallel-group intervention trial to evaluate the effects of substitution of brown rice for white rice in two meals per day six days per week on biomarkers for diabetes risk among adults in Chennai, India who are at high risk for the development of diabetes.
The first aim of this research is to determine the glycemic index of different local rice varieties (brown, red, and fully polished white) and preparations (regular or parboiled).
The second aim is to determine the effects of brown rice substitution on fasting biomarker measurements of glucose metabolism (i.e., glucose, insulin, hemoglobin A1c, homeostasis model assessment for insulin resistance), dyslipidemia (i.e., triglycerides, total cholesterol, LDL- cholesterol, and HDL-cholesterol), and inflammation (i.e., C-reactive protein).
This trial will also demonstrate the feasibility and cultural appropriateness of this type of intervention in the local environment to which results may be translated in the future.
This study will have important implications for policy and help local governments develop national nutrition strategies for diabetes prevention such as wide- spread education campaigns about the health benefits of whole-grains, and school lunch programs which serve whole-grains.
Such policies could also encourage ministries of agriculture to support production of whole grains, thereby improving accessibility and regulate costs.
This work is intended to be part of a larger global initiative to identify local, feasible and sustainable dietary interventions to reduce diabetes risk in countries experiencing epidemiologic transition by improving the carbohydrate quality of staple foods.
Initiatives have already been launched by our group in China, and are planned for Tanzania, Nigeria, Puerto Rico and Mexico.
PUBLIC HEALTH RELEVANCE: Currently, India has the largest absolute number of people with diabetes in the world, and evidence indicates that consumption of whole-grains can decrease diabetes by improving glycemic control.
Our study will evaluate the efficacy of substituting brown rice, a whole-grain, for white rice in Chennai, India, on biomarkers of diabetes risk.
The ultimate goal of this research is to provide data for use in designing a global dietary intervention study aimed at reducing diabetes risk through simple, culturally appropriate, feasible and sustainable dietary changes.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chennai, India
- Madras Diabetes Research Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index > 23kg/m2 (India-specific BMI cutpoint for overweight)
- Waist circumference ≥ 90cm if male and ≥ 80cm if female (India-specific cutpoints for abdominal adiposity)
- Daily rice consumption (≥200grams/day, > ~2cups/day) as determined by responses to the screening questionnaire
Exclusion Criteria:
- Self-report of any condition/illness that may affect the study outcomes or would make participation potentially harmful, including diabetes, severe kidney disease, cardiovascular disease (coronary artery disease, peripheral vascular disease), history of stroke, cancer, severe psychological disorders (schizophrenia, dementia), or hypothyroidism, as ascertained by a detailed medical history.
- No plans to relocate in the next year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brown rice
Brown Rice
|
|
Active Comparator: White rice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in fasting blood glucose, lipids, and blood pressure
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and cultural appropriateness
Time Frame: 1 year
|
This trial will also demonstrate the feasibility and cultural appropriateness of this type of intervention in the local environment to which results may be translated in the future.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
March 18, 2013
First Submitted That Met QC Criteria
March 19, 2013
First Posted (Estimate)
March 20, 2013
Study Record Updates
Last Update Posted (Estimate)
March 27, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03TW008726-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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