NCT01814735

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

March 18, 2013

Last Update Submit

March 26, 2015

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Changes in fasting blood glucose, lipids, and blood pressure

    4 months

Secondary Outcomes (1)

  • Feasibility and cultural appropriateness

    1 year

Study Arms (2)

Brown rice

EXPERIMENTAL

Brown Rice

Other: Brown riceOther: White rice

White rice

ACTIVE COMPARATOR

White rice

Other: Brown riceOther: White rice

Interventions

Brown riceOTHER
Brown riceWhite rice
White riceOTHER
Brown riceWhite rice

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madras Diabetes Research Foundation

Chennai, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Epidemiology

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

August 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

IN(1)