Brown Rice Intervention on Metabolic Syndrome (BRIMS) (BRIMS)

A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk

The specific aim of this study is to determine the effects of substituting brown for white rice on the treatment of metabolic syndrome (MetS).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Dietary supplement: Brown rice/White rice

Detailed Description

Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and CVD. It has become one of the major public health challenges in China due to rapidly nutrition transition and the nature of obesity epidemic. Treatment of MetS in China is very important for the prevention of the epidemic of its consequences (such as CVD and type 2 diabetes).

Compelling evidence from recent human studies has demonstrated that diet modifications are effective means in MetS management. Consumption of carbohydrate-rich foods such as rice affects blood glucose and influences diabetes risk. Specifically, eating polished white rice may increase diabetes risk, whereas eating brown rice, a whole grain product, may decrease risk. This is likely related to the different ability of white and brown rice to raise blood glucose levels, as measured by their glycemic index (GI) and glycemic load (GL), and to the higher levels of dietary fiber, vitamin B complex, magnesium and other micronutrients in brown rice.

A total of 200 participants with MetS (defined by ATP-III criteria) will be randomly assigned to a brown rice diet or an isocaloric white rice diet for 16 weeks. Effects of substituting brown for white rice will be evaluated by measuring metabolic profile (BMI, blood pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin, HbA1C).

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Institute for Nutritional Sciences, Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The updated National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria for the diagnosis of the MetS will be used. MetS will be defined with at least three of the following abnormalities:

  • central obesity (defined as waist circumference ≥ 80 cm for women or ≥ 90 cm for men)
  • Raised triglycerides level: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality;
  • Reduced HDL cholesterol: < 40 mg/dL (1.0 mmol/L) in males and < 50 mg/dL (1.3 mmol/L) in females, or specific treatment for this lipid abnormality;
  • Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension;
  • Increased fasting plasma glucose (FPG): ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.
• Being able to comply with the specified feeding conditions
• Being able to eat brown rice
• Being between the ages of 35 and 60 years

Exclusion Criteria:

• Pregnancy or lactation
• Use of insulin
• Severe kidney disease
• Cardiovascular diseases, stroke, cancer and psychological disorders
• Brown rice allergies
• Drug or alcohol abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Brown rice	Dietary supplement: Brown rice/White rice; ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks
PLACEBO_COMPARATOR: B; White rice	Dietary supplement: Brown rice/White rice; ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fasting glucose	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
blood pressure	16 weeks
HbA1c	16 weeks
Insulin	16 weeks
total cholesterol	16 weeks
triglyceride	16 weeks
LDL-C	16 weeks
HDL-C	16 weeks

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Harvard School of Public Health (HSPH)

Publications and helpful links

General Publications

• Zhang G, Pan A, Zong G, Yu Z, Wu H, Chen X, Tang L, Feng Y, Zhou H, Chen X, Li H, Hong B, Malik VS, Willett WC, Spiegelman D, Hu FB, Lin X. Substituting white rice with brown rice for 16 weeks does not substantially affect metabolic risk factors in middle-aged Chinese men and women with diabetes or a high risk for diabetes. J Nutr. 2011 Sep;141(9):1685-90. doi: 10.3945/jn.111.142224. Epub 2011 Jul 27.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (ESTIMATE): December 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2010
• Last Update Submitted That Met QC Criteria: October 20, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: diabetes risk; white rice; brown rice
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: KSCX1-YW-02-BR