Brown Rice Intervention on Metabolic Syndrome (BRIMS)

Metabolic Syndrome X Clinical Trial

— BRIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022411
• Other study ID #: KSCX1-YW-02-BR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 30, 2009
• Last updated: October 20, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X

Intervention

Dietary Supplement:
• Brown rice/White rice
ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks

Locations

Country	Name	City	State
China	Institute for Nutritional Sciences, Chinese Academy of Sciences	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Harvard School of Public Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting glucose		16 weeks	No
Secondary	Insulin		16 weeks	No
Secondary	total cholesterol		16 weeks	No
Secondary	triglyceride		16 weeks	No
Secondary	LDL-C		16 weeks	No
Secondary	HDL-C		16 weeks	No
Secondary	blood pressure		16 weeks	No
Secondary	HbA1c		16 weeks	No