Clinical trial NCT01022411: Brown Rice Intervention on Metabolic Syndrome (BRIMS)
Official title: A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome X
Keywords: brown rice
white rice
diabetes risk
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2009-12-01
Enrollment: 202
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: fasting glucose
timeFrame: 16 weeks
Secondary outcomes:
measure: Insulin
timeFrame: 16 weeks
measure: total cholesterol
timeFrame: 16 weeks
measure: triglyceride
timeFrame: 16 weeks
measure: LDL-C
timeFrame: 16 weeks
measure: HDL-C
timeFrame: 16 weeks
measure: blood pressure
timeFrame: 16 weeks
measure: HbA1c
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute for Nutritional Sciences, Chinese Academy of Sciences
Study officials:
affiliation: Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
name: Xu Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.