Brown Rice Intervention on Metabolic Syndrome (BRIMS)

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Dietary Supplement: Brown rice/White rice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Brown rice | Dietary Supplement: Brown rice/White rice<br>* ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks<br>|
| Placebo Comparator: B<br>White rice | Dietary Supplement: Brown rice/White rice<br>* ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glucose |  | 16 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brown rice, white rice, diabetes risk