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

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ClinicalTrials.gov Identifier: NCT01022411
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : October 21, 2010
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by:
Chinese Academy of Sciences

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date October 21, 2010
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
fasting glucose [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
fasting glucose and insulin [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • Insulin [ Time Frame: 16 weeks ]
  • total cholesterol [ Time Frame: 16 weeks ]
  • triglyceride [ Time Frame: 16 weeks ]
  • LDL-C [ Time Frame: 16 weeks ]
  • HDL-C [ Time Frame: 16 weeks ]
  • blood pressure [ Time Frame: 16 weeks ]
  • HbA1c [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
Total cholesterol, triglyceride, HDL-C, HbA1C, blood pressure, CRP, IL-6, adiponectin [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brown Rice Intervention on Metabolic Syndrome (BRIMS)
Official Title  ICMJE A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome X
Intervention  ICMJE Dietary Supplement: Brown rice/White rice
ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks
Study Arms  ICMJE
  • Experimental: A
    Brown rice
    Intervention: Dietary Supplement: Brown rice/White rice
  • Placebo Comparator: B
    White rice
    Intervention: Dietary Supplement: Brown rice/White rice
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2010)
202
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
200
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022411
Other Study ID Numbers  ICMJE KSCX1-YW-02-BR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xu Lin, Principal Investigator, Institute for Nutritional Sciences, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE Harvard School of Public Health
Investigators  ICMJE
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
PRS Account Chinese Academy of Sciences
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP