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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

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).

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Dietary Supplement: Brown rice/White rice Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. fasting glucose [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Insulin [ Time Frame: 16 weeks ]
  2. total cholesterol [ Time Frame: 16 weeks ]
  3. triglyceride [ Time Frame: 16 weeks ]
  4. LDL-C [ Time Frame: 16 weeks ]
  5. HDL-C [ Time Frame: 16 weeks ]
  6. blood pressure [ Time Frame: 16 weeks ]
  7. HbA1c [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022411


Locations
China
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, China
Sponsors and Collaborators
Chinese Academy of Sciences
Harvard School of Public Health
Investigators
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xu Lin, Principal Investigator, Institute for Nutritional Sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT01022411     History of Changes
Other Study ID Numbers: KSCX1-YW-02-BR
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: October 2010

Keywords provided by Chinese Academy of Sciences:
brown rice
white rice
diabetes risk

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases