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

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Brown rice/White rice
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring brown rice, white rice, diabetes risk

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Nutritional Sciences, Chinese Academy of Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Brown rice

White rice

Outcomes

Primary Outcome Measures

fasting glucose

Secondary Outcome Measures

Insulin
total cholesterol
triglyceride
LDL-C
HDL-C
blood pressure
HbA1c

Full Information

First Posted
November 30, 2009
Last Updated
October 20, 2010
Sponsor
Chinese Academy of Sciences
Collaborators
Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT01022411
Brief Title
Brown Rice Intervention on Metabolic Syndrome (BRIMS)
Acronym
BRIMS
Official Title
A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Harvard School of Public Health (HSPH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
brown rice, white rice, diabetes risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Brown rice
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
White rice
Intervention Type
Dietary Supplement
Intervention Name(s)
Brown rice/White rice
Intervention Description
ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks
Primary Outcome Measure Information:
Title
fasting glucose
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Insulin
Time Frame
16 weeks
Title
total cholesterol
Time Frame
16 weeks
Title
triglyceride
Time Frame
16 weeks
Title
LDL-C
Time Frame
16 weeks
Title
HDL-C
Time Frame
16 weeks
Title
blood pressure
Time Frame
16 weeks
Title
HbA1c
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Lin, MD, PhD
Organizational Affiliation
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Nutritional Sciences, Chinese Academy of Sciences
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
21795429
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.
Results Reference
derived

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Brown Rice Intervention on Metabolic Syndrome (BRIMS)

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