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CompletedNCT01022411BRIMSUpdated Oct 21, 2010

Brown Rice Intervention on Metabolic Syndrome (BRIMS)

A Phase 2/3 interventional study of Brown rice/White rice in Metabolic Syndrome X, sponsored by Chinese Academy of Sciences. Completed at 1 site in China. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-10-21.

Sponsored by Chinese Academy of Sciences · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
202
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Metabolic Syndrome X

Keywords

  • brown rice
  • white rice
  • diabetes risk
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 202 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Chinese Academy of Sciences is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
202 participants (actual)

Study arms

  • Experimental
    A

    Brown rice

    Dietary Supplement: Brown rice/White rice

  • Placebo comparator
    B

    White rice

    Dietary Supplement: Brown rice/White rice

Interventions

  • Dietary supplementBrown rice/White rice

    ad libitum intake of brown rice/white rice at every lunch and dinner for 16 weeks

06

What researchers measure

Primary outcomes

  1. fasting glucose

    Time frame: 16 weeks

Secondary outcomes

  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

07

Study locations

1 site
  • Institute for Nutritional Sciences, Chinese Academy of Sciences
    Shanghai, China
08

References and documents

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. PubMed 21795429 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01022411
Lead sponsor
Chinese Academy of Sciences
Collaborators
Harvard School of Public Health (HSPH)
First posted
Dec 1, 2009
Start date
Oct 2009
Primary completion
Jul 2010
Completion
Oct 2010
Last update
Oct 21, 2010

Study contacts

Xu Lin, MD, PhD
principal investigator · Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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