Brown Rice Intervention on Metabolic Syndrome (BRIMS)

NCT01022411 | Completed Phase 2

• 1 other identifier: KSCX1-YW-02-BR
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolic Syndrome X

Keywords

brown rice; white rice; diabetes risk

Outcome Measures

Primary Outcomes (1)

• fasting glucose

  16 weeks

Secondary Outcomes (7)

• Insulin

  16 weeks

• total cholesterol

  16 weeks

• triglyceride

  16 weeks

• LDL-C

  16 weeks

• HDL-C

  16 weeks

Study Arms (2)

A

EXPERIMENTAL

Brown rice

Dietary Supplement: Brown rice/White rice

B

PLACEBO COMPARATOR

White rice

Dietary Supplement: Brown rice/White rice

Interventions

Brown rice/White rice DIETARY_SUPPLEMENT

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

A; B

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation
• Use of insulin
• Severe kidney disease
• Cardiovascular diseases, stroke, cancer and psychological disorders
• Brown rice allergies
• Drug or alcohol abuse

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 21795429 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Xu Lin, MD, PhD

  Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 1, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 21, 2010

Record last verified: 2010-10

Locations

CN (1)