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Metabolic Syndrome XPhase 2/3BRIMSNCT01022411

Brown Rice Intervention on Metabolic Syndrome (BRIMS)

A Phase 2/3 study testing Brown rice/White rice in people with Metabolic Syndrome X, run by Chinese Academy of Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 35 to 60 years
Conditions the study is for
Metabolic Syndrome X
What is being tested?
Brown rice/White rice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
1 siteChina
Study dates
Oct 2009to Oct 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • Being able to comply with the specified feeding conditions
  • Being able to eat brown rice
  • Being between the ages of 35 and 60 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute for Nutritional Sciences, Chinese Academy of Sciences

    Shanghai

Other trials in China

About this study

Official title: A Randomized Prevention Trial Substituting Brown Rice for White Rice to Lower Markers for Diabetes Risk

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).

Being tested
Brown rice/White rice
Keywords
brown rice, white rice, diabetes risk
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brown rice/White riceDietary supplement

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

Study groups in NCT01022411
Study groupRoleWhat they receive
AExperimentalBrown rice
Receives: Dietary Supplement: Brown rice/White rice
BPlacebo comparatorWhite rice
Receives: Dietary Supplement: Brown rice/White rice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fasting glucose

    Measured: 16 weeks

Secondary outcomes (7)

  1. Insulin

    Measured: 16 weeks

  2. total cholesterol

    Measured: 16 weeks

  3. triglyceride

    Measured: 16 weeks

  4. LDL-C

    Measured: 16 weeks

  5. HDL-C

    Measured: 16 weeks

  6. blood pressure

    Measured: 16 weeks

  7. HbA1c

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJul 2010
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01022411
Sponsor's protocol ID
KSCX1-YW-02-BR
Acronym
BRIMS
Status last verified
Oct 2010
First submitted
30 Nov 2009
Last updated
21 Oct 2010
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Brown rice/White rice in people with Metabolic Syndrome X, run by Chinese Academy of Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting glucose (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01022411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2010.

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