Effect of Brown Rice on the Risk Factors for Metabolic Syndrome

Biological Functions of Brown Rice on Metabolic Syndrome: A Randomized Cross-over Pilot Study

The purpose of the study is to determine the effect of consumption of brown rice on the risk factors of metabolic syndrome (MetS) as compared to consumption of white rice. Brown and white rice will be provided in the form of rice cakes and 100g will be consumed per day for 5 weeks each. The investigators hypothesize that brown rice will have beneficial effects as it is rich in fiber and also phytochemicals.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: Brown rice; Other: White rice

Detailed Description

This is a 2-way cross-over, randomized, placebo controlled, pilot feasibility study to determine the effect of brown rice on the risk factors of metabolic syndrome (MetS). Eligible subjects (n = 9) with the MetS (>50 yr, post-menopausal women and men) will be randomized to receive either brown rice cakes (100 g/d) as treatment or white rice cake as placebo during each 5-wk intervention phase with a 2-wk washout between phases. Subjects will visit Tufts Medical Center for all study visits, at the end of baseline (first 2 week run in phase) and weeks 7, 9 and 14, which will include a 12 hour fasting blood draw. Two sets of three 24 hour dietary recalls will be conducted during the intervention phases. Fasting blood samples will be analyzed for 1) oxidative stress markers (vitamin E concentrations, total antioxidant capacity, and lipid peroxidation product), 2) blood lipid profiles and 3) metabolic risk factors such as plasma glucose, insulin, inflammatory cytokines.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Clinical and Translation Research Center, Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men & postmenopausal women, aged >50 years
• BMI >30 kg/m2 and/or waist/hip ratio >0.9 for men, >0.85 for women
• plus any two of the following four MetS factors
• Fasting plasma TG: 150-400 mg/dL (1.7 - 4.52 mmol/L)
• Fasting plasma HDL cholesterol: <40 mg /dL (1.03 mmol/L) for men, <50 mg/dL (1.29 mmol/L) for women
• Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg
• Fasting plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no medication for blood glucose regulation and no use of insulin

Exclusion Criteria:

• Cigarette smoking and/or nicotine replacement use
• Individuals taking estrogen
• Use of blood glucose lowering medications or insulin
• Regular use (>2x/wk) of any stomach acid-lowering medications or laxatives
• Regular use (>2x/wk) of medication for inflammation
• Regular use of medication for hypercoagulation
• Cardiovascular (heart) disease
• Gastrointestinal disease
• Renal or chronic kidney disease
• Endocrine disease: including diabetes, untreated thyroid disease
• Rheumatoid arthritis
• Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
• Systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg
• Regular use of oral steroids except topical OTC steroids
• Regular daily intake of ≥2 alcoholic drinks
• Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
• Illicit drug use
• Vegetarians
• No fish oil supplements (including cod liver oil) for one month prior to study admission
• No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission
• On or planning a weight reducing regimen using a dietary approach of dietary supplements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brown Rice; Eat 100g of brown rice cake (3 packets) per day for 5 weeks	Other: Brown rice; brown rice cake
Experimental: White Rice; Eat 100g of white rice cake (3 packets) per day for 5 weeks	Other: White rice; white rice cake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glucoregulation (glucose, insulin and HbA1c)	Change from baseline after 5 week intervention phase

Secondary Outcome Measures

Outcome Measure	Time Frame
Inflammatory markers (high sensitivity CRP, soluble intercellular adhesion molecule 1, serum amyloid A, vascular cell adhesion molecule 1)	Change from baseline after 5 week intervention phase
Lipid profile (Total cholesterol, HDL and Triglycerides)	Change from baseline after 5 week intervention phase
Oxidative stress markers - total antioxidant potential (TAP), total thiols, tocols, Ferric Reducing Antioxidant Power (FRAP), malondialdehyde (MDA), uric acid	Change from baseline after 5 week intervention phase

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Oliver Chen, Ph.D., Tufts University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: inflammation; oxidative stress; metabolic syndrome; glucose; cholesterol; brown rice
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 11066