Effect of Brown Rice on the Risk Factors for Metabolic Syndrome

Tufts University

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Other: White rice

Other: Brown rice

Study type

Interventional

Funder types

Other

Identifiers

NCT02321553

11066

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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