Effect of Brown Rice on the Risk Factors for Metabolic Syndrome

NCT02321553 | Completed

• 1 other identifier: 11066
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; glucose; cholesterol; brown rice; inflammation; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Glucoregulation (glucose, insulin and HbA1c)

  Change from baseline after 5 week intervention phase

Secondary Outcomes (3)

• 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

Study Arms (2)

Brown Rice

EXPERIMENTAL

Eat 100g of brown rice cake (3 packets) per day for 5 weeks

Other: Brown rice

White Rice

EXPERIMENTAL

Eat 100g of white rice cake (3 packets) per day for 5 weeks

Other: White rice

Interventions

Brown rice OTHER

brown rice cake

Brown Rice

White rice OTHER

white rice cake

White Rice

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Clinical and Translation Research Center, Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oliver Chen, Ph.D.

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist I

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 22, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

US (1)