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Effect of Brown Rice on the Risk Factors for Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brown rice

White rice

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring metabolic syndrome, glucose, cholesterol, brown rice, inflammation, oxidative stress

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Clinical and Translation Research Center, Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Brown Rice

White Rice

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glucoregulation (glucose, insulin and HbA1c)

Secondary Outcome Measures

Inflammatory markers (high sensitivity CRP, soluble intercellular adhesion molecule 1, serum amyloid A, vascular cell adhesion molecule 1)

Lipid profile (Total cholesterol, HDL and Triglycerides)

Oxidative stress markers - total antioxidant potential (TAP), total thiols, tocols, Ferric Reducing Antioxidant Power (FRAP), malondialdehyde (MDA), uric acid

Full Information

NCT ID

NCT02321553

First Posted

December 10, 2014

Last Updated

May 13, 2015

Sponsor

Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT02321553

Brief Title

Effect of Brown Rice on the Risk Factors for Metabolic Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tufts University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brown Rice

Arm Type

Experimental

Arm Description

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

Arm Title

White Rice

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Brown rice

Intervention Description

brown rice cake

Intervention Type

Other

Intervention Name(s)

White rice

Intervention Description

white rice cake

Primary Outcome Measure Information:

Title

Glucoregulation (glucose, insulin and HbA1c)

Time Frame

Change from baseline after 5 week intervention phase

Secondary Outcome Measure Information:

Title

Inflammatory markers (high sensitivity CRP, soluble intercellular adhesion molecule 1, serum amyloid A, vascular cell adhesion molecule 1)

Time Frame

Change from baseline after 5 week intervention phase

Title

Lipid profile (Total cholesterol, HDL and Triglycerides)

Time Frame

Change from baseline after 5 week intervention phase

Title

Oxidative stress markers - total antioxidant potential (TAP), total thiols, tocols, Ferric Reducing Antioxidant Power (FRAP), malondialdehyde (MDA), uric acid

Time Frame

Change from baseline after 5 week intervention phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Chen, Ph.D.

Organizational Affiliation

Tufts University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical and Translation Research Center, Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

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Effect of Brown Rice on the Risk Factors for Metabolic Syndrome

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