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The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome (IDSBRMS)

Primary Purpose

Metabolic Syndrome X

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Black rice

follow-up

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Metabolic Syndrome, black rice

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

individuals meeting at least 3 of the following 5 criteria will be chosen:
abdominal obesity: using the waist standard for Asians: waist≥90 for male and ≥80 for female
high blood sugar: fasting plasma glucose≥5.6mmol/L (100mg/d L) or individuals diagnosed with diabetes and being treated
hypertension: systolic blood pressure≥130 mm Hg or diastolic blood pressure≥85 mm Hg or individuals diagnosed with hypertension and being treated
dyslipidemia: fasting total triglycerides≥1.70 mmol/L(150 mg/d L) or individuals undergoing lipid-lowering therapy
fasting plasma high-density lipoprotein cholesterol<1.03mmol/L (40mg/dL) for male or <1.3mmol/L (50mg/dL) for female.

Exclusion Criteria:

having current or former cardiovascular disease, including coronary heart disease (e.g., angina pectoris, myocardial infarction, coronary revascularization, abnormal Q waves in ECG), stroke (e.g., congestive, hemorrhagic, or transient ischemic stroke), and intermittent claudication caused by peripheral arterial diseases;
severe clinical conditions that may compromise patients' participation in experiments, e.g., digestive diseases leading to inability to maintain black rice uptake, patients receiving parenteral nutrition supply, malignancies in progress, and mental illness;
immunodeficiency disease or AIDS, chronic inflammation conditions
drug abuse or alcoholism (>80g/d).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

black rice group

white rice group

Arm Description

Each subject in the experimental group will be provided with black rice (50 g/day).According to the clinical requirements, no specific rules are needed for other treatments of the two groups.

individuals in the control group will be subjected to follow-up. According to the clinical requirements, no specific rules are needed for other treatments of the two groups.

Outcomes

Primary Outcome Measures

reversal rate of metabolic syndrome

Numerator is number of people is metabolic syndrome at baseline but not after intervention. The denominator is the overall number of people in the group

Secondary Outcome Measures

proportion of Bacteroides

PCR analysis the RNA of Bacteroides in faeces

proportion of Bifidobacterium

PCR analysis the RNA of Bacteroides in faeces

Full Information

NCT ID

NCT02407522

First Posted

March 26, 2015

Last Updated

April 2, 2015

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02407522

Brief Title

The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

Acronym

IDSBRMS

Official Title

The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome and Its Correlation With Metabolism of Gut Microbiota

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to thoroughly investigate how the interaction between black rice and human gut microbiota affects metabolic diseases, this study will recruit patients with Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50 g/day) for 3 months to observe its effect on the development of MS. The focuses of this project are to elucidate how black rice consumption affects the composition and metabolism of intestinal bacteria as well as the development of MS, and to further analyze whether the changes in intestinal bacteria are associated with the changes in MS improvements.

6. Conditions and Keywords

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

Metabolic Syndrome X

Keywords

Metabolic Syndrome, black rice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

black rice group

Arm Type

Experimental

Arm Description

Each subject in the experimental group will be provided with black rice (50 g/day).According to the clinical requirements, no specific rules are needed for other treatments of the two groups.

Arm Title

white rice group

Arm Type

Placebo Comparator

Arm Description

individuals in the control group will be subjected to follow-up. According to the clinical requirements, no specific rules are needed for other treatments of the two groups.

Intervention Type

Dietary Supplement

Intervention Name(s)

Black rice

Intervention Description

They asked to keep their normal life style during intervention

Intervention Type

Other

Intervention Name(s)

follow-up

Intervention Description

They asked not to consume any black rice or excess amount of food rich in anthocyanin compared to their normal life style, such as grapes, blueberry, red wine, black bean during intervention.

Primary Outcome Measure Information:

Title

reversal rate of metabolic syndrome

Description

Numerator is number of people is metabolic syndrome at baseline but not after intervention. The denominator is the overall number of people in the group

Time Frame

3 months

Secondary Outcome Measure Information:

Title

proportion of Bacteroides

Description

PCR analysis the RNA of Bacteroides in faeces

Time Frame

3months

Title

proportion of Bifidobacterium

Description

PCR analysis the RNA of Bacteroides in faeces

Time Frame

3months

Other Pre-specified Outcome Measures:

Title

changes in fasting blood-glucose

Description