The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

Phase 2

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Dietary Supplement: Black rice; Other: follow-up

• Registration Number: NCT02407522
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-03
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
black rice group	Black rice	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.
white rice group	follow-up	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.

Primary Outcome Measures

Name	Time	Method
reversal rate of metabolic syndrome	3 months	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

Name	Time	Method
proportion of Bacteroides	3months	PCR analysis the RNA of Bacteroides in faeces
proportion of Bifidobacterium	3months	PCR analysis the RNA of Bacteroides in faeces