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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Dietary supplement: Black rice; Other: follow-up

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: black rice group; 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.	Dietary supplement: Black rice; They asked to keep their normal life style during intervention
Placebo Comparator: white rice group; 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.	Other: follow-up; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of Bacteroides	PCR analysis the RNA of Bacteroides in faeces	3months
proportion of Bifidobacterium	PCR analysis the RNA of Bacteroides in faeces	3months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in fasting blood-glucose	(after intervention - baseline)/baseline×100%	3 months
changes in fasting total triglyceride	(after intervention - baseline)/baseline×100%	3 months
changes in fasting HDL-c	(after intervention - baseline)/baseline×100%	3 months
changes in fasting LDL-c	(after intervention - baseline)/baseline×100%	3 months
changes in fasting waistline	(after intervention - baseline)/baseline×100%	3 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Ling wenhua, profess, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Metabolic Syndrome; black rice
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: SunYat-senU001