The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

— IDSBRMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407522
• Other study ID #: SunYat-senU001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 26, 2015
• Last updated: April 2, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Black rice
They asked to keep their normal life style during intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in fasting blood-glucose	(after intervention - baseline)/baseline×100%	3 months	No
Other	changes in fasting total triglyceride	(after intervention - baseline)/baseline×100%	3 months	No
Other	changes in fasting HDL-c	(after intervention - baseline)/baseline×100%	3 months	No
Other	changes in fasting LDL-c	(after intervention - baseline)/baseline×100%	3 months	No
Other	changes in fasting waistline	(after intervention - baseline)/baseline×100%	3 months	No
Primary	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	No
Secondary	proportion of Bacteroides	PCR analysis the RNA of Bacteroides in faeces	3months	No
Secondary	proportion of Bifidobacterium	PCR analysis the RNA of Bacteroides in faeces	3months	No