The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome

NCT02407522 | Completed Phase 2

• 1 other identifier: SunYat-senU001
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome X

Keywords

Metabolic Syndrome; black rice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• proportion of Bacteroides

  3months

• proportion of Bifidobacterium

  3months

Other Outcomes (5)

• changes in fasting blood-glucose

  3 months

• changes in fasting total triglyceride

  3 months

• changes in fasting HDL-c

  3 months

Study Arms (2)

black rice group

EXPERIMENTAL

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

white rice group

PLACEBO COMPARATOR

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

Interventions

Black rice DIETARY_SUPPLEMENT

They asked to keep their normal life style during intervention

black rice group

follow-up OTHER

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.

white rice group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ling wenhua, profess

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 3, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 3, 2015

Record last verified: 2015-03