Clinical trial NCT02407522: The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome
Official title: The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome and Its Correlation With Metabolism of Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome X
Keywords: Metabolic Syndrome
black rice
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 101
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: reversal rate of metabolic syndrome
timeFrame: 3 months
Secondary outcomes:
measure: proportion of Bacteroides
timeFrame: 3months
measure: proportion of Bifidobacterium
timeFrame: 3months
Other outcomes:
measure: changes in fasting blood-glucose
timeFrame: 3 months
measure: changes in fasting total triglyceride
timeFrame: 3 months
measure: changes in fasting HDL-c
timeFrame: 3 months
measure: changes in fasting LDL-c
timeFrame: 3 months
measure: changes in fasting waistline
timeFrame: 3 months
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Ling wenhua, profess
role: STUDY_DIRECTOR
References: