The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome (IDSBRMS)
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Black rice
follow-up
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Metabolic Syndrome, black rice
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
black rice group
white rice group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
proportion of Bacteroides
PCR analysis the RNA of Bacteroides in faeces
proportion of Bifidobacterium
PCR analysis the RNA of Bacteroides in faeces
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02407522
Brief Title
The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome
Acronym
IDSBRMS
Official Title
The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome and Its Correlation With Metabolism of Gut Microbiota
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Metabolic Syndrome, black rice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
black rice group
Arm Type
Experimental
Arm Description
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.
Arm Title
white rice group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Black rice
Intervention Description
They asked to keep their normal life style during intervention
Intervention Type
Other
Intervention Name(s)
follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
reversal rate of metabolic syndrome
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
proportion of Bacteroides
Description
PCR analysis the RNA of Bacteroides in faeces
Time Frame
3months
Title
proportion of Bifidobacterium
Description
PCR analysis the RNA of Bacteroides in faeces
Time Frame
3months
Other Pre-specified Outcome Measures:
Title
changes in fasting blood-glucose
Description
(after intervention - baseline)/baseline×100%
Time Frame
3 months
Title
changes in fasting total triglyceride
Description
(after intervention - baseline)/baseline×100%
Time Frame
3 months
Title
changes in fasting HDL-c
Description
(after intervention - baseline)/baseline×100%
Time Frame
3 months
Title
changes in fasting LDL-c
Description
(after intervention - baseline)/baseline×100%
Time Frame
3 months
Title
changes in fasting waistline
Description
(after intervention - baseline)/baseline×100%
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling wenhua, profess
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
12. IPD Sharing Statement
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The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome
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