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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black rice | Dietary Supplement | They asked to keep their normal life style during intervention |
|
| 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 |
| 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 |
| 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% |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ling wenhua, profess | Sun Yat-sen University | Study Director |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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. |
|
| 3months |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |