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: In preliminary animal experiments, we found that the soybean isoflavone compound Genistein could reduce serum TMAO levels in high-fat diet (HFD) mice, and this effect was dependent on the gut microbiota. Furthermore, we discovered that Genistein's regulatory effect on the gut microbiota in high-fat diet mice relies on the host colonic PKI-Nos2 pathway. Genistein is an isoflavone compound extracted from soybeans and is the most effective functional ingredient in soybean isoflavone products. It has multiple physiological functions, and several randomized controlled trials (RCTs) have shown that the intake of Genistein can effectively alleviate hyperlipidemia, obesity, metabolic syndrome, and cardiovascular diseases, suggesting its safety and efficacy as a clinical health supplement. Therefore, we aim to conduct clinical trials to further demonstrate that Genistein also influences the gut microbiota in hyperlipidemia patients, thereby reducing serum TMAO levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genistein | Experimental | Dietary Supplement: Genistein Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day. |
|
| Control | No Intervention | The control group does not take the Genistein medication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genistein | Dietary Supplement | Hyperlipidemia patients take a 125mg Genistein capsule daily, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum TMAO level | 12 months | |
| Fecal TMA level | 12 months | |
| Microbial flora structure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum CHOL level | 12 months | |
| Serum TG level | 12 months | |
| Serum LDLC level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Hospital of Southern Medical University | Guangzhou | Guangdong | 0086510282 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019833 | Genistein |
| ID | Term |
|---|---|
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| 12 months |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |