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Bergavit is a product contains bergamot. Bergamot is an endemic plant of the Calabrian region in southern Italy with a unique profile of flavonoids and flavonoid glycosides present in its juice and albedo, its flavonoids was able to reduce serum levels of lipids and ameliorate the thickening of the arteries through modulating enzymatic activities, anti-oxidation, anti-inflammatory mechanisms and inhibition of monocyte activation and proliferation.The primary outcome of the study the assessment of the the hypolipidemic effect of Bergavit. The secondary outcomes are the assessment of: a) the hypoglycemic effect of Bergavit, b) the activity of Bergavit on weight loss, and c) the hepatoprotective activity of Bergavit.
The study duration is 4 months. Subjects will attend clinic visits as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bergavit | Experimental | Group Bergavit : 60 subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months. |
|
| Placebo | Placebo Comparator | Group Placebo: 60 subjects will take capsule equivalent amount of maltodextrin for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bergavit | Dietary Supplement | Subjects treated with Bergavit capsule intake of 150 mg/die of pure flavonoids for 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Changes of LDL-C of the Subjects. | A randomized-double blind trial. The values change of LDL-C between before to after 0, 8, 12, 10 & 16 weeks. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of Cholesterol of the Subjects. | A randomized-double blind trial. The values change of Cholesterol between before to after 0, 8, 12, 10 & 16 weeks. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Taichung | Taiwan |
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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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| Placebo | Dietary Supplement | Subjects will take capsule equivalent amount of maltodextrin for 4 months. |
|