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| Name | Class |
|---|---|
| Taipei Medical University WanFang Hospital | OTHER |
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This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract (IRK-19®) on weight management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo capsule |
|
| Treatment | Experimental | IRK-19 capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pumpkin seed extract (IRK-19) | Dietary Supplement | Placebo: Dietary fiber powder, two capsules/day (600 mg/day), continued use for 3 months Treatment: Pumpkin seed extract powder, two capsules/day (600 mg/day), continued use for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measurement | Body weight | Week 0 |
| Anthropometric measurement | Body weight | Week 6 |
| Anthropometric measurement | Body weight | Week 12 |
| Anthropometric measurement | Waist circumference | Week 0 |
| Anthropometric measurement | Waist circumference | Week 6 |
| Anthropometric measurement | Waist circumference | Week 12 |
| Anthropometric measurement | Hip circumference | Week 0 |
| Anthropometric measurement | Hip circumference | Week 6 |
| Anthropometric measurement | Hip circumference | Week 12 |
| Body composition analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yen-Nung Lin, MD | WanFang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WanFang Hospital | Taipei | 116 | Taiwan |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Body fat |
| Week 0 |
| Body composition analysis | Body fat | Week 6 |
| Body composition analysis | Body fat | Week 12 |
| Body composition analysis | Visceral fat | Week 0 |
| Body composition analysis | Visceral fat | Week 6 |
| Body composition analysis | Visceral fat | Week 12 |
| Body composition analysis | Subcutaneous fat | Week 0 |
| Body composition analysis | Subcutaneous fat | Week 6 |
| Body composition analysis | Subcutaneous fat | Week 12 |
| Biochemistry | Total cholesterol | Week 0 |
| Biochemistry | Total cholesterol | Week 6 |
| Biochemistry | Total cholesterol | Week 12 |
| Biochemistry | Triacylglycerol | Week 0 |
| Biochemistry | Triacylglycerol | Week 6 |
| Biochemistry | Triacylglycerol | Week 12 |
| Biochemistry | HDL | Week 0 |
| Biochemistry | HDL | Week 6 |
| Biochemistry | HDL | Week 12 |
| Biochemistry | LDL | Week 0 |
| Biochemistry | LDL | Week 6 |
| Biochemistry | LDL | Week 12 |
| Biochemistry | Adiponectin | Week 0 |
| Biochemistry | Adiponectin | Week 6 |
| Biochemistry | Adiponectin | Week 12 |
| Biochemistry | Lectin | Week 0 |
| Biochemistry | Lectin | Week 6 |
| Biochemistry | Lectin | Weeks 12 |
| Biochemistry | Fasting blood glucose | Week 0 |
| Biochemistry | Fasting blood glucose | Week 6 |
| Biochemistry | Fasting blood glucose | Week 12 |
| Biochemistry | Insulin | Week 0 |
| Biochemistry | Insulin | Week 6 |
| Biochemistry | Insulin | Week 12 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |