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| Name | Class |
|---|---|
| University of Catania | OTHER |
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Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.
This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.
The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.
All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement | Experimental | 50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die) |
|
| Placebo | Placebo Comparator | 50 subjects with the metabolic syndrome receiving placebo (without any active ingredients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural supplement containing chlorogenic acid and luteolin | Dietary Supplement | 50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI) | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m^2. | Change from baseline to 6 months of the supplementation |
| Effect of natural supplement on metabolic parameters including waist circumference | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm). | Change from baseline to 6 months of the supplementation |
| Effect of natural supplement on metabolic parameters including plasma lipids | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula. | Change from baseline to 6 months of the supplementation |
| Effect of natural supplement on metabolic parameters including glucose metabolism parameters | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l). | Change from baseline to 6 months of the supplementation |
| Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index. | Change from baseline to 6 months of the supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of natural supplement on cardio-metabolic parameters including plasma cytokines | Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including plasma cytokines (inflammatory markers and adipokines) (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits. | Change from baseline to 6 months of the supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfredi Rizzo, MD, PhD | University Hospital of Palermo, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Palermo | Palermo | Palrmo | 90127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19805654 | Background | Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5. |
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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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| ID | Term |
|---|---|
| D047311 | Luteolin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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placebo-controlled study
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double-blind study
|
| Placebo (without any active ingredients) | Other | 50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study. |
|
| Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins | Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including atherogenic lipoproteins as well as the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis. | Change from baseline to 6 months of the supplementation |
| Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis | Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm). | Change from baseline to 6 months of the supplementation |
| Effect of natural supplement on cardio-metabolic parameters including fatty liver index | Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including fatty liver index, a noninvasive method used for steatosis detection and quantification. | Change from baseline to 6 months of the supplementation |
| D009750 |
| Nutritional and Metabolic Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |