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| Name | Class |
|---|---|
| Indena S.p.A | INDUSTRY |
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Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator |
| |
| Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 mg of artichoke extract | Dietary Supplement | Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on glycemia | Day 0, after 1 month and after 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes on total cholesterol (mg/dl), HDL (mg/dl), total cholesterol/HLD, LDL (mg/dl), LDL/HDL, triglycerides (mg/dl), ApoA (mg/dl), ApoB (mg/dl), ApoB/ApoA, creatinine (mg/dl) | Day 0, after 1 month and after 2 months | |
| Changes on AST (UI/l), ALT (UI/l), GGT (U/l) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda di Servizi alla Persona ''Istituto Santa Margherita'' | Pavia | PV | 27100 | Italy |
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| Placebo | Other | Tablets with no active ingredient |
|
| Day 0, after 1 month and after 2 months |
| Changes on insulin (mcU/ml) and HOMA index | Day 0, after 1 month and after 2 months |
| Changes on glycated hemoglobin (%) | Day 0, after 1 month and after 2 months |
| Changes on A1c-Derived Average Glucose (mmol/l) | Day 0, after 1 month and after 2 months |
| Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg) | Day 0, after 1 month |
| Changes on waist circumference (cm) | Day 0, after 1 month |
| Changes on VAT (g), lean and fat mass (g) | Day 0, after 1 month |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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