Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
According to WHO data, about 50% of deaths each year are caused by cardiovascular disease. One of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. The aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. The study was a 8-week randomized double-blind placebo-controlled trial. Participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Combined Bergamot Phytosome and Artichoke leaf dry extract | Active Comparator | 600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Bergamot phytosome and Artichoke leaf dry extract | Dietary Supplement | 600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract. Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of lipid parameters | Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl) | Baseline / 30 days / 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of lipid parameters | apolipoprotein A, apolipoprotein B, triglycerides (mg/dl) | Baseline / 30 days / 60 days |
| Changes of metabolic parameters | Fasting blood glucose (mg/dl) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda di Servizi alla Persona | Pavia | 27100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Combination Product | Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks. |
|
| Baseline / 30 days / 60 days |
| Changes of metabolic parameters | Glycated Hemoglobin (percent) | Baseline / 30 days / 60 days |
| Changes of anthropometric measurements | Weight (kg) and height (m) were combined to report BMI in kg/m^2 | Baseline / 30 days / 60 days |
| Changes of anthropometric measurements | waist circumference (cm) | Baseline / 30 days / 60 days |
| Changes of body composition | Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g) | Baseline / 30 days / 60 days |
| Changes of safety parameters | Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l) | Baseline / 30 days / 60 days |
| Changes of safety parameters | Gamma Glutamyl Transferase (U/l) | Baseline / 30 days / 60 days |
| Changes of safety parameters | Creatinine (mg/dl) | Baseline / 30 days / 60 days |
| D009750 |
| Nutritional and Metabolic Diseases |