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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
Azienda di Servizi alla Persona
Pavia, Italy
Changes of lipid parameters
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)
Time frame: Baseline / 30 days / 60 days
Changes of lipid parameters
apolipoprotein A, apolipoprotein B, triglycerides (mg/dl)
Time frame: Baseline / 30 days / 60 days
Changes of metabolic parameters
Fasting blood glucose (mg/dl)
Time frame: Baseline / 30 days / 60 days
Changes of metabolic parameters
Glycated Hemoglobin (percent)
Time frame: Baseline / 30 days / 60 days
Changes of anthropometric measurements
Weight (kg) and height (m) were combined to report BMI in kg/m\^2
Time frame: Baseline / 30 days / 60 days
Changes of anthropometric measurements
waist circumference (cm)
Time frame: Baseline / 30 days / 60 days
Changes of body composition
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
Time frame: Baseline / 30 days / 60 days
Changes of safety parameters
Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l)
Time frame: Baseline / 30 days / 60 days
Changes of safety parameters
Gamma Glutamyl Transferase (U/l)
Time frame: Baseline / 30 days / 60 days
Changes of safety parameters
Creatinine (mg/dl)
Time frame: Baseline / 30 days / 60 days
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