Hypercholesterolemia
Conditions
Keywords
bergamot, Cynara cardunculus
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTCombined Bergamot phytosome and Artichoke leaf dry extract
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.
COMBINATION_PRODUCTPlacebo
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* mild hypercholesterolemia (220 - 280 mg/dl) * subjects were not taking any medication likely to affect lipid metabolism (such as statins) * subjects were bergamot poor-responders
Exclusion criteria
* liver, renal and thyroid diseases * history of cardiovascular disease (CVD)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of lipid parameters | Baseline / 30 days / 60 days | Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of lipid parameters | Baseline / 30 days / 60 days | apolipoprotein A, apolipoprotein B, triglycerides (mg/dl) |
| Changes of metabolic parameters | Baseline / 30 days / 60 days | Fasting blood glucose (mg/dl) |
| Changes of anthropometric measurements | Baseline / 30 days / 60 days | Weight (kg) and height (m) were combined to report BMI in kg/m\^2 |
| Changes of body composition | Baseline / 30 days / 60 days | Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g) |
| Changes of safety parameters | Baseline / 30 days / 60 days | Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l) |
Countries
Italy
Outcome results
None listed