Artichoke and Bergamot Phytosome

Study Overview
=================
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).

Official Title
-----------------
Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract
* Combination Product: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Combination Product: Placebo<br>* Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.<br>|
| Active Comparator: Combined Bergamot Phytosome and Artichoke leaf dry extract<br>600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract | Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of lipid parameters | Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl) | Baseline / 30 days / 60 days | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bergamot, Cynara cardunculus