Artichoke and Bergamot Phytosome

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Combination Product: Placebo; Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract

• Registration Number: NCT04697121
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-21
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-16
• Study First Submitted: 2020-12-29
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Combined Bergamot Phytosome and Artichoke leaf dry extract	Combined Bergamot phytosome and Artichoke leaf dry extract	600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract

Primary Outcome Measures

Name	Time	Method
Changes of lipid parameters	Baseline / 30 days / 60 days	Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)

Secondary Outcome Measures

Name	Time	Method
Changes of lipid parameters	Baseline / 30 days / 60 days	apolipoprotein A, apolipoprotein B, triglycerides (mg/dl)
Changes of anthropometric measurements	Baseline / 30 days / 60 days	waist circumference (cm)
Changes of metabolic parameters	Baseline / 30 days / 60 days	Glycated Hemoglobin (percent)
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	Creatinine (mg/dl)

Trial Locations

Locations (1)

Azienda di Servizi alla Persona; 🇮🇹 Pavia, Italy