Artichoke and Bergamot Phytosome

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract; Combination Product: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04697121

0921/22052019

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Combination Product: Placebo

Combined Bergamot Phytosome and Artichoke leaf dry extract

Active Comparator group

Description:

600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract

Treatment:

Dietary Supplement: Combined Bergamot phytosome and Artichoke leaf dry extract