Artichoke and Bergamot Phytosome

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697121
• Other study ID #: 0921/22052019
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: July 16, 2020

Study information

• Verified date: January 2021
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 16, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Combined 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 Product:
• Placebo
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of lipid parameters	Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)	Baseline / 30 days / 60 days
Secondary	Changes of lipid parameters	apolipoprotein A, apolipoprotein B, triglycerides (mg/dl)	Baseline / 30 days / 60 days
Secondary	Changes of metabolic parameters	Fasting blood glucose (mg/dl)	Baseline / 30 days / 60 days
Secondary	Changes of metabolic parameters	Glycated Hemoglobin (percent)	Baseline / 30 days / 60 days
Secondary	Changes of anthropometric measurements	Weight (kg) and height (m) were combined to report BMI in kg/m^2	Baseline / 30 days / 60 days
Secondary	Changes of anthropometric measurements	waist circumference (cm)	Baseline / 30 days / 60 days
Secondary	Changes of body composition	Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)	Baseline / 30 days / 60 days
Secondary	Changes of safety parameters	Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l)	Baseline / 30 days / 60 days
Secondary	Changes of safety parameters	Gamma Glutamyl Transferase (U/l)	Baseline / 30 days / 60 days
Secondary	Changes of safety parameters	Creatinine (mg/dl)	Baseline / 30 days / 60 days