Artichoke and Bergamot Phytosome

January 5, 2021 updated by: Azienda di Servizi alla Persona di Pavia

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

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pavia, Italy, 27100
        • Azienda di Servizi alla Persona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
Active Comparator: Combined Bergamot Phytosome and Artichoke leaf dry extract
600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Actual)

July 2, 2020

Study Completion (Actual)

July 16, 2020

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 0921/22052019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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