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Artichoke and Bergamot Phytosome

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Combined Bergamot phytosome and Artichoke leaf dry extract
Placebo
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring bergamot, Cynara cardunculus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Azienda di Servizi alla Persona

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Combined Bergamot Phytosome and Artichoke leaf dry extract

Arm Description

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

Outcomes

Primary Outcome Measures

Changes of lipid parameters
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2020
Last Updated
January 5, 2021
Sponsor
Azienda di Servizi alla Persona di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04697121
Brief Title
Artichoke and Bergamot Phytosome
Official Title
Artichoke and Bergamot Phytosome: a Randomized Double Blind Clinical Trial in Bergamot Poor-responders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
bergamot, Cynara cardunculus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Combined Bergamot Phytosome and Artichoke leaf dry extract
Arm Type
Active Comparator
Arm Description
600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Combined Bergamot phytosome and Artichoke leaf dry extract
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
Primary Outcome Measure Information:
Title
Changes of lipid parameters
Description
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)
Time Frame
Baseline / 30 days / 60 days
Secondary Outcome Measure Information:
Title
Changes of lipid parameters
Description
apolipoprotein A, apolipoprotein B, triglycerides (mg/dl)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of metabolic parameters
Description
Fasting blood glucose (mg/dl)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of metabolic parameters
Description
Glycated Hemoglobin (percent)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of anthropometric measurements
Description
Weight (kg) and height (m) were combined to report BMI in kg/m^2
Time Frame
Baseline / 30 days / 60 days
Title
Changes of anthropometric measurements
Description
waist circumference (cm)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of body composition
Description
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of safety parameters
Description
Aspartate Aminotransferase (UI/l), Alanine Aminotransferase (UI/l)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of safety parameters
Description
Gamma Glutamyl Transferase (U/l)
Time Frame
Baseline / 30 days / 60 days
Title
Changes of safety parameters
Description
Creatinine (mg/dl)
Time Frame
Baseline / 30 days / 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Azienda di Servizi alla Persona
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Artichoke and Bergamot Phytosome

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