- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697121
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
Status
Completed
Conditions
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
Keywords
Additional Relevant MeSH Terms
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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