Artichoke and Bergamot Phytosome
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2020
CompletedFirst Submitted
Initial submission to the registry
December 29, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedJanuary 6, 2021
January 1, 2021
1.4 years
December 29, 2020
January 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of lipid parameters
Total cholesterol, LDL cholesterol, HDL cholesterol (mg/dl)
Baseline / 30 days / 60 days
Secondary Outcomes (9)
Changes of lipid parameters
Baseline / 30 days / 60 days
Changes of metabolic parameters
Baseline / 30 days / 60 days
Changes of metabolic parameters
Baseline / 30 days / 60 days
Changes of anthropometric measurements
Baseline / 30 days / 60 days
Changes of anthropometric measurements
Baseline / 30 days / 60 days
- +4 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORCombined Bergamot Phytosome and Artichoke leaf dry extract
ACTIVE COMPARATOR600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract
Interventions
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.
Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- liver, renal and thyroid diseases
- history of cardiovascular disease (CVD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda di Servizi alla Persona
Pavia, 27100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2020
First Posted
January 6, 2021
Study Start
February 21, 2019
Primary Completion
July 2, 2020
Study Completion
July 16, 2020
Last Updated
January 6, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share