Artichoke and Bergamot Phytosome

NCT ID: NCT04697121

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2020-07-16

Brief Summary

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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).

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.

Combined Bergamot Phytosome and Artichoke leaf dry extract

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

Group Type ACTIVE_COMPARATOR

Combined Bergamot phytosome and Artichoke leaf dry extract

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda di Servizi alla Persona

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0921/22052019

Identifier Type: -

Identifier Source: org_study_id

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