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Artichoke and Bergamot Phytosome

NCT04697121 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-06

No results posted yet for this study

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

COMBINATION_PRODUCT

Placebo

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

Sponsors & Collaborators

  • Azienda di Servizi alla Persona di Pavia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2020-07-02
Completion
2020-07-16

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04697121 on ClinicalTrials.gov