Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

NCT ID: NCT06340308

Last Updated: 2024-04-01

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol compared to placebo on lipid profile in patients with LDL cholesterol \> 115 and \< 190 mg/dl.Patients were allocated to receive 1 or 2 tablets of the nutraceutical for 12 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 tablet

Group Type EXPERIMENTAL

Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

Intervention Type DIETARY_SUPPLEMENT

Patients will take 1 tablet of Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol for 12 weeks

2 tablets

Group Type ACTIVE_COMPARATOR

Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

Intervention Type DIETARY_SUPPLEMENT

Patients will take 2 tablets of Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

Patients will take 1 tablet of Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

Patients will take 2 tablets of Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* LDL Cholesterol \> 115 mg/dl and \< 190 mg/dl
* primary prevention

Exclusion Criteria

* patients with neoplastic and liver diseases, renal failure and diabetes mellitus
* pregnant or breastfeeding women
* hypersensitivity to any of the ingredients
* therapy with lipid-lowering drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

University of Pavia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giuseppe Derosa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Policlinico S. Matteo Foundation

Pavia, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Giuseppe Derosa

Role: CONTACT

+390382502614

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Giuseppe Derosa, MD, PhD

Role: primary

Pamela Maffioli, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PARAF 986117570

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.