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NCT06340308 Clinical Trial

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

Dyslipidemias Clinical Trial

— PARAF  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06340308
Other study ID # PARAF 986117570
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date May 2024

Study information
Verified date March 2024
Source University of Pavia
Contact Giuseppe Derosa
Phone +390382502614
Email giuseppe.derosa@unipv.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date May 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 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
• 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

Locations
Country Name City State
Italy IRCCS Policlinico S. Matteo Foundation Pavia

Sponsors (2)
Lead Sponsor Collaborator
University of Pavia Foundation IRCCS San Matteo Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variations of lipid profile 12 weeks
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