Evaluating a nutraceutical for improving cholesterol levels
Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol
NA · University of Pavia · NCT06340308
This study is testing a new supplement to see if it can lower LDL cholesterol levels in people who have high cholesterol but aren't taking any cholesterol-lowering medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pavia (other) |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06340308 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek, and SelectSIEVE® OptiChol on the lipid profile of patients with elevated LDL cholesterol levels. Participants will be randomly assigned to receive either the nutraceutical or a placebo for a duration of 12 weeks. The primary focus is to determine if this combination can effectively lower LDL cholesterol levels in individuals who are not currently on lipid-lowering medications.
Who should consider this trial
Good fit: Ideal candidates are individuals with LDL cholesterol levels between 115 and 190 mg/dl who are seeking primary prevention of cardiovascular diseases.
Not a fit: Patients with neoplastic and liver diseases, renal failure, diabetes mellitus, or those currently taking lipid-lowering medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a natural alternative for managing cholesterol levels in patients with dyslipidemias.
How similar studies have performed: While there is limited data on this specific combination, similar nutraceutical approaches have shown promise in managing cholesterol levels in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pavia
- IRCCS Policlinico S. Matteo Foundation — Pavia, Italy (RECRUITING)
Study contacts
- Study coordinator: Giuseppe Derosa
- Email: giuseppe.derosa@unipv.it
- Phone: +390382502614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyslipidemias