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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06340308
Acronym
PARAF
Enrollment
36
Registered
2024-04-01
Start date
2023-06-07
Completion date
2024-05-31
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Brief summary

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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTBerberine-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

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Variations of lipid profile12 weeks

Countries

Italy

Contacts

Primary ContactGiuseppe Derosa
giuseppe.derosa@unipv.it+390382502614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026