Berberol P for Mild-to-Moderate Hypercholesterolaemia
A Randomized, Controlled, Multicentre, Three-Arm Clinical Trial to Evaluate the Efficacy and Safety of Berberol® P Compared With Berberol® K in Adults With Mild-to-Moderate Hypercholesterolaemia
1 other identifier
interventional
255
1 country
4
Brief Summary
This randomized, controlled, multicentre clinical trial will evaluate the efficacy and safety of Berberol® P compared with Berberol® K in adults with mild-to-moderate hypercholesterolaemia. A total of 255 participants will be randomized in a 1:1:1 ratio to receive Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily for 12 weeks. The study will primarily assess whether Berberol® P is non-inferior to Berberol® K in reducing low-density lipoprotein cholesterol (LDL-C). Changes in other lipid parameters, glucose metabolism, anthropometric measures, blood pressure, and safety will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2026
CompletedFirst Posted
Study publicly available on registry
August 27, 2026
CompletedStudy Start
First participant enrolled
September 7, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
Study Completion
Last participant's last visit for all outcomes
July 30, 2027
August 27, 2026
August 1, 2026
11 months
August 22, 2026
August 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline
Change in serum LDL-C concentration from baseline to the end of treatment. The primary analysis will assess the non-inferiority of Berberol® P compared with Berberol® K in reducing LDL-C.
Baseline to Week 12
Secondary Outcomes (27)
Change in Total Cholesterol From Baseline
Baseline to Week 12
Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline
Baseline to Week 12
Change in Triglycerides From Baseline
Baseline to Week 12
Change in Fasting Blood Glucose From Baseline
Baseline to Week 12
Change in Glycated Hemoglobin (HbA1c) From Baseline
Baseline to Week 12
- +22 more secondary outcomes
Study Arms (3)
Berberol® P - 1 Tablet Daily
EXPERIMENTALParticipants will receive Berberol® P 1 tablet once daily after dinner for 12 weeks.
Berberol P® - 2 Tablets Daily
EXPERIMENTALParticipants will receive Berberol® P 2 tablets daily, with 1 tablet after breakfast and 1 tablet after dinner, for 12 weeks.
Berberol K® - 1 Tablet Daily
ACTIVE COMPARATORParticipants will receive Berberol® K 1 tablet once daily after dinner for 12 weeks.
Interventions
Dietary supplement containing Berberine Phytosome® and Pycrinil®. Participants receive either 1 tablet daily after dinner or 2 tablets daily (1 after breakfast and 1 after dinner) for 12 weeks, according to the assigned treatment arm.
Dietary supplement containing Berberine Phytosome® and monacolins from fermented red yeast rice. Participants receive 1 tablet daily after dinner for 12 weeks.
Eligibility Criteria
You may qualify if:
- Age 18-70 years
- Male or female
- LDL-C 115-190 mg/dL and/or total cholesterol 200-260 mg/dL
- Triglycerides \<400 mg/dL
- Willingness to maintain stable diet and physical activity
- Written informed consent for study participation obtained prior to the start of the study
You may not qualify if:
- Use of statins, ezetimibe, fibrates, PCSK9 inhibitors, or lipid-lowering nutraceuticals within 30 days prior to enrollment
- Uncontrolled diabetes
- Significant liver or kidney disease
- Pregnancy or breastfeeding
- Known intolerance to any component of the study products
- Recent cardiovascular events
- Alcohol or drug abuse
- Participation in another clinical trial within 30 days prior to enrollment
- Lack of written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Poliambulatorio Health
Piacenza, Emilia-Romagna, 29122, Italy
Euromed
Guidonia Montecelio, Lazio, 00012, Italy
Endomed
Rome, Lazio, 00152, Italy
University of Urbino Carlo Bo
Urbino, The Marches, 61029, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Biochemistry and Experimental Medicine
Study Record Dates
First Submitted
August 22, 2026
First Posted
August 27, 2026
Study Start (Estimated)
September 7, 2026
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 2027
Last Updated
August 27, 2026
Record last verified: 2026-08