Hypercholesterolemia
Conditions
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.
Detailed description
Hypercholesterolaemia is an important modifiable cardiovascular risk factor. Nutraceutical approaches may provide an option for individuals with mild-to-moderate hypercholesterolaemia, particularly when lifestyle measures alone are insufficient. This is a randomized, controlled, multicentre, three-arm clinical trial evaluating two daily doses of Berberol® P compared with Berberol® K. Eligible participants will be randomized in a 1:1:1 ratio to one of three treatment groups: Berberol® P 1 tablet daily, Berberol® P 2 tablets daily, or Berberol® K 1 tablet daily. Treatment will continue for 12 weeks. The primary objective is to evaluate the non-inferiority of Berberol® P compared with Berberol® K with respect to the change in LDL-C after 12 weeks of treatment. The study will also evaluate effects on the lipid profile, glucose metabolism, anthropometric parameters and blood pressure, as well as the safety and tolerability of the interventions. A total of 255 participants are planned to be enrolled across multiple study centres.
Interventions
DIETARY_SUPPLEMENTBerberol® P (manufacturer: PharmExtracta S.p.A.)
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_SUPPLEMENTBerberol® K (manufacturer: PharmExtracta S.p.A.)
Dietary supplement containing Berberine Phytosome® and monacolins from fermented red yeast rice. Participants receive 1 tablet daily after dinner for 12 weeks.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline | Baseline to Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose From Baseline | Baseline to Week 12 | Change in fasting blood glucose concentration (mg/dL) from baseline to the end of treatment. |
| Change in Glycated Hemoglobin (HbA1c) From Baseline | Baseline to Week 12 | Change in HbA1c (%) from baseline to the end of the 12-week treatment period. |
| Change in Fasting Insulin From Baseline | Baseline to Week 12 | Change in fasting serum insulin concentration from baseline to the end of the 12-week treatment period. |
| Change in Systolic Blood Pressure From Baseline | Baseline to Week 12 | Change in systolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period. |
| Change in Diastolic Blood Pressure From Baseline | Baseline to Week 12 | Change in diastolic blood pressure (mmHg) from baseline to the end of the 12-week treatment period. |
| Change in Heart Rate From Baseline | Baseline to Week 12 | Change in heart rate (beats per minute) from baseline to the end of the 12-week treatment period. |
| Incidence of Adverse Events | Baseline to Week 12 | Number and proportion of participants experiencing adverse events during the 12-week treatment period. |
| Change in Safety Laboratory Parameters From Baseline | Baseline to Week 12 | Change from baseline to Week 12 in safety laboratory parameters, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), C-reactive protein (CRP), and creatinine. |
| Change in Body Weight From Baseline | Baseline to Week 12 | Change in body weight (kg) from baseline to the end of the 12-week treatment period. |
| Change in Waist Circumference From Baseline | Baseline to Week 12 | Change in waist circumference (cm) from baseline to the end of the 12-week treatment period. |
| Change in Non-HDL Cholesterol From Baseline | Baseline to Week 12 | Change in calculated non-HDL cholesterol concentration from baseline to the end of the 12-week treatment period. |
| Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol From Baseline | Baseline to Week 12 | Change in calculated VLDL cholesterol concentration (mg/dL) from baseline to the end of the 12-week treatment period. |
| Change in Total Cholesterol to HDL Cholesterol Ratio (TC/HDL) From Baseline | Baseline to Week 12 | Change in calculated total cholesterol to HDL cholesterol ratio (TC/HDL) from baseline to the end of the 12-week treatment period. |
| Change in LDL Cholesterol to HDL Cholesterol Ratio (LDL/HDL) From Baseline | Baseline to Week 12 | Change in calculated LDL cholesterol to HDL cholesterol ratio (LDL/HDL) from baseline to the end of the 12-week treatment period. |
| Change in Triglyceride to HDL Cholesterol Ratio (TG/HDL) From Baseline | Baseline to Week 12 | Change in calculated triglyceride to HDL cholesterol ratio (TG/HDL) from baseline to the end of the 12-week treatment period. |
| Change in Remnant Cholesterol From Baseline | Baseline to Week 12 | Change in calculated remnant cholesterol concentration from baseline to the end of the 12-week treatment period. |
| Change in Apolipoprotein A1 (Apo A1) From Baseline | Baseline to Week 12 | Change in Apo A1 concentration from baseline to the end of the 12-week treatment period. |
| Change in Apolipoprotein B (ApoB) From Baseline | Baseline to Week 12 | Change in ApoB concentration (mg/dL) from baseline to the end of the 12-week treatment period. |
| Change in Apolipoprotein B to Apolipoprotein A1 Ratio (ApoB/Apo A1) From Baseline | Baseline to Week 12 | Change in the calculated ApoB/Apo A1 ratio from baseline to the end of the 12-week treatment period. |
| Severity of Undesirable Symptoms | Baseline to Week 12 | Severity of undesirable symptoms during treatment, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache, assessed by participants on a 0 to 10 scale, where 0 indicates "no problem" and 10 indicates "very severe problem," based on symptoms experienced during the previous 7 days. |
| Frequency of Undesirable Symptoms | Baseline to Week 12 | Frequency of undesirable symptoms, including myalgias, cramps, nausea, diarrhea, constipation, abdominal pain, asthenia, and headache. For each symptom present, participants will report its frequency as occasional, intermittent, or daily. |
| Participant-Reported Treatment Tolerability Score on a 0-10 Scale | Week 12 | Treatment tolerability will be assessed by participants at Week 12 using the protocol-defined 0-10 numerical rating scale and recorded in the case report form (CRF). |
| Participant-Reported Treatment Adherence Percentage | Week 12 | Treatment adherence will be assessed at Week 12 using the protocol-defined 0-100% adherence scale recorded in the CRF. |
| Treatment Adherence Based on Returned Unused Tablets | Week 12 | Treatment adherence will be assessed at Week 12 based on the number of unused study tablets returned by participants at the end of the treatment period. |
| Change in Total Cholesterol From Baseline | Baseline to Week 12 | Change in serum total cholesterol concentration from baseline to the end of the 12-week treatment period. |
| Change in Triglycerides From Baseline | Baseline to Week 12 | Change in serum triglyceride concentration from baseline to the end of the 12-week treatment period. |
| Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline | Baseline to Week 12 | Change in serum HDL-C concentration from baseline to the end of the 12-week treatment period. |
Countries
Italy
Contacts
CONTACTProf. Davide Sisti, PhD
Outcome results
None listed