Metachol+: bergamot and artichoke supplement to reduce cholesterol
Multicenter Randomized Open-label Controlled Clinical Study to Evaluate the Efficacy and Safety of a Nutritional Supplement Based on Bergamot, Artichoke and Other Ingredients After Four Months of Treatment in Reducing Cholesterol Levels in Patients With Moderate or Mild Hypercholesterolemia
NA · Laboratoires Arkopharma · NCT07178769
This trial tests whether the Metachol+ bergamot-and-artichoke supplement can lower LDL cholesterol in adults with mild-to-moderate high cholesterol.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 207 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laboratoires Arkopharma (industry) |
| Locations | 7 sites (Madrid, Madrid and 6 other locations) |
| Trial ID | NCT07178769 on ClinicalTrials.gov |
What this trial studies
Adults with LDL above 130 mg/dL and mild-to-moderate cardiovascular risk are assigned to one of three groups for four months: one capsule nightly, two capsules nightly, or continuing healthy lifestyle habits. The primary outcome is change in LDL cholesterol after four months, with secondary outcomes including full lipid profile, anthropometric measures, vital signs, treatment adherence, safety, and patient satisfaction. Key exclusions include recent use of other lipid-lowering drugs or supplements, decompensated medical conditions, pregnancy or breastfeeding, and allergy to product components. The supplement is supplied by Laboratoires Arkopharma and the trial is run at primary care centers in Madrid.
Who should consider this trial
Good fit: Adults aged 18 or older with mild-to-moderate cardiovascular risk and LDL cholesterol above 130 mg/dL who can attend visits at Madrid health centers and avoid other lipid-lowering products are the ideal candidates.
Not a fit: People with severe or decompensated cardiovascular disease, those already taking lipid-lowering medications or supplements, pregnant or breastfeeding individuals, or those allergic to the product ingredients are unlikely to benefit.
Why it matters
Potential benefit: If effective, the supplement could provide a non-prescription option to modestly lower LDL cholesterol and improve lipid profiles for some patients.
How similar studies have performed: Some small clinical studies of bergamot-containing supplements have reported modest LDL reductions, but overall evidence is limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are willing and able to understand and sign the informed consent after the nature of the study has been fully explained to them and they have passed the inclusion/exclusion criteria. 2. Patients aged greater than or equal to 18 years 3. Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl. Exclusion Criteria: 1. Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection. 2. Allergy or hypersensitivity to any of the components of the study treatment. 3. Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN. 4. Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study. 5. HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia. 6. Liver, kidney or muscle disorders. 7. Psychiatric disorders or inability to sign the consent. 8. Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.
Where this trial is running
Madrid, Madrid and 6 other locations
- Centro de Salud Goya — Madrid, Madrid, Spain (NOT_YET_RECRUITING)
- Centro de Salud Daroca — Madrid, Madrid, Spain (RECRUITING)
- Centro de Salud Avenida de Aragón — Madrid, Madrid, Spain (NOT_YET_RECRUITING)
- Centro de Salud Avenida de Aragón — Madrid, Madrid, Spain (NOT_YET_RECRUITING)
- Centro de Salud Casco Antiguo — Cartagena, Murcia, Spain (RECRUITING)
- Centro de Salud Isaac Peral — Cartagena, Murcia, Spain (RECRUITING)
- Centro de Salud de Mazarrón — Mazarrón, Murcia, Spain (RECRUITING)
Study contacts
- Study coordinator: Lucía San Miguel Amelivia, Pharmacist
- Email: Lucia.SanMiguel@arkopharma.com
- Phone: +34 616960711
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: Cholesterolemia