Status:
RECRUITING
Study To Evaluate The Efficacy And Safety Of A Nutritional Supplement Based On Bergamot, Artichoke And Other Ingredients For Reducing Cholesterol Levels In Patients With Hypercholesterolemia (Metachol+)
Lead Sponsor:
Laboratoires Arkopharma
Conditions:
Cholesterolemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial with food supplement is to evaluate the effectiveness of a nutritional supplement based on bergamot, artichoke and other ingredients through low-density lipoprotein (LD...
Eligibility Criteria
Inclusion
- 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.
- Patients aged greater than or equal to 18 years
- Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl.
Exclusion
- Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.
- Allergy or hypersensitivity to any of the components of the study treatment.
- Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN.
- Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study.
- HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.
- Liver, kidney or muscle disorders.
- Psychiatric disorders or inability to sign the consent.
- Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT07178769
Start Date
April 20 2025
End Date
July 30 2026
Last Update
September 17 2025
Active Locations (7)
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1
Centro de Salud Goya
Madrid, Madrid, Spain, 28009
2
Centro de Salud Daroca
Madrid, Madrid, Spain, 28017
3
Centro de Salud Avenida de Aragón
Madrid, Madrid, Spain, 28027
4
Centro de Salud Avenida de Aragón
Madrid, Madrid, Spain, 28027