NCT07178769Recruiting
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+)
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (LDL) values after four months of treatment compared to maintaining healthy lifestyle habits. The secondary objectives are * Evaluate the improvement of the lipid profile compared to maintaining healthy lifestyle habits. * Evaluate the difference in effect between 1 tablet and 2 tablets daily in improving the lipid profile. * Evaluate changes in anthropometric data and vital signs. * Evaluate adherence to treatment * Evaluate the safety profile of the product * Evaluate satisfaction with treatment There are three treatment arms: 1. Arm 1 (Gr 1): Patients being treated with a nutritional supplement based on bergamot, artichoke and other ingredients with one capsule every night at dinner with a glass of water for four months. 2. Arm 2 (Gr 2): Patients treated with a nutritional supplement based on bergamot, artichoke and other ingredients with two capsules every night at dinner with a glass of water for four months. 3. Arm 3 (Control): Patients not taking METACHOL+. All patients in the study will be recommended to lead an active life and a healthy diet, providing them with instructions to follow according to their usual clinical practice. It is expected to recruit 207 patients in total, 69 in each group/arm
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 207 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- 20 Apr 2025
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Laboratoires Arkopharma
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07178769
What you commit to
- Study type: Interventional
- Planned participants: 207
- From 20 Apr 2025 to the primary completion date, 30 Jul 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Salud Casco Antiguo Coordinator of this site? Confirm its status | Cartagena | Spain | Recruiting |
| Centro de Salud Isaac Peral Coordinator of this site? Confirm its status | Cartagena | Spain | Recruiting |
| Centro de Salud Daroca Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Centro de Salud Avenida de Aragón Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Centro de Salud Goya Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Centro de Salud de Mazarrón Coordinator of this site? Confirm its status | Mazarrón | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.