Condition: Cholesterolemia · Sponsor: Laboratoires Arkopharma
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
This description comes directly from the study's public registry record.
Lucía San Miguel Amelivia, Pharmacist · +34 616960711 · Lucia.SanMiguel@arkopharma.com
Mª Victoria Lara García-Brioles, Pharmacist · +34 686449374 · maria-victoria.lara@arkopharma.com
Always discuss trial participation with your own doctor first.
| 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 |
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