Study To Evaluate The Efficacy And Safety Of A Nutritional Supplement Based On Bergamot, A
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
| Condition(s) | Cholesterolemia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 (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 supplemen |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Laboratoires Arkopharma |
| Locations | Madrid, Madrid, Spain; Madrid, Madrid, Spain; Madrid, Madrid, Spain; Madrid, Madrid, Spain; Cartagena, Murcia, Spain; Cartagena, Murcia, Spain (+1 more sites) |
| Start date | 2025-04-20 |
| NCT ID | NCT07178769 |
| Official listing | https://clinicaltrials.gov/study/NCT07178769 |