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| ID | Type | Description | Link |
|---|---|---|---|
| METACHOL+ | Other Identifier | Effice spi S.L. |
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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
There are three treatment arms:
It is expected to recruit 207 patients in total, 69 in each group/arm
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Gr 1) | Experimental | 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. |
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| Arm 2 (Gr 2) | Experimental | 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. |
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| Arm 3 (Control): Patients not taking METACHOL+ | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARKOSTEROL | Dietary Supplement | After 2 and 4 months from the start of treatment, a follow-up will be carried out in which anthropometric data will be measured (weight, BMI, waist circumference), vital signs (blood pressure and pulse) and a sample will be taken for analysis to measure the following parameters: CT, LDL, HDL, triglycerides, VLDL, Apo A, Apo B, liver function (GOT, GPT) and kidney function (creatinine) and Liposcale ® (in case of treatment group). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated | Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated with a nutritional supplement (regardless of its dose) and patients in the control group. Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group. | four months |
| Difference in the change in LDL cholesterol after fou months of treatment compared to the baseline visit between patients treated in 1, 2 and control group | Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group | four months |
| Measure | Description | Time Frame |
|---|---|---|
| change in triglycerides | Difference in the change in triglycerides after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2. | 2-4 months |
| change in VLDL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucía San Miguel Amelivia, Pharmacist | Contact | +34 616960711 | Lucia.SanMiguel@arkopharma.com | |
| Mª Victoria Lara García-Brioles, Pharmacist | Contact | +34 686449374 | maria-victoria.lara@arkopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Guyoux Aurelie | Arkopharma Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Goya | Not yet recruiting | Madrid | Madrid | 28009 | Spain |
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Difference in the change in VLDL after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2
| 2-4 months |
| change in Apo A | Difference in the change in Apo A after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2. | 2-4 months |
| change in Apo B | Difference in the change in Apo B after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2 | 2-4 months |
| change in Liposcale | Difference in the change in Liposcale after 2 and 4 months of treatment compared to the baseline visit between patients in group 1 and patients in group 2 | 2-4 months |
| Centro de Salud Daroca | Recruiting | Madrid | Madrid | 28017 | Spain |
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| Centro de Salud Avenida de Aragón | Not yet recruiting | Madrid | Madrid | 28027 | Spain |
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| Centro de Salud Avenida de Aragón | Not yet recruiting | Madrid | Madrid | 28027 | Spain |
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| Centro de Salud Casco Antiguo | Recruiting | Cartagena | Murcia | 30201 | Spain |
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| Centro de Salud Isaac Peral | Recruiting | Cartagena | Murcia | 30300 | Spain |
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| Centro de Salud de Mazarrón | Recruiting | Mazarrón | Murcia | 30870 | Spain |
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