Cholesterolemia
Conditions
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 (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
Interventions
DIETARY_SUPPLEMENTARKOSTEROL
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).
Sponsors
Laboratoires Arkopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated | four months | 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. |
| 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 | four months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Apo A | 2-4 months | 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. |
| change in triglycerides | 2-4 months | 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. |
| change in Liposcale | 2-4 months | 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 |
| change in Apo B | 2-4 months | 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 |
| change in VLDL | 2-4 months | 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 |
Countries
Spain
Contacts
Primary ContactLucía San Miguel Amelivia, Pharmacist
Backup ContactMª Victoria Lara García-Brioles, Pharmacist
Outcome results
None listed