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+)

Condition(s) studied

Investigational drug(s) / intervention(s)

ARKOSTEROL: 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).

Study 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

Eligibility

Primary outcome measure(s)

• 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

Trial sites (7)