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+)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratoires Arkopharma

About this trial

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 criteria

Qualifiers

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/

Disqualifiers

Patients aged greater than or equal to 18 years

Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl.

Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.

Allergy or hypersensitivity to any of the components of the study treatment.

Trial design

Treatments tested in this trial

  • ARKOSTEROL

Treatment groups

207 Participants
are divided into 3 treatment groups

Sponsors and collaborators