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+) (METACHOL+)

Arkopharma

Status: Enrolling

Conditions: Cholesterolemia

Treatments: Dietary Supplement: ARKOSTEROL

Study type: Interventional

Funder types: Industry

Identifiers

NCT07178769

METACHOL+ (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 207 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 in the study or others that may interfere with the study.
5. HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.
6. Liver, kidney or muscle disorders.
7. Psychiatric disorders or inability to sign the consent.
8. Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 3 patient groups

Arm 1 (Gr 1)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: ARKOSTEROL

Arm 2 (Gr 2)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: ARKOSTEROL

Arm 3 (Control): Patients not taking METACHOL+

No Intervention group

Description:

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.