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+)

NCT07178769 | Recruiting DMC

• 1 other identifier: METACHOL+
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 7

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:
• 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.
• 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.
• 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.

Conditions

Cholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• change in triglycerides

  2-4 months

• change in VLDL

  2-4 months

• change in Apo A

  2-4 months

• change in Apo B

  2-4 months

• change in Liposcale

  2-4 months

Study Arms (3)

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.

Dietary Supplement: ARKOSTEROL

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.

Dietary Supplement: ARKOSTEROL

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.

Interventions

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).

Arm 1 (Gr 1); Arm 2 (Gr 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN.
• Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study.
• HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.
• Liver, kidney or muscle disorders.
• Psychiatric disorders or inability to sign the consent.
• Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.

Sponsors & Collaborators

• Laboratoires Arkopharma: lead

Study Sites (7)

Centro de Salud Goya

Madrid, Madrid, 28009, Spain

NOT YET RECRUITING

Centro de Salud Daroca

Madrid, Madrid, 28017, Spain

RECRUITING

Centro de Salud Avenida de Aragón

Madrid, Madrid, 28027, Spain

NOT YET RECRUITING

Centro de Salud Avenida de Aragón

Madrid, Madrid, 28027, Spain

NOT YET RECRUITING

Centro de Salud Casco Antiguo

Cartagena, Murcia, 30201, Spain

RECRUITING

Centro de Salud Isaac Peral

Cartagena, Murcia, 30300, Spain

RECRUITING

Centro de Salud de Mazarrón

Mazarrón, Murcia, 30870, Spain

RECRUITING

Study Officials

• Guyoux Aurelie

  Arkopharma Laboratories

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)