Multicenter Randomized Open-label Controlled Clinical Study to Evaluate the Efficacy and Safety of a Nutritional Supplement Based on Bergamot, Artichoke and Other Ingredients After Four Months of Treatment in Reducing Cholesterol Levels in Patients With Moderate or Mild Hypercholesterolemia

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
Spain
Centro de Salud Casco Antiguo
RECRUITING
Cartagena
Centro de Salud Isaac Peral
RECRUITING
Cartagena
Centro de Salud Avenida de Aragón
NOT_YET_RECRUITING
Madrid
Centro de Salud Avenida de Aragón
NOT_YET_RECRUITING
Madrid
Centro de Salud Daroca
RECRUITING
Madrid
Centro de Salud Goya
NOT_YET_RECRUITING
Madrid
Centro de Salud de Mazarrón
RECRUITING
Mazarrón
Contact Information
Primary
Lucía San Miguel Amelivia, Pharmacist
Lucia.SanMiguel@arkopharma.com
+34 616960711
Backup
Mª Victoria Lara García-Brioles, Pharmacist
maria-victoria.lara@arkopharma.com
+34 686449374
Time Frame
Start Date: 2025-04-20
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 207
Treatments
Experimental: 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.
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Laboratoires Arkopharma

This content was sourced from clinicaltrials.gov