NCT07178769

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+)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: Laboratoires Arkopharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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).

Timeline

• Start date: 2025-04-20
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2025-09-17
• Last updated: 2025-09-17

Locations

7 sites across 1 country: Spain