Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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+)

Led by Laboratoires Arkopharma · Updated on 2025-09-17

207

Participants Needed

7

Research Sites

66 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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+)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients willing and able to understand and sign the informed consent
  • Patients aged 18 years or older
  • Patients with moderate or mild cardiovascular risk and LDL cholesterol levels greater than 130 mg/dl
Not Eligible

You will not qualify if you...

  • Use of any other drug or food supplement for hypercholesterolemia within 30 days before selection
  • Allergy or hypersensitivity to any component of the study treatment
  • Decompensated cardiovascular disease, diabetes, or hypertension
  • Serious medical conditions such as cancer or other chronic illnesses incompatible with study participation
  • HIV/AIDS, pregnancy, breastfeeding, central retinal artery occlusion, history of cardiovascular disease, or familial hypercholesterolemia
  • Liver, kidney, or muscle disorders
  • Psychiatric disorders or inability to sign consent
  • Extreme eating habits or history of eating disorders such as anorexia or bulimia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 7 locations

1

Centro de Salud Goya

Madrid, Madrid, Spain, 28009

Not Yet Recruiting

2

Centro de Salud Daroca

Madrid, Madrid, Spain, 28017

Actively Recruiting

3

Centro de Salud Avenida de Aragón

Madrid, Madrid, Spain, 28027

Not Yet Recruiting

4

Centro de Salud Avenida de Aragón

Madrid, Madrid, Spain, 28027

Not Yet Recruiting

5

Centro de Salud Casco Antiguo

Cartagena, Murcia, Spain, 30201

Actively Recruiting

6

Centro de Salud Isaac Peral

Cartagena, Murcia, Spain, 30300

Actively Recruiting

7

Centro de Salud de Mazarrón

Mazarrón, Murcia, Spain, 30870

Actively Recruiting

Loading map...

Research Team

L

Lucía San Miguel Amelivia, Pharmacist

CONTACT

M

Mª Victoria Lara García-Brioles, Pharmacist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here