Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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