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+)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARKOSTEROL.
- Who it may be relevant to
- Registry conditions: Cholesterolemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- 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).
Primary outcome measures
- Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated [Time frame: 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 [Time frame: four months]
Secondary outcome measures (5)
- change in triglycerides [Time frame: 2-4 months]
- change in VLDL [Time frame: 2-4 months]
- change in Apo A [Time frame: 2-4 months]
- change in Apo B [Time frame: 2-4 months]
- change in Liposcale [Time frame: 2-4 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 7 centers
- Centro de Salud Goya — Madrid
- Centro de Salud Daroca — Madrid
- Centro de Salud Avenida de Aragón — Madrid
- Centro de Salud Avenida de Aragón — Madrid
- Centro de Salud Casco Antiguo — Cartagena
- Centro de Salud Isaac Peral — Cartagena
- Centro de Salud de Mazarrón — Mazarrón
Identifiers
NCT: NCT07178769 · METACHOL+ · METACHOL+