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+)
NCT ID: NCT07178769
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
207 participants
INTERVENTIONAL
2025-04-20
2026-07-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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).
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.
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).
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.
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Exclusion Criteria
3. Patients with moderate or mild cardiovascular risk, who have LDL levels greater than 130 mg/dl.
1. Use of any other drug or food supplement for the treatment of hypercholesterolemia during the 30 days prior to selection.
2. Allergy or hypersensitivity to any of the components of the study treatment.
3. Decompensated cardiovascular disease, decompensated diabetes mellitus, decompensated HTN.
4. Serious medical conditions such as: cancer, serious chronic illness considered incompatible with participation in the study or others that may interfere with the study.
5. HIV-AIDS, Pregnancy or breastfeeding, occlusion of the central retinal artery (of foreseeable vascular origin), history of cardiovascular disease and familial hypercholesterolemia.
6. Liver, kidney or muscle disorders.
7. Psychiatric disorders or inability to sign the consent.
8. Subjects with extreme eating habits and/or with a significant history of anorexia nervosa, bulimia and other eating disorders.
18 Years
ALL
No
Sponsors
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Laboratoires Arkopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Guyoux Aurelie
Role: STUDY_DIRECTOR
Arkopharma Laboratories
Locations
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Centro de Salud Goya
Madrid, Madrid, Spain
Centro de Salud Daroca
Madrid, Madrid, Spain
Centro de Salud Avenida de Aragón
Madrid, Madrid, Spain
Centro de Salud Avenida de Aragón
Madrid, Madrid, Spain
Centro de Salud Casco Antiguo
Cartagena, Murcia, Spain
Centro de Salud Isaac Peral
Cartagena, Murcia, Spain
Centro de Salud de Mazarrón
Mazarrón, Murcia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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METACHOL+
Identifier Type: OTHER
Identifier Source: secondary_id
METACHOL+
Identifier Type: -
Identifier Source: org_study_id
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