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+)

Официальное название

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

Обзор

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

Вмешательства

• Пищевая добавка 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).

Первичные конечные точки

• Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated [Срок оценки: 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 [Срок оценки: four months]

Вторичные конечные точки (5)

• change in triglycerides [Срок оценки: 2-4 months]
• change in VLDL [Срок оценки: 2-4 months]
• change in Apo A [Срок оценки: 2-4 months]
• change in Apo B [Срок оценки: 2-4 months]
• change in Liposcale [Срок оценки: 2-4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 7 центров

• 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

Идентификаторы

NCT: NCT07178769 · METACHOL+ · METACHOL+

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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