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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 12
- 主要终点
- Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated
研究概览
简要总结
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:
- 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.
- 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.
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
排除标准
- •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.
结局指标
主要结局
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated
时间窗: four months
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients treated with a nutritional supplement (regardless of its dose) and patients in the control group. Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group.
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
时间窗: four months
Difference in the change in LDL cholesterol after four months of treatment compared to the baseline visit between patients in group 1, group 2 and patients in the control group
次要结局
- change in triglycerides(2-4 months)
- change in VLDL(2-4 months)
- change in Apo A(2-4 months)
- change in Apo B(2-4 months)
- change in Liposcale(2-4 months)