Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change of inflammatory status in the participants
研究概览
简要总结
The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.
详细描述
Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. Recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. However, there are no studies in dyslipidemic patients evaluating these data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Both sexes;
- •Over 18 years of age;
- •Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL);
- •Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
- •increased LDL-c (LDL-c ≥ 160 mg/dL)
- •TG (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
- •Reduction in HDL-c (men < 40 mg/dL and women < 50 mg/dL) alone or in association with an increase in LDL-c or TG. If TG ≥ 400 mg/dL.
- •Individuals who are already using lipid-lowering therapy (statins or non-statins) will also be included.
排除标准
- •Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;
- •Pregnant women;
- •Participants using catabolic drugs or antibiotics
- •Participants on anticoagulant medication
- •Participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch.
研究组 & 干预措施
Nattokinase group
Participants will receive 1 capsule per day, providing the active nattokinase daily, at a dosage of 100mg, standardized at 2,000 Fibrinolytic Units.
干预措施: Nattokinase (Dietary Supplement)
Placebo Group
The placebo group will receive the same amount of 100mg placebo, at the same time, containing corn starch.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change of inflammatory status in the participants
时间窗: Baseline and 8 weeks
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers: interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP).
次要结局
- Change in plasma fibrinogen levels, lipid peroxidation and improvement in lipid profile.(Baseline and 8 weeks)