Evaluation of the Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Moderately Hypercholesterolemic Subjects: a Double-blind, Placebo-controlled, Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- LDL-cholesterolemia % reduction from baseline and between groups
研究概览
简要总结
The joint ESC/EAS guidelines for the management of dyslipidaemias recommend, for patients at low/moderate CV risk with raised LDL-C, a set of measures collectively defined as "lifestyle interventions", with use of drugs only if the LDL-C levels cannot be controlled with such lifestyle interventions. "Lifestyle interventions" also includes food supplements. The reason is the following: a simple "dietary advice" has been shown (Cochrane review and meta-analysis, Rees et al, 2013) to achieve a modest reduction of total-C and LDL-C. The review reports: Dietary advice reduced total serum cholesterol by 0.15 mmol/L (95% CI 0.06 to 0.23) and LDL cholesterol by 0.16 mmol/L (95% CI 0.08 to 0.24) after 3 to 24 months." An average reduction of LDL-C by 0.16 mmol/L (6.2 mg/dL) is definitely insufficient to control the level of LDL-C in those subjects. Therefore, those subjects would lose motivation to keep dieting. In this context, use of supplements would significantly amplify the result of diet.
A significant proportion of ischemic cardiovascular events are believed to be supported by the coexistence of traditional cardiovascular risk factors such as diabetes, hypertension, dyslipidemia, smoking, and others. The aggregation of these factors is accompanied by a significant increase in the risk of cardiovascular events.
Observational studies shown the existence of a relationship between cholesterolemia and coronary heart disease, clearly showing that subjects with even modestly increased total cholesterol values over time develop both fatal and non-fatal vascular events with a higher frequency compared to subjects with similar characteristics, but with lower basal values of cholesterol.
Numerous controlled intervention studies, on the other hand, have shown that there is a close correlation between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma concentration of total and LDL-C, obtained through lifestyle modification or specific drugs, result in reductions in the incidence of major coronary events. The effectiveness of these interventions has been demonstrated both in subjects in primary prevention and in patients in secondary prevention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects agree to participate in the study and having dated and signed the informed consent form.
- •Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
- •Male or female aged ≥ 18 years and ≤ 70 years old.
- •LDL-Cholesterol plasma levels >115 mg/dL and < 190 mg/dL.
- •TG<400 mg/dL.
- •Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to ESC/EAS guidelines 2012, the intervention strategy does not require a pharmacological lipid-lowering intervention.
排除标准
- •Subjects already affected by cardiovascular diseases (secondary prevention) or with estimated 10 years cardiovascular disease risk> 5%;
- •Obesity (BMI>30 kg/m2) or diabetes mellitus;
- •Assumption of lipid lowering drugs or food supplements, or drugs potentially affecting the lipid metabolism;
- •Antihypertensive treatment not stabilized since at least 3 months;
- •Anticoagulants therapy
- •Uncontrolled hypertension (systolic blood pressure> 190 mmHg or diastolic arterial pressure> 100 mmHg);
- •Known current thyroid, gastrointestinal or hepatobiliary diseases;
- •Any medical or surgical condition that would limit the patient adhesion to the study protocol;
- •Abuse of alcohol or drugs (current or previous);
- •History of malignant neoplasia in the 5 years prior to enrolment in the study;
- •History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
- •History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- •Known previous intolerance to the tested nutraceutical
- •Women in fertile age not using consolidated contraceptive methods
- •Pregnancy and Breastfeeding.
结局指标
主要结局
LDL-cholesterolemia % reduction from baseline and between groups
时间窗: 12 weeks
% reduction of LDL-cholesterolemia after 12 weeks of treatment
LDL-cholesterolemia absolute reduction from baseline and between groups
时间窗: 12 weeks
Absolute reduction of LDL-cholesterolemia after 12 weeks of treatment
次要结局
- Absolute reduction from baseline and between groups in anthropometric parameters(12 weeks)
- % reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios(12 weeks)
- % reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels(12 weeks)
- % reduction from baseline and between groups in anthropometric parameters(12 weeks)
- Absolute reduction from baseline and between groups in blood pressure levels(12 weeks)
- Absolute reduction from baseline and between groups in liver parameters(12 weeks)
- % reduction from baseline and between groups in liver parameters(12 weeks)
- Absolute reduction from baseline and between groups in other lipid fractions, apolipoproteins and their ratios(12 weeks)
- Absolute reduction from baseline and between groups in creatine phosphokinase (CPK) serum levels(12 weeks)
- % reduction from baseline and between groups in blood pressure levels(12 weeks)
研究者
Claudio Borghi
Professor
University of Bologna