NCT04574505已完成不适用
Evaluation of the Effect of a Food Supplementation With Eufortyn Colesterolo Plus on the Modulation of LDL Cholesterolemia in Subjects Affected by Polygenic Hypercholesterolemia: a Two-arm Double-blind, Placebo- Controlled, Randomized, Clinical Trial.
University of Bologna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).
研究概览
简要总结
This is a two-arm randomized, placebo-controlled, double-blind, monocentric parallel-groups clinical study conducted in Italy.
The objective of this study is to evaluate the effect of dietary supplementation of a combined supplement containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara cardunculus) and Cynara scolimus, associated with high coenzyme Q10 bioavailability (Q10 phytosome® Ubiqsome) and zinc, on the glycometabolic structure of subjects with suboptimal levels of LDL cholesterolemia compared with placebo.
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
- Triple (Participant, Care Provider, 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
- 否
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 2019, 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 one component of the tested nutraceuticals
- •Women in fertile age not using consolidated contraceptive methods
- •Pregnancy and Breastfeeding.
结局指标
主要结局
The primary objective is to compare the effect on LDL-cholesterol after 8 weeks of treatment with a combined food supplement with placebo (standard diet only).
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Arrigo F.G. Cicero
Professor
University of Bologna
研究点 (1)
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