NCT06403748尚未招募不适用
Evaluation of the Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels: a Two-arm Double-blind, Placebo-controlled, Randomized, Clinical Trial
University of Bologna2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Effect of the dietary supplement on LDL-C at 6-week follow-up
研究概览
简要总结
The primary purpose of our research will be to evaluate if, in subjects with a low-moderate cardiovascular risk (CV risk>1% but < 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol >115 mg/dL, < 190 mg/dL) supplementation with a food supplement is able to significantly influence plasma lipid levels. Furthermore, the systemic activation status of the inflammatory cascade and the arterial wall stiffness will be investigated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The subjects will have to meet all the following inclusion criteria:
- •Subjects agree to participate in the study and having dated and signed the informed consent form.
- •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.
- •Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements.
排除标准
- •Subjects fulfilling one or more of the following exclusion criteria will not be included in the study:
- •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 for at least 3 months;
- •Anticoagulant 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 participant 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 diseases 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 or to one of these plant species: Asteraceae or Compositae;
- •Women in fertile age not using consolidated contraceptive methods
- •Pregnancy and Breastfeeding.
结局指标
主要结局
Effect of the dietary supplement on LDL-C at 6-week follow-up
时间窗: 12 weeks
The primary objective is to compare the effect on LDL-C after 12 weeks of treatment with a combined food supplement compared to placebo (standard diet only).
次要结局
- Effect of the dietary supplement on lipid fractions(12 weeks)
- Effect of the dietary supplement on indexes of NAFLD(12 weeks)
- Effect of the dietary supplement on weight(12 weeks)
- Effect of the dietary supplement on blood pressure(12 weeks)
- Effect of the dietary supplement on eGFR(12 weeks)
- Effect of the dietary supplement on waist circumference(12 weeks)
- Tolerability of the dietary supplement(12 weeks)
- Effect of the dietary supplement on creatininemia(12 weeks)
- Effect of the dietary supplement on apolipoproteins(12 weeks)
- Effect of the dietary supplement on hsCRP(12 weeks)
- Effect of the dietary supplement on CPK levels(12 weeks)
- Acceptability of the dietary supplement(12 weeks)
研究者
Claudio Borghi
Prof. Dr.
University of Bologna
研究点 (2)
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