Effects of the Natural Supplement CitraVes Containing Nanovesicles Delivered From Citrus Limon (L.) Juice on Cardio-metabolic Risk Factors in Subjects With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in Plasma Lipids in Healthy Subjects
研究概览
简要总结
Clinical trial about beneficial effects of natural supplement in a spray-dried formulation, citraVes™, obtained from Citrus Limon (L.) juice on general body health.
详细描述
This is one randomized, double-blind, placebo-controlled study. The aim of the present study is to investigate the role of a natural product, citraVes™ on several cardiovascular risk factors.
The research hypothesis is to evaluate whether this natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (Navhetec S.R.L., Palermo, Italy) may improve different cardio-metabolic parameters in subjects with the metabolic syndrome. All subjects will be evaluated at baseline, after 1 month and after 3 and 6 months of supplementation with natural product or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women > 18 years old;
- •body mass index (BMI) > 25 kg/m²;
- •subjects who are able to swallow;
- •subjects who are willing to participate in the study and therefore, to sign informed consent prior to any study procedure;
- •the inclusion criteria for patients with MetS was also the diagnosis of MetS, as defined by international consensus [Alberti KG, et al. Circulation. 2009; 120:1640-5].
排除标准
- •pregnancy or the willingness to become pregnant;
- •severe renal or hepatic impairment;
- •known severe infections (such as HIV, HBV, HCV)
- •any neoplasms;
- •the exclusion criteria for healthy volunteers were also diagnosis of any one of the following diseases: hypertension, diabetes mellitus, dyslipidaemia or metabolic diseases.
结局指标
主要结局
Change from Baseline in Plasma Lipids in Healthy Subjects
时间窗: 3 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C) (mmol/l).
Change from Baseline in Plasma Lipids in Subjects with Metabolic Syndrome
时间窗: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C) (mmol/l).
次要结局
- Change from Baseline in Glycemia in Subjects with Metabolic Syndrome(6 months)
- Change from Baseline in Waist Circumference in Healthy Subjects(3 months)
- Change from Baseline in Glycemia in Healthy Subjects(3 months)
- Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome(6 months)
- Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome(6 months)
- Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome(6 months)
- Change from Baseline in Body Mass Index (BMI) in Healthy Subjects(3 months)
- Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome(6 months)
- Change from Baseline in Glycated Haemoglobin in Healthy Subjects(3 months)
- Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome(6 months)
研究者
Giuseppe Montalto
MD, Full Professor
University of Palermo