Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of natural supplement on metabolic parameters including waist circumference
研究概览
简要总结
Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.
详细描述
This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.
The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.
All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement 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
- 否
入选标准
- •Men and women aged >18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
- •BMI> 25 kg/m^2;
- •Subjects able to swallow whole tablets;
- •Informed consent obtained prior to any study-related activities.
排除标准
- •Pregnancy or willingness to become pregnant;
- •Severe liver dysfunction (ALT >2.5 times upper limit of normal);
- •Severe renal failure (eGFR<60 mL/min/1.73 m2 using the MDRD formula);
- •Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
- •History or presence of malignant neoplasms within the last 5 years.
研究组 & 干预措施
Dietary Supplement
50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die)
干预措施: Natural supplement containing chlorogenic acid and luteolin (Dietary Supplement)
Placebo
50 subjects with the metabolic syndrome receiving placebo (without any active ingredients)
干预措施: Placebo (without any active ingredients) (Other)
结局指标
主要结局
Effect of natural supplement on metabolic parameters including waist circumference
时间窗: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm).
Effect of natural supplement on metabolic parameters including plasma lipids
时间窗: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula.
Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)
时间窗: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m\^2.
Effect of natural supplement on metabolic parameters including glucose metabolism parameters
时间窗: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l).
Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index
时间窗: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index.
次要结局
- Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis(Change from baseline to 6 months of the supplementation)
- Effect of natural supplement on cardio-metabolic parameters including plasma cytokines(Change from baseline to 6 months of the supplementation)
- Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins(Change from baseline to 6 months of the supplementation)
- Effect of natural supplement on cardio-metabolic parameters including fatty liver index(Change from baseline to 6 months of the supplementation)
研究者
Manfredi Rizzo
MD, PhD, Associate Professor
University of Palermo