NCT05188430Unknown不适用
A Double-blind, Randomized, Placebo-controlled Clinical Trial on the Metabolic Effect of an Innovative Chitosan Formulation
University of Bologna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Absolute change in LDL-C from baseline and between groups
研究概览
简要总结
Chitosan is a natural polysaccharide of β-1,4-linked glucosamine residues deriving from chitin, a dietary fiber primarily obtained from fungal cell walls and the exoskeletons of various crustaceans (e.g. crab, lobster, and shrimp) and whose cholesterol-lowering properties are due to the hydrophobic bonds it forms with cholesterol and other sterols, interfering with the emulsification process in the intestine.
In addition to reducing low-density lipoprotein cholesterol (LDL-C) levels, several studies showed that chitosan administration may help reduce body weight. For this reason, its use might be particularly useful as a strategy to simultaneously control two different risk factors for the development of CVDs.
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;
- •Subjects free from cardiovascular diseases (CVDs) (primary prevention for CVDs);
- •Subjects with sub-optimal serum levels of cholesterol (total cholesterol (TC) of 200-240 mg/dl OR LDL-C of 130-190 mg/dl);
- •Subjects with body mass index (BMI) 25 -34.9 Kg/m2
排除标准
- •Subjects already affected by CVDs (secondary prevention for CVDs);
- •Subjects with serum levels of triglycerides (TG)> 400 mg/dl;
- •Type 1 or type 2 diabetes;
- •Lipid-lowering treatment not stabilized since at least 2 months;
- •Known current gastrointestinal diseases and use of medications for their treatment;
- •Known clinically relevant decline in renal function;
- •Women in fertile age not using consolidated contraceptive methods
- •Pregnancy and Breastfeeding;
- •History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- •Any medical or surgical condition that would limit the patient adhesion to the study protocol
结局指标
主要结局
Absolute change in LDL-C from baseline and between groups
时间窗: 12 weeks
Absolute change in LDL-C after 12 weeks of treatment with MD compared to placebo
次要结局
- Absolute change in HOMA-IR index from baseline and between groups(12 weeks)
- Absolute change in lipids ratios from baseline and between groups(12 weeks)
- Absolute change in fasting plasma glucose (FPG) from baseline and between groups(6 weeks)
- Absolute change in homeostatic model assessment for insuline resistance (HOMA-IR) index from baseline and between groups(6 weeks)
- Absolute change in LDL-C from baseline and between groups(6 weeks)
- Absolute change in lipid accumulation product (LAP) from baseline and between groups(6 weeks)
- Absolute change in index of visceral adiposity index (VAI) from baseline and between groups(12 weeks)
- Absolute change in body mass index (BMI) from baseline and between groups(6 weeks)
- Absolute change in serum lipids other than LDL-C (TC, TG, HDL-C, non-HDL-C) and apolipoproteins from baseline and between groups(6 weeks)
- Absolute change in LAP from baseline and between groups(12 weeks)
- Absolute change in fasting plasma insulin from baseline and between groups(12 weeks)
- Absolute change in waist circumference from baseline and between groups(12 weeks)
- Absolute change in index of central obesity (ICO) from baseline and between groups(12 weeks)
- Absolute change in fasting insulin from baseline and between groups(6 weeks)
- Absolute change in weight from baseline and between groups(6 weeks)
研究者
Arrigo F.G. Cicero
Professor
University of Bologna
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Crossover Trial of Chitosan Oligosaccharide on Post Prandial Glucose Control in Subjects With Normal, IFG and IGTNormalImpaired Fasting GlucoseImpaired Glucose ToleranceNCT03650023Yonsei University37
已完成
2 期
effects of chitosan solution in the treatment of fungal infection due to dentureOral fungal infection.Candidal stomatitisIRCT2015071223169N1Research center of Kerman Dental School40
已完成
3 期
the effect of chitosan in periodontal intra bony defectIRCT20100427003813N8Babol University of Medical Sciences18
已完成
2 期
Chitosan supplementation and CoronavirusIRCT20210510051243N1Arak University of Medical Sciences80
已完成
2 期
Efficacy and Safety of HEP-40 Chitosan for Mild to Moderately Elevated CholesterolHypercholesterolemiaNCT00454831DNP Canada207