NCT03332641已完成不适用
A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Improvement of Blood Cholesterol
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes of Cholesterol
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Citron(Citrus Junos Siebold ex Tanaka) Peel Extract or a placebo group. Blood cholesterol profiles before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-75 years with Total cholesterol 200-239 mg/dL
排除标准
- •Lipid lowering agent within past 6 months
- •Severe cardiovascular disease(Mvodardial infarction, stroke, etc)
- •Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, ect)
- •Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
- •Diabetes mellitus
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of disease that could interfere with the test products or impede their absorption
- •Under antipsychotic drugs therapy within past 2 months
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test by show the following results
- •Pregnancy or breast feeding
- •Not Contraception(except: Surgery for female infertility)
研究组 & 干预措施
Citron peel Extract
Experimental
Citron peel extract for 12 weeks
干预措施: Citron peel extract (Dietary Supplement)
Placebo
Placebo Comparator
Placebo for 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes of Cholesterol
时间窗: 12 weeks
Changes of Cholesterol were assessed before and after the intervention
次要结局
- Changes of Lipid profile(12 weeks)
- Changes of Oxidized LDL(12 weeks)
研究者
Yongsoon Park
Professor
Hanyang University
研究点 (2)
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