NCT01925547已完成2 期
Effect of Micellar Curcumin on Inflammation and Lipid Metabolism Markers
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- C-reactive protein (CRP)
研究概览
简要总结
The purpose of this study is to investigate the effect of micellar curcumin on inflammation and lipid metabolism markers in subjects at risk for the metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Total cholesterol > 5.2 mmol/L
- •LDL cholesterol > 3.4 mmol/L
- •Triglyceride > 2.26 mmol/L
- •CRP > 2 mg/L
排除标准
- •Intake of drugs or dietary supplements
- •Pregnant women and breastfeeding mothers
- •Previous illnesses such as heart attack, cancer or dementia
- •Addiction
研究组 & 干预措施
Micellar curcumin
Experimental
Subjects receive three times per day four capsules of curcumin micelles. One capsule contains 20 mg of curcumin. At the beginning, after three and six weeks of intake, blood samples are collected.
干预措施: Micellar curcumin (Dietary Supplement)
Placebo
Placebo Comparator
Subjects receive three times per day four capsules of placebo preparation. At the beginning, after three and six weeks of intake, blood samples are collected.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
C-reactive protein (CRP)
时间窗: At baseline and 6 weeks
Serum CRP in mg/L
次要结局
- Plasma curcumin concentrations(At baseline and 6 weeks)
- Serum total cholesterol(At baseline and 6 weeks)
- Serum HDL cholesterol(At baseline and 6 weeks)
- Serum LDL cholesterol(At baseline and 6 weeks)
- Serum aspartate transaminase activity(At baseline and 6 weeks)
- Plasma interleukine 6(At baseline and 6 weeks)
- Body weight(At baseline and 6 weeks)
- Serum alanine transaminase activity(At baseline and 6 weeks)
- Fasting blood glucose(At baseline and 6 weeks)
- Serum insulin(At baseline and 6 weeks)
- Systolic blood pressure(At baseline and 6 weeks)
- Serum uric acid(At baseline and 6 weeks)
- Serum triacylglycerols(At baseline and 6 weeks)
- Serum gamma glutamyl transferase activity(At baseline and 6 weeks)
- Serum alkaline phosphatase activity(At baseline and 6 weeks)
- Diastolic blood pressure(At baseline and 6 weeks)
- Plasma tumor necrosis factor alpha(At baseline and 6 weeks)
- Plasma albumin(At baseline and 6 weeks)
- Serum bilirubin(At baseline and 6 weeks)
- Serum creatinine(At baseline and 6 weeks)
研究者
Jan Frank
Professor, Ph.D.
University of Hohenheim
研究点 (1)
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