NCT01489592已完成2 期
Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximal variation of serum hepcidin level after oral administration of curcumin
研究概览
简要总结
The purpose of this study is to determine the impact of curcumin, administrated orally, on iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin expression that the investigators observed in vitro and serum hepcidin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 18 et 25 Kg/m²
- •Non smoker
- •No swallowing disorders
- •Normal clinical exam
- •Normal ECG
- •Normal values for routine biological tests : serum iron, transferrin saturation,, hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol, triglycerides
- •No C282Y mutation within the HFE gene
- •Affiliation to social security
- •Written informed consent obtained
排除标准
- •Chronic or evolutive disease
- •Infection during the 7 days before each sequence
- •Drug or alcohol (>30g) abuse
- •Current treatment
- •Known food allergy
- •stay at altitude (> 1500m) in 2 months
- •Positive serology for hepatitis B or C virus or HIV.
- •Transfusion or blood donation during the last three months.
- •Exclusion period on the healthy volunteer National File.
研究组 & 干预措施
curcumin
Experimental
oral administration of 6g of curcumin
干预措施: curcuma longa (Drug)
placebo
Placebo Comparator
oral administration of 12 sugar pill
干预措施: curcuma longa (Drug)
结局指标
主要结局
Maximal variation of serum hepcidin level after oral administration of curcumin
时间窗: within 48 hours after administration of curcumin
次要结局
- Plasmatic iron bioavailability(30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H)
- Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes(30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h)
研究者
研究点 (1)
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