Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products
研究概览
简要总结
The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy female subjects;
- •Age > 18 and < 40 years at screening;
- •Body weight <65 kg;
- •Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- •With iron deficiency (Serum ferritin <15µg/L);
- •Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
- •Willing and able to participate in the study; Having given a written informed consent.
排除标准
- •Blood donation or significant blood loss over the past 6 months;
- •Reported use of any medically- or self-prescribed diet;
- •Use of medication (except oral contraceptives)
- •Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
- •Is pregnant or will be planning pregnancy during the study period;
- •Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
- •Known gastrointestinal or metabolic disorders;
- •Participation in another clinical trial during the last 30 days prior to the beginning of the study.
研究组 & 干预措施
Fortified savoury food product 4
Savoury food product fortified with iron
干预措施: Savoury food product (Other)
Fortified savoury food product 1
Savoury food product fortified with iron
干预措施: Savoury food product (Other)
Fortified savoury food product 2
Savoury food product fortified with iron
干预措施: Savoury food product (Other)
Fortified savoury food product 3
Savoury food product fortified with iron
干预措施: Savoury food product (Other)
结局指标
主要结局
To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products
时间窗: 15 days
Amounts of Fe isotopic label present in the blood 14 days after administration of the fortified savoury food product will be calculated based on measured shifts in the iron isotope ratios in the blood samples (Day 15) compared to baseline and the amount of iron circulating in the body
次要结局
- To assess the relative bioavailability of iron from iron fortified savoury food products(15 days)