Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Serum iron
研究概览
简要总结
Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.
详细描述
In a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. Prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. Following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. After two weeks other treatments were administered to each participant. The serum iron response curves for each treatment were constructed and the area under the curve (AUC) was calculated with the change of serum iron from baseline.
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, Investigator)
盲法说明
Both investigators and participants were blinded to the iron treatment in this double-blinded, crossover study. Three different iron supplements were given, whereby participants were either administered 10 mg FeSO4, 10 mg ASP Fe, or 20 mg ASP Fe.
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-pregnant
- •Non-lactating
- •Non-smoker
- •Not taking medications
- •Not taking dietary supplements (vitamins or minerals)
- •No history of gastrointestinal conditions
排除标准
- •Any history of gastrointestinal conditions
- •On medications that interfere with iron absorption
- •Unwilling to stop taking dietary supplements (vitamins or minerals)
- •Lactating
结局指标
主要结局
Serum iron
时间窗: 12 hours
Area under the curve
次要结局
未报告次要终点
研究者
Dr. Manju B. Reddy
Professor
Iowa State University
