Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- iron absorption
研究概览
简要总结
The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.
详细描述
Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value <30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
When 57Fe was added to a meal an empy capsule was consumed by the subjects. 58Fe and natutal abundace iron associated with A. oryzae was consumed in capsule form.
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
- •Marginal iron status (Serum ferritin <30ug/L)
- •BMI in the range 18.5-24.9 kg/m2
- •Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study
- •Willing to consume stable iron isotope labelled supplement
- •Willing to stop getting blood drawn 2 weeks prior to the study and during the study
- •Willing to give multiple blood samples at beginning and end of study
排除标准
- •Lactating
- •Anemic (hemoglobin < 120 g/L)
- •Has gastro-intestinal disease/condition that can affect absorption
- •Allergic to any of the meal components
研究组 & 干预措施
Aspiron
The Asprion group was required to follow the same protocol as the 57Fe experimental group, with the exception of taking A. Oryzae containing (8 mg natural abundace Fe and 2 mg 58Fe. Meals composition was similar to ferrous sulafte group.
干预措施: Aspiron (Dietary Supplement)
Ferrous Sulfate
The ferrous sulfate group was required to consume a test containing ferrous sulfate (10 mg of 57Fe). Participants received a meal containing 17.6 g egg albumin, 45 g corn syrup solids, 17.5 g corn oil, 6 ml vanilla extract, and 100 ml of distilled water.
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
iron absorption
时间窗: 15 days
Isotope enrichment in the blood samples
次要结局
- iron status(15 days)
研究者
Dr. Manju B. Reddy
Professor
Iowa State University