Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Iron bio-availability from Oral Iron Supplements
研究概览
简要总结
Previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic phytic acid removal through phytase. The investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (LNS) products compared to micronutrient powder(MNP) products.
Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Reproductive age females 18-45 years
- •Normal body mass index (17.5-25 kg/m2)
- •No intake of mineral/vitamin supplements 2 weeks before and during the study
- •No metabolic or gastrointestinal disorders
- •No food allergies or other chronic disorders or eating disorders assessed by self-report
- •Having received full oral and written information about the aims and procedures of the study
- •Willing to comply with the study procedure
- •Having provided oral and written informed consent
排除标准
- •Regular intake of medication (except oral contraceptives)
- •Blood donation or significant blood loss (accident, surgery) over the past 4 months
- •Currently participating in another clinical trial or having participated in another clinical trial during the last 30 days prior to the beginning of this study
- •Former participation in a study involving administration of iron stable isotopes
- •Subject who cannot be expected to comply with study protocol
- •Pregnancy or lactation
研究组 & 干预措施
FePP-Emulsion mixed
Fat emulsion mixed to the meal containing FePP
干预措施: Iron pyrophosphate (FePP) (Dietary Supplement)
LNS
Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
干预措施: micronutrient powder (Dietary Supplement)
FePP-Emulsion before
Fat emulsion taken before a meal containing FePP
干预措施: Iron pyrophosphate (FePP) (Dietary Supplement)
LNS-Phytase
Maize meal mixed with LNS containing micronutrient powder and phytase
干预措施: micronutrient powder (containing FeSO4), phytase (Dietary Supplement)
phytase
Maize meal containing micronutrient powder and phytase
干预措施: micronutrient powder (containing FeSO4), phytase (Dietary Supplement)
MNP-control
maize meal containing micronutrient powder (MNP)
干预措施: micronutrient powder (Dietary Supplement)
FePP control
Maize meal containing FePP
干预措施: Iron pyrophosphate (FePP) (Dietary Supplement)
FeSO4 control
Maize meal containing FeSO4
干预措施: Iron sulphate (Dietary Supplement)
FeSO4- Emulsion before
Fat emulsion taken before a maize meal containing FeSO4
干预措施: Iron sulphate (Dietary Supplement)
FeSO4-Mixed
meals containing FeSO4 mixed with a fat emulsion
干预措施: Iron sulphate (Dietary Supplement)
结局指标
主要结局
Iron bio-availability from Oral Iron Supplements
时间窗: 14 days
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood 14 days after administration will be measured with mass spectrometry.
次要结局
未报告次要终点
研究者
Prof. Michael B. Zimmermann
Prof
Swiss Federal Institute of Technology