稳定乳铁蛋白中铁的吸收：一项针对缺铁女性的研究 (LOBSTER)
稳定乳铁蛋白的铁吸收：一项针对缺铁女性的实验性研究（LOBSTER）
Lactoferrin (LF) is a natural iron-binding protein found in milk. It exists either in an iron-free state (apo-LF) or bound to iron (holo-LF). Whether LF binds iron to facilitate its absorption and/or to sequester iron from potential enteropathogens remains uncertain. However, while LF is a promising tool for treating iron deficiency, it is sensitive to heat during food processing and to the acidic environment of the human stomach. This degradation often causes LF to lose its functional properties before it can promote iron absorption effectively.
This study aims to evaluate whether encapsulating apo-LF (either alone or in combination with iron) can protect LF from digestion and enhance iron absorption. Using a randomized, crossover design, different encapsulation methods will be compared to determine which results in the highest iron absorption in women with iron deficiency.
All test compounds will be labeled with stable iron isotopes. Participants will consume the labeled compounds with a test meal or water in a randomized order, allowing for within subject comparisons. Fractional iron absorption will be measured 17 days after administration via the incorporation of labeled iron into red blood cells.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Zurich、瑞士、8092
- ETH Zurich, Laboratory of Clinical Biopharmacy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Serum ferritin < 45 µg/L (iron depleted)
- Body weight < 70 kg
- Body mass index 18,5 - 24,9 kg/m2 (normal weight)
- Hemoglobin (Hb) > 120 g/L (nonanemic)
- C-reactive protein (CRP) < 5 mg/L (no inflammation)
Exclusion Criteria:
- Pregnant or lactating
- Strictly vegan
- Cigarette smoking (> 1 cigarette / week)
- Gastrointestinal or metabolic disorders affecting iron absorption or metabolism
- Use of medication known to affect iron metabolism (oral contraceptives are allowed)
- Intake of vitamin and mineral supplements in the 2 weeks before study start and during the study
- Blood transfusion, blood donation, or significant blood loss during the previous 4 months
- once enrolled, inability to follow study procedures or major illness
- Participation in another study with investigational drug within the 30 days preceding and during the present study
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) |
|
有源比较器：Ferrous sulfate + native LF + inhibitory meal
4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) and lactoferrin |
|
实验性的：Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory meal
4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal |
Maize porridge with labelled ferrous sulfate (57Fe) and in sodium caseinate encapsulated lactoferrin |
|
实验性的：Encapsulated LF-Fe (Sodium caseinate) + inhibitory meal
4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal |
Maize porridge with sodium caseinate-lactoferrin-Fe (intrinsically labeled with iron isotope 54) |
|
实验性的：Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory meal
4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal |
Maize porridge with labelled ferrous sulfate (54Fe) and low methoxy pectin lactoferrin |
|
实验性的：Encapsulated LF-Fe (low methoxy pectin) + inhibitory meal
4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal |
Maize porridge with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57) |
|
实验性的：Encapsulated LF-Fe (sodium caseinate) + water
100 mg of iron encapsulated with LF in sodium caseinate + water |
Water with sodium caseinate-lactoferrin-Fe (intrinsically labelled with iron isotope 54Fe) |
|
实验性的：Encapsulated LF-Fe (low methoxy pectin) + water
100 mg of iron encapsulated with LF in low methoxy pectin + water |
Water with low methoxy pectin-lactoferrin-Fe (intrinsically labelled with iron isotope 57Fe) |
|
有源比较器：Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water |
Water with ferrous sulfate (labelled with iron isotope 58Fe) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fractional iron absorption (%)
大体时间：Day 22
|
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 17 days after intake compared to baseline. |
Day 22
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Fractional iron absorption (%)
大体时间：Day 43
|
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 17 days after intake compared to day 22. |
Day 43
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Fractional iron absorption (%)
大体时间：Day 64
|
Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 17 days after intake compared to day 43. |
Day 64
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hemoglobin (g/dL)
大体时间：Day 1
|
Iron status marker |
Day 1
|
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Hemoglobin (g/dL)
大体时间：Day 22
|
Iron status marker |
Day 22
|
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Hemoglobin (g/dL)
大体时间：Day 43
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Iron status marker |
Day 43
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Hemoglobin (g/dL)
大体时间：Day 64
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Iron status marker |
Day 64
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Serum Ferritin (µg/L)
大体时间：Day 1
|
Iron status marker |
Day 1
|
|
Serum Ferritin (µg/L)
大体时间：Day 22
|
Iron status marker |
Day 22
|
|
Serum Ferritin (µg/L)
大体时间：Day 43
|
Iron status marker |
Day 43
|
|
soluble Transferrin Receptor (mg/L)
大体时间：Day 1
|
Iron status marker |
Day 1
|
|
soluble Transferrin Receptor (mg/L)
大体时间：Day 22
|
Iron status marker |
Day 22
|
|
soluble Transferrin Receptor (mg/L)
大体时间：Day 43
|
Iron status marker |
Day 43
|
|
C-reactive protein (mg/L)
大体时间：Day 1
|
Chronic inflammation marker |
Day 1
|
|
C-reactive protein (mg/L)
大体时间：Day 22
|
Chronic inflammation marker |
Day 22
|
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C-reactive protein (mg/L)
大体时间：Day 43
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Chronic inflammation marker |
Day 43
|
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Alpha-1-acid Glycoprotein (g/L)
大体时间：Day 1
|
Acute inflammation marker |
Day 1
|
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Alpha-1-acid Glycoprotein (g/L)
大体时间：Day 22
|
Acute inflammation marker |
Day 22
|
|
Alpha-1-acid Glycoprotein (g/L)
大体时间：Day 43
|
Acute inflammation marker |
Day 43
|
合作者和调查者
调查人员
- 首席研究员：Nicole Ursula Stoffel, Prof.、ETH Zurich
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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