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临床试验/NCT07394972
NCT07394972招募中不适用

Iron Absorption From Stabilized Lactoferrin: An Experimental Study in Iron Deficient Women (LOBSTER)

Nicole Stoffel1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年2月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45
试验地点
1
主要终点
Fractional iron absorption (%)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Ferrous sulfate + inhibitory meal

Active Comparator

4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal

干预措施: FeSO4 + meal-matrix (Other)

Ferrous sulfate + native LF + inhibitory meal

Active Comparator

4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal

干预措施: FeSO4 + native LF + meal-matrix (Other)

Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory meal

Experimental

4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal

干预措施: FeSO4 + NaCas-LF + meal-matrix (Other)

Encapsulated LF-Fe (Sodium caseinate) + inhibitory meal

Experimental

4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal

干预措施: NaCas-LF-Fe + meal-matrix (Other)

Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory meal

Experimental

4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal

干预措施: FeSO4 + LMP-LF + meal-matrix (Other)

Encapsulated LF-Fe (low methoxy pectin) + inhibitory meal

Experimental

4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal

干预措施: LMP-LF-Fe + meal-matrix (Other)

Encapsulated LF-Fe (sodium caseinate) + water

Experimental

100 mg of iron encapsulated with LF in sodium caseinate + water

干预措施: NaCas-LF-Fe + water (Other)

Encapsulated LF-Fe (low methoxy pectin) + water

Experimental

100 mg of iron encapsulated with LF in low methoxy pectin + water

干预措施: LMP-LF-Fe + water (Other)

Ferrous sulfate + water

Active Comparator

100 mg of iron as ferrous sulfate + water

干预措施: FeSO4 + water (Other)

结局指标

主要结局

Fractional iron absorption (%)

时间窗: 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.

Fractional iron absorption (%)

时间窗: 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.

Fractional iron absorption (%)

时间窗: 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.

次要结局

  • Hemoglobin (g/dL)(Day 1)
  • Hemoglobin (g/dL)(Day 22)
  • Hemoglobin (g/dL)(Day 43)
  • Hemoglobin (g/dL)(Day 64)
  • Serum Ferritin (µg/L)(Day 1)
  • Serum Ferritin (µg/L)(Day 22)
  • Serum Ferritin (µg/L)(Day 43)
  • soluble Transferrin Receptor (mg/L)(Day 1)
  • soluble Transferrin Receptor (mg/L)(Day 22)
  • soluble Transferrin Receptor (mg/L)(Day 43)
  • C-reactive protein (mg/L)(Day 1)
  • C-reactive protein (mg/L)(Day 22)
  • C-reactive protein (mg/L)(Day 43)
  • Alpha-1-acid Glycoprotein (g/L)(Day 1)
  • Alpha-1-acid Glycoprotein (g/L)(Day 22)
  • Alpha-1-acid Glycoprotein (g/L)(Day 43)

研究者

发起方
Nicole Stoffel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicole Stoffel

Prof. Dr.

ETH Zurich

研究点 (1)

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