안정화된 락토페린의 철분 흡수: 철분 결핍 여성을 대상으로 한 연구 (LOBSTER)
안정화 락토페린의 철분 흡수: 철분 결핍 여성에 대한 실험 연구 (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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zurich, 스위스, 8092
- ETH Zurich, Laboratory of Clinical Biopharmacy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) |
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활성 비교기: 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 |
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실험적: 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 |
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실험적: 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) |
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실험적: 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 |
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실험적: 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) |
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실험적: 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) |
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실험적: 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) |
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활성 비교기: Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water |
Water with ferrous sulfate (labelled with iron isotope 58Fe) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fractional iron absorption (%)
기간: Day 22
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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 (%)
기간: Day 43
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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 (%)
기간: Day 64
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hemoglobin (g/dL)
기간: Day 1
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Iron status marker |
Day 1
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Hemoglobin (g/dL)
기간: Day 22
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Iron status marker |
Day 22
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Hemoglobin (g/dL)
기간: Day 43
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Iron status marker |
Day 43
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Hemoglobin (g/dL)
기간: Day 64
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Iron status marker |
Day 64
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Serum Ferritin (µg/L)
기간: Day 1
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Iron status marker |
Day 1
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Serum Ferritin (µg/L)
기간: Day 22
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Iron status marker |
Day 22
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Serum Ferritin (µg/L)
기간: Day 43
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Iron status marker |
Day 43
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soluble Transferrin Receptor (mg/L)
기간: Day 1
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Iron status marker |
Day 1
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soluble Transferrin Receptor (mg/L)
기간: Day 22
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Iron status marker |
Day 22
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soluble Transferrin Receptor (mg/L)
기간: Day 43
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Iron status marker |
Day 43
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C-reactive protein (mg/L)
기간: Day 1
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Chronic inflammation marker |
Day 1
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C-reactive protein (mg/L)
기간: Day 22
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Chronic inflammation marker |
Day 22
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C-reactive protein (mg/L)
기간: Day 43
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Chronic inflammation marker |
Day 43
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Alpha-1-acid Glycoprotein (g/L)
기간: Day 1
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Acute inflammation marker |
Day 1
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Alpha-1-acid Glycoprotein (g/L)
기간: Day 22
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Acute inflammation marker |
Day 22
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Alpha-1-acid Glycoprotein (g/L)
기간: Day 43
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Acute inflammation marker |
Day 43
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Nicole Ursula Stoffel, Prof., ETH Zurich
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .