安定化ラクトフェリンからの鉄吸収：鉄欠乏症女性における研究 (LOBSTER)
安定化ラクトフェリンからの鉄吸収：鉄欠乏女性における実験的研究（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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Zurich、スイス、8092
- ETH Zurich, Laboratory of Clinical Biopharmacy
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Ferrous sulfate + inhibitory meal
4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal |
Maize porridge with labelled ferrous sulfate (58Fe) |
|
アクティブコンパレータ：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 |
|
実験的：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 |
|
実験的：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) |
|
実験的：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 |
|
実験的：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) |
|
実験的：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) |
|
実験的：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) |
|
アクティブコンパレータ：Ferrous sulfate + water
100 mg of iron as ferrous sulfate + water |
Water with ferrous sulfate (labelled with iron isotope 58Fe) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fractional iron absorption (%)
時間枠：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
|
|
Fractional iron absorption (%)
時間枠：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
|
|
Fractional iron absorption (%)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hemoglobin (g/dL)
時間枠：Day 1
|
Iron status marker |
Day 1
|
|
Hemoglobin (g/dL)
時間枠：Day 22
|
Iron status marker |
Day 22
|
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Hemoglobin (g/dL)
時間枠：Day 43
|
Iron status marker |
Day 43
|
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Hemoglobin (g/dL)
時間枠：Day 64
|
Iron status marker |
Day 64
|
|
Serum Ferritin (µg/L)
時間枠：Day 1
|
Iron status marker |
Day 1
|
|
Serum Ferritin (µg/L)
時間枠：Day 22
|
Iron status marker |
Day 22
|
|
Serum Ferritin (µg/L)
時間枠：Day 43
|
Iron status marker |
Day 43
|
|
soluble Transferrin Receptor (mg/L)
時間枠：Day 1
|
Iron status marker |
Day 1
|
|
soluble Transferrin Receptor (mg/L)
時間枠：Day 22
|
Iron status marker |
Day 22
|
|
soluble Transferrin Receptor (mg/L)
時間枠：Day 43
|
Iron status marker |
Day 43
|
|
C-reactive protein (mg/L)
時間枠：Day 1
|
Chronic inflammation marker |
Day 1
|
|
C-reactive protein (mg/L)
時間枠：Day 22
|
Chronic inflammation marker |
Day 22
|
|
C-reactive protein (mg/L)
時間枠：Day 43
|
Chronic inflammation marker |
Day 43
|
|
Alpha-1-acid Glycoprotein (g/L)
時間枠：Day 1
|
Acute inflammation marker |
Day 1
|
|
Alpha-1-acid Glycoprotein (g/L)
時間枠：Day 22
|
Acute inflammation marker |
Day 22
|
|
Alpha-1-acid Glycoprotein (g/L)
時間枠：Day 43
|
Acute inflammation marker |
Day 43
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nicole Ursula Stoffel, Prof.、ETH Zurich
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。