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The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women (OTf)

2022年6月9日 更新者:Swiss Federal Institute of Technology

The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women With Non-anemic Iron Deficiency: Stable Isotope Study

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism. Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants [19]. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women.

OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

調査の概要

詳細な説明

Iron deficiency remains a major public health problem in both developed and developing countries. At present, iron deficiency is mostly combated with iron supplements in the form of iron salts, especially iron sulfate. Iron salts are absorbed via the nonhemic iron route via the DMT-1 receptor, the rate of absorption being 20% of the total iron content. The dietary supplement industry tries to counteract this problem and to supply the required amount of iron by increasing the iron concentration in the dietary supplements in order to compensate for the low absorption rate. However, the high dosage of iron leads to side effects. It would be more effective to maximize iron absorption rather than a high dose of iron. Chicken protein ovotransferrin (OTf) is recognized as an iron-binding protein and a member of the transferrin family. OTf has amino acid sequences that are identical to chicken serum transferrin and shows approximately 50% homology with mammalian transferrin and lactoferrin. Despite its iron binding properties and safety for human consumption, no studies have evaluated OTf as an enhancer of iron absorption in humans.

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism.

Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . There are various studies that show the iron bioavailability of intrinsically labeled holo-Lf and apo- Lf and FeSO4. Lf appears to be a good source of bioavailable iron in both infants and in adults. Whether this is due to iron absorption through the Lf receptor and/or due to iron released from Lf joining the common non-heme iron pool and being subsequently absorbed, remains uncertain. The high affinity of OTf for iron (∼1030 M-1) at pH 7.5 implies that in presence of apo-OTf, iron will be sequestered. Lf also possesses the ability to bind iron (binding constants of ∼1022-1024 M-1) and retain it at lower pH. This difference in iron binding capacity, however, is not sufficient to establish conclusive statements regarding the activity of OTf in iron absorption.

It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women. Furthermore, despite its iron-binding properties and safety for human consumption, to the best of our knowledge, no studies have assessed OTf as an enhancer of iron absorption in humans. Therefore the use of OTf and Lf as iron absorption enhancers by comparing fractional iron absorption with that of FeSO4, the most commonly used iron supplement is investigated. This study will provide information regarding iron absorption enhancement, as well the behavior of OTf and Lf in adult women.

OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

Participants are given OTf, Lf and iron sulfate solutions. To quantify this, stable iron isotopes are used as marker substances. Stable isotopes exist in nature and in our body and there are no risks associated with their ingestion. No changes in the iron status of the subjects are expected during the study.35 women of childbearing age are being recruited for the study.

研究の種類

介入

入学 (実際)

35

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Zurich、スイス、8092
        • ETH Zurich, Laboratory of Human Nutrition

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~45年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

  • female aged between 18-45 years old;
  • SF <25 µg / L;
  • BMI 18.5-24.9 kg / m2;
  • weight <70 kg;
  • signed informed consent;
  • Able to communicate and comprehend English language.

Exclusion Criteria:

  • Anemic (Hb <12 g / dL);
  • inflammation (CRP> 5 mg / L);
  • chronic digestive, renal and / or metabolic disease;
  • chronic medications (except for oral contraceptives);
  • use of vitamin, mineral and pre- and / or probiotic supplements in the previous 2 weeks and during the course of the study;
  • blood transfusion, blood donation or significant blood loss over the past 4 months;
  • difficulties with blood sampling;
  • antibiotic treatment in the previous 4 weeks before the start of the study and during the course of the study;
  • known hypersensitivity to egg;
  • pregnancy (tested in serum at screening) or intention to become pregnant during the course of the study;
  • lactation up to 6 weeks before study initiation;

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:処理
  • 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
他の:OTf + FeSO4
OTf + FeSO4 - This is the experimental arm where Ferrous sulfate will be given to the participants along with apo-Ovotransferrin, a potential iron absorption enhancer. They will be given as solutions that will be spread on bread with butter and honey, a breakfast meal.
OTf (apo ovotransferrin) + FeSO4
他の:Lf+ FeSO4
Lf + FeSO4 - This is the experimental arm where Ferrous sulfate will be given to the participants along with lactoferrin, a potential iron absorption enhancer. They will be given as solutions that will be spread on bread with butter and honey, a breakfast meal.
Lf (lactoferrin) + FeSO4
他の:FeSO4
FeSO4 - This is the control arm where Ferrous sulfate will be given in the form of a solution that will be spread on bread with butter and honey, as a breakfast meal
Ferrous sulfate

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 19th of the study
The primary outcome is iron bioavailability (as measured by erythrocyte incorporation of the stable isotope labels) from the 2 different conditions in the standardized test meals.
Day 19th of the study

二次結果の測定

結果測定
メジャーの説明
時間枠
Hemoglobin (Hb)
時間枠:Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
Serum ferritin (SF)
時間枠:Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
Serum transferrin receptor (sTfR),
時間枠:Screening (-14,) day 1 and day 19th
Iron status marker
Screening (-14,) day 1 and day 19th
C-reactive protein (CRP)
時間枠:Screening (-14,) day 1 and day 19th
Inflammation status
Screening (-14,) day 1 and day 19th

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Jessica Rigutto-Farebrother, PhD、Laboratory of Human Nutrition ETH Zürich

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年4月25日

一次修了 (実際)

2022年5月20日

研究の完了 (実際)

2022年5月20日

試験登録日

最初に提出

2021年10月29日

QC基準を満たした最初の提出物

2022年2月9日

最初の投稿 (実際)

2022年2月10日

学習記録の更新

投稿された最後の更新 (実際)

2022年6月10日

QC基準を満たした最後の更新が送信されました

2022年6月9日

最終確認日

2022年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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