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临床试验/NCT06822062
NCT06822062招募中不适用

The Effect of Chitin and Ascorbic Acid on Dietary Iron Absorption From Tenebrio Molitor Larvae in Young Women.

Swiss Distance University of Applied Sciences1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年5月6日最近更新:
适应症
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
25
试验地点
1
主要终点
Fractional iron absorption

研究概览

简要总结

Iron is involved in many vital metabolic processes such as oxygen transport, electron transport in cells, DNA synthesis and repair, and muscle metabolism. However, iron deficiency and iron deficiency anemia continue to affect many people, particularly preschool children (<5 years), adolescents, and pregnant and non-pregnant women of childbearing age. Iron deficiency is characterized by a lack of total iron stores in the body, which is mainly caused by insufficient dietary iron intake, physiologically increased iron requirements, poor intestinal iron absorption, or chronic blood loss. Animal foods are important sources of highly bioavailable iron in the human diet. Meeting human nutritional needs for the rapidly increasing world population while targeting food production within the planetary boundaries will require the identification of sustainable iron sources, such as edible insects. A previous iron absorption study showed that insect iron is absorbed moderately well. The present study will examine if and to which extent chitin, a polysaccharide within the insect biomass, inhibits iron absorption. In addition, the enhancing iron absorption of ascorbic acid on iron absorption from Tenebrio molitor larvae will be studied. This knowledge can support to optimize the composition of an insect-based meal to increase its iron absorption.

To distinguish iron absorption from insect biomass from other sources, insects are labeled with stable iron isotopes (Fe-57, Fe-58, Fe-54) and iron absorption in the blood is measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The randomization will be single-blinded, i.e., the participants will not know which type of test meal they will be given on which study visit.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female aged between 18-45 years
  • •Normal BMI (18.5 - 24.9 kg/m2)
  • •Body weight < 70 kg
  • •Low iron status (being in the lower half of the serum ferritin distribution at screening)

排除标准

  • •Anaemia (Hb < 12 g/dL)
  • •Inflammation (CRP > 5.0 mg/L)
  • •Pregnancy or intention to become pregnant during the study or within 30 days after the discontinuation of the study intervention
  • •Lactating up to 6 weeks before the study initiation
  • •Chronic digestive, renal and/or metabolic diseases
  • •Antibiotics in the last 4 weeks prior to the study and during the study
  • •Mineral and vitamin supplementation in the last 2 weeks prior to the study and during the course of the study
  • •Chronic medication intake (except for oral contraceptives)
  • •Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
  • •Earlier participation in a study using stable isotopes or in any clinical study within the last 30 days
  • •Food allergies, especially known hypersensitivity to crustacea, dust mites, sea food, gluten, milk, or eggs
  • •Cigarette smoking (> 1 cigarette per day)

研究组 & 干预措施

T.molitor native chitin

Experimental

Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor

干预措施: Meal A (Other)

T.molitor high chitin level

Experimental

Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + 2g chitin of shrimp origin

干预措施: Meal B (Other)

T.molitor + Ascorbic Acid

Experimental

Vegetable soup prepared with dried 57-Fe intrinsically labeled T.molitor + Ascorbic acid (4:1 ascorbic acid to iron molar ratio)

干预措施: Meal C (Other)

Control meal

Experimental

Vegetable soup with addition of labelled FeSO4 (isotope iron 58)

干预措施: Meal D (Other)

Control meal low chitin

Experimental

Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 1g chitin of shrimp origin

干预措施: Meal E (Other)

Control meal high chitin

Experimental

Vegetable soup with addition of labelled FeSO4 (isotope iron 58) + 3g chitin of shrimp origin

干预措施: Meal F (Other)

Control meal + Ascorbic Acid

Experimental

Vegetable soup with addition of labelled FeSO4 (isotope iron 54) + Ascorbic acid (4:1 ascorbic acid to iron molar ratio)

干预措施: Meal G (Other)

结局指标

主要结局

Fractional iron absorption

时间窗: screening (-1), 16th, 32nd,47th day of the study

Fractional iron absorption will be calculated based on the shift in iron isotope ratio in red blood cells 14 to 16 days post administration of the isotopically labelled meals. Calculation of fractional iron absorption will take into account the principles of isotope dilution and the fact that iron isotopic labels are not monoisotopic.

次要结局

  • Serum Ferritin (SF)(screening (-1), 16th, 32nd, 47th day of the study)
  • Serum Transferrin Receptor (sTfR)(screening (-1), 47th day of the study)
  • C-Reactive Protein (CRP)(screening (-1), 16th, 32nd, 47th day of the study)
  • alpha-1-acid glycoprotein (AGP)(screening (-1), 47th day of the study)
  • Retinol binding Protein (RBP)(screening (-1), 47th day of the study)
  • Hemoglobin (Hb)(screening (-1), 16th, 32nd, 47th day of the study)

研究者

发起方
Swiss Distance University of Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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