Iron Absorption From Plant-Derived Heme Iron: An Experimental Study in Iron-Deficient Women (PHIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Fractional Iron Absorption (percent)
研究概览
简要总结
Heme, an iron protoporphyin IX complex, consists of a ferrous ion captured in a porphyrin ring acting as a tetradentate ligand. The unique features of heme iron -its unusually high absorption in foods and its resistance to luminal inhibitors of iron absorption- make it a potentially interesting iron fortificant. This study aims to compare fractional iron absorption from two plant-derived heme iron compounds-iron chlorophyllin and soy hemoglobin-with ferrous sulfate (negative control) and porcine hemoglobin (positive control) in iron-deficient women. All four compounds will be intrinsically labeled with stable iron isotopes. Fractional absorption will be assessed 14 days after test meal administration via erythrocyte iron incorporation.
Absorption will be tested in two matrices: water and maize porridge (an inhibitory matrix). Each participant will consume all test conditions in a randomized order, allowing for within-subject comparisons.
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)
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
- •Serum ferritin < 45 µg/L (iron depleted)
- •Body weight < 70 kg
- •Body mass index 18,5 - 24,9 kg/m2 (normal weight)
排除标准
- •Hb < 120 g/L (anemia)
- •CRP > 5 µg/L (inflammation)
- •Strict vegan and vegetarians
- •Any metabolic, gastrointestinal kidney or chronic disease
- •Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection
- •Blood transfusion over the past 6 months
- •blood donation over the past 6 months
- •Significant blood loss (accident, surgery) over the past 6 months
- •Women who are pregnant or breast feeding
- •Smoker (> 1 cigarette per week)
- •Continuous/long-term use of medication (except for contraceptives)
- •Therapeutic iron infusion over the past 6 months,
- •Known hypersensitivity or allergy to iron supplements,
- •Intention to become pregnant during the course of the studies,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the studies, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present studies,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Ferrous sulfate + Inhibitory Meal (negative control)
3 mg iron as ferrous sulfate (57Fe) + maize porridge
干预措施: FeSO4 + meal-matrix (Other)
Porcine hemoglobin + Inhibitory Meal (positive control)
3 mg of iron as porcine hemoglobin (57Fe) + maize porridge
干预措施: Hb + meal-matrix (Other)
Iron chlorophyllin + Water
3 mg iron as Fe chlorophyllin (54Fe) + water
干预措施: Iron chlorophyllin + no-matrix (Other)
Soy hemoglobin + Water
3 mg iron as soy hemoglobin (58Fe) + water
干预措施: SoyHb + no-matrix (Other)
Ferrous sulfate + Water (negative control)
3 mg iron as ferrous sulfate (58Fe) + water
干预措施: FeSO4 + no-matrix (Other)
Porcine hemoglobin + Water (positive control)
3 mg iron as porcine hemoglobin (57Fe) + water
干预措施: Hb + no-matrix (Other)
Iron Chlorophyllin + Inhibitory Meal
3 mg iron as Fe chlorophyllin (54Fe) + maize porridge
干预措施: Iron chlorophyllin + meal-matrix (Other)
Soy Hemoglobin + Inhibitory Meal
3 mg iron as soy hemoglobin (58Fe) + maize porridge
干预措施: SoyHb + meal-matrix (Other)
结局指标
主要结局
Fractional Iron Absorption (percent)
时间窗: Day 64
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Fractional Iron Absorption (%)
时间窗: Day 22
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Fractional Iron Absorption (%)
时间窗: Day 43
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Fractional Iron Absorption (%)
时间窗: Day 64
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
次要结局
- Hemoglobin (Hb)(Day 64)
- soluble Transferrin Receptor (sTfR)(Day 64)
- Serum Ferritin (SF)(Day 64)
- C-reactive protein (CRP)(Day 64)
- Alpha-1-acid Glycoprotein (AGP)(Day 64)
- 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)
- Hepcidin (ng/mL)(Day 1)
- Hepcidin (ng/mL)(Day 22)
- Hepcidin (ng/mL)(Day 43)
研究者
Nicole Stoffel
Assistantprofessor
ETH Zurich