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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron chlorophyllin + Water | Experimental | 3 mg iron as Fe chlorophyllin (54Fe) + water |
|
| Soy hemoglobin + Water | Experimental | 3 mg iron as soy hemoglobin (58Fe) + water |
|
| Ferrous sulfate + Water (negative control) | Active Comparator | 3 mg iron as ferrous sulfate (58Fe) + water |
|
| Porcine hemoglobin + Water (positive control) | Active Comparator | 3 mg iron as porcine hemoglobin (57Fe) + water |
|
| Iron Chlorophyllin + Inhibitory Meal | Experimental | 3 mg iron as Fe chlorophyllin (54Fe) + maize porridge |
|
| Soy Hemoglobin + Inhibitory Meal | Experimental | 3 mg iron as soy hemoglobin (58Fe) + maize porridge |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron chlorophyllin + no-matrix | Other | Water with labelled Fe chlorophyllin (54Fe) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fractional Iron Absorption (percent) | 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. | Day 22 |
| Fractional Iron Absorption (percent) | 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. | Day 43 |
| Fractional Iron Absorption (percent) | 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. | Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (g/dL) | Iron status marker | Day 1 |
| Hemoglobin (g/dL) | Iron status marker | Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETH Zurich, Laboratoy of Clinical Biopharmacy | Zurich | 8092 | Switzerland |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Ferrous sulfate + Inhibitory Meal (negative control) | Active Comparator | 3 mg iron as ferrous sulfate (57Fe) + maize porridge |
|
| Porcine hemoglobin + Inhibitory Meal (positive control) | Active Comparator | 3 mg of iron as porcine hemoglobin (57Fe) + maize porridge |
|
| SoyHb + no-matrix | Other | Water with labelled soy hemoglobin (58Fe) |
|
| FeSO4 + no-matrix | Other | Water with labelled ferrous sulfate (58Fe) |
|
| Hb + no-matrix | Other | Water with labelled porcine hemoglobin (57Fe) |
|
| Iron chlorophyllin + meal-matrix | Other | Maize porridge with labelled Fe chlorophyllin (54Fe) |
|
| SoyHb + meal-matrix | Other | Maize porridge with labelled soy hemoglobin (58Fe) |
|
| FeSO4 + meal-matrix | Other | Maize porridge with labelled ferrous sulfate (57Fe) |
|
| Hb + meal-matrix | Other | Maize porridge with labelled porcine hemoglobin (57Fe) |
|
| Hemoglobin (g/dL) | Iron status marker | Day 43 |
| Hemoglobin (g/dL) | Iron status marker | Day 64 |
| Serum Ferritin (µg/L) | Iron status marker | Day 1 |
| Serum Ferritin (µg/L) | Iron status marker | Day 22 |
| Serum Ferritin (µg/L) | Iron status marker | Day 43 |
| soluble Transferrin Receptor (mg/L) | Iron status marker | Day 1 |
| soluble Transferrin Receptor (mg/L) | Iron status marker | Day 22 |
| soluble Transferrin Receptor (mg/L) | Iron status marker | Day 43 |
| C-reactive protein (mg/L) | Chronic inflammation marker | Day 1 |
| C-reactive protein (mg/L) | Chronic inflammation marker | Day 22 |
| C-reactive protein (mg/L) | Chronic inflammation marker | Day 43 |
| Alpha-1-acid Glycoprotein (g/L) | Acute inflammation marker | Day 1 |
| Alpha-1-acid Glycoprotein (g/L) | Acute inflammation marker | Day 22 |
| Alpha-1-acid Glycoprotein (g/L) | Acute inflammation marker | Day 43 |
| Hepcidin (ng/mL) | A major regulator of iron absorption | Day 1 |
| Hepcidin (ng/mL) | A major regulator of iron absorption | Day 22 |
| Hepcidin (ng/mL) | A major regulator of iron absorption | Day 43 |