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Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes.
Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| free FeSO4 | Experimental | wheat bread fortified with free FeSO4 |
|
| free FeSO4 and empty microspheres | Experimental | wheat bread fortified with free FeSO4, and empty microspheres |
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| free FeSO4 with eudragit polymer | Experimental | wheat bread fortified with free FeSO4, and eudragit polymer |
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| free FeSO4 with Hyaluronic Acid | Experimental | wheat bread fortified with free FeSO4, and hyaluronic acid |
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| encapsulated FeSO4 3.2% | Experimental | wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading |
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| encapsulated FeSO4 20% | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| free FeSO4 | Dietary Supplement | Testmeal with free FeSO4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the isotopic ratio of iron in blood at week 2 | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. | baseline, 2 weeks |
| Change from week 2 in the isotopic ratio of iron in blood at week 4 | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. | 2 weeks, 4 weeks |
| Change from week 4 in the isotopic ratio of iron in blood at week 6 | The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes. | 4 weeks, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin | Haemoglobin of each timepoint | baseline, weeks 2, 4 and 6 |
| Plasma Ferritin | Plasma Ferritin of each timepoint | baseline, weeks 2, 4 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Laboratory, ETH Zurich | Zurich | 8092 | Switzerland |
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wheat bread fortified with encapsulated FeSO4 in a microsphere with 20% Fe loading |
|
| encapsulated FeSO4 3.2%, encap. Vitamin A | Experimental | wheat bread fortified with encapsulated FeSO4 in a microsphere with 3.2% Fe loading, and encapsulated Vitamin A as microspheres |
|
| encapsulated FeSO4 3.2%, encap. Vitamin A, free folicacid | Experimental | wheat bread fortified with encapsulated FeSO4 as microsphere with 3.2% Fe loading, encapsulated Vitamin A as microspheres and free folic acid |
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| FeSO4 embedded in Hyaluronic Acid | Experimental | wheat bread fortified with FeSO4 that is embedded in hyaluronic acid. |
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| free FeSO4 and empty microspheres |
| Dietary Supplement |
Testmeal with free FeSO4 and empty micropsheres |
|
| free FeSO4 and hylauronic acid | Dietary Supplement | Testmeal with free FeSO4 and hyaluronic acid |
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| free FeSO4 and eudragit polymer | Dietary Supplement | Testmeal with free FeSO4 and eudragit polymer |
|
| encapsulated FeSO4 3.2% | Dietary Supplement | Testmeal with encapsulated FeSO4 with 3.2% Fe loading |
|
| encapsulated FeSO4 20% | Dietary Supplement | Testmeal with encapsulated FeSO4 with 20% Fe loading |
|
| encapsulated FeSO4 3.2%, encapsulated Vitamin A | Dietary Supplement | Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A |
|
| encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid | Dietary Supplement | Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid. |
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| FeSO4 embedded in Hyaluronic acid | Dietary Supplement | Testmeal with FeSO4 embedded in Hyaluronic acid |
|
| inflammation marker | C reactive Protein of each timepoint | baseline, weeks 2, 4 and 6 |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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