Assessment of Iron Absorption From Aspergillus Oryzae

Study Overview
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Brief Summary
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The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.

Detailed Description
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Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value <30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.

Official Title
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Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate

Conditions
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Iron Bioavailability

Intervention / Treatment
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* Drug: Ferrous Sulfate
* Dietary Supplement: Aspiron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Marginal iron status (Serum ferritin <30ug/L) BMI in the range 18.5-24.9 kg/m2 Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study Willing to consume stable iron isotope labelled supplement Willing to stop getting blood drawn 2 weeks prior to the study and during the study Willing to give multiple blood samples at beginning and end of study Exclusion Criteria: Pregnant Lactating Smoker Anemic (hemoglobin < 120 g/L) Has gastro-intestinal disease/condition that can affect absorption Allergic to any of the meal components

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects were two meals on two consecutive days with the stable isotopes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferrous Sulfate<br>The ferrous sulfate group was required to consume a test containing ferrous sulfate (10 mg of 57Fe). Participants received a meal containing 17.6 g egg albumin, 45 g corn syrup solids, 17.5 g corn oil, 6 ml vanilla extract, and 100 ml of distilled water. | Drug: Ferrous Sulfate<br> <br> |
| Experimental: Aspiron<br>The Asprion group was required to follow the same protocol as the 57Fe experimental group, with the exception of taking A. Oryzae containing (8 mg natural abundace Fe and 2 mg 58Fe. Meals composition was similar to ferrous sulafte group. | Dietary Supplement: Aspiron<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron absorption | Isotope enrichment in the blood samples | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron status | hepcidin and ferritin | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron Bioavailability, hepcidin, ferritin, iron absorption, iron status