Iron Absorption From Iron-enriched Aspergillus Oryzae

Study Overview
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Brief Summary
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Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.

Detailed Description
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In a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. Prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. Following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. After two weeks other treatments were administered to each participant. The serum iron response curves for each treatment were constructed and the area under the curve (AUC) was calculated with the change of serum iron from baseline.

Official Title
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Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects

Conditions
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Iron-deficiency, Absorption; Iron, Anemia, Iron Deficiency, Bioavailability, Serum Iron

Intervention / Treatment
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* Dietary Supplement: Ferrous sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-pregnant Non-lactating Non-smoker Not taking medications Not taking dietary supplements (vitamins or minerals) No history of gastrointestinal conditions Exclusion Criteria: Any history of gastrointestinal conditions On medications that interfere with iron absorption Unwilling to stop taking dietary supplements (vitamins or minerals) Pregnant Lactating Smoker

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blinded, cross-over experimental design, whereby subjects were randomly given three different iron supplements with a meal in three different visits. All three visits (iron treatments) were each separated by two weeks time.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FeSO4<br>Ferrou sulfate: Each participant was given a one time oral dose of the 10 mg iron as ferrous sulfate with the test meal (described in study design) and serum iron was measured every 30 min for 4 hours. | Dietary Supplement: Ferrous sulfate<br>* The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.<br>* Other names: ASP (20 mg);|
| Experimental: ASP Fe (10 mg)<br>ASP (10 mg Fe): Each participants was given a one time oral dose of ASP containing 10 mg iron. The capsule was consumed with the test meal and serum iron was measured every 30 min for 4 hours. | Dietary Supplement: Ferrous sulfate<br>* The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.<br>* Other names: ASP (20 mg);|
| Experimental: ASP Fe (20 mg)<br>ASP (20 mg Fe): Each participant was given a one time oral dose ASP containing of 20 mg iron The capsule was consumed with the test meal and serum iron was measured every 30 min for 4 hours. | Dietary Supplement: Ferrous sulfate<br>* The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.<br>* Other names: ASP (20 mg);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum iron | Area under the curve | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron deficiency anemia, Iron fortification, ferrous sulfate, aspergillus oryzae, iron supplementation, AUC