Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology

Study Overview
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Brief Summary
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The objective of this study was to compare the iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.

Detailed Description
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Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally. Consequences such as decreased cognition, growth impairment, and morbidity and mortality arise from inadequate iron intake. Many technological challenges are presented in fortifying foods with iron, as inorganic iron salts are known to cause organoleptic problems in the food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability of the food is ideal, however most suitable iron fortificants contain low bioavailability. Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2 mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon. Participants were randomized to consume either meal A or B, followed by B or C. In study I, subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days following final isotope dosing, whole blood samples were collected and the fractional iron absorption of each iron fortificant containing labelled stable isotopes was measured via thermal ionization mass spectrometry with estimation of 80% incorporation into the hemoglobin.

Official Title
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Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.

Conditions
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Iron Absorption

Intervention / Treatment
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* Dietary Supplement: Ferric pyrophosphate
* Dietary Supplement: Aspiron
* Dietary Supplement: Ferrous sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suboptimal iron stores (Serum ferritin < 40 µg/L) BMI in range 18.5 - 24.9 kg/m2 Willing to consumed meals containing iron supplement Willing to discontinue blood donation two weeks prior and during the study Willing to discontinue vitamin and mineral supplement use during the study Willing to provide a 15 ml blood for initial screening and 30 ml blood during the study (15 ml at each visit for 2 times in 24 days) Willing to attend 8 lab visits during the study Exclusion Criteria: Pregnant Lactating Smoker Anemic (hemoglobin < 120 g/L) Has gastrointestinal disease/condition that can affect absorption Vegetarian Allergic to corn, wheat, soybean nor fungal supplements

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: Subjects consumed two stable isotopes (57Fe and 58Fe). Study I, three consecutive days of meal A followed by crossover of three days meal B were consumed. Study II was a crossover between meal B and meal C.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferric pyrophosphate<br>Study I group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. 57FePP (95.8%) 3.49 mg Aspergillus oryzae (unenriched) 0.025 mg FePP natural abundance 0.685 mg. Subjects received iron fortificants in a meal composed of zucchini, cabbage, carrot (42g each), onion (24g), corn oil (6.3 g), jasmine rice (75g dw), and flavored granulated chicken bouillon (6.6g). All meals were consumed in a fasted state with nothing to eat or drink (besides water) for 3 hours following consumption. | Dietary Supplement: Ferric pyrophosphate<br>* 57 Iron isotopically labeled FePP powder.<br>|
| Experimental: Aspiron<br>The Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP. ASP-p (8% Fe; natural abundance) 3.516 mg 58ASP-p (5% Fe; 99.5% enrichment) 0.68 mg 4.2 total mg of Fe | Dietary Supplement: Aspiron<br>* 58 Iron isotope intrinsically labeled Aspergillus oryzae.<br>|
| Other: Ferrous sulfate<br>The FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. . Aspergillus oryzae (unenriched) 0.027 mg 57FeSO4 (95.4%) 3.18 mg 4.2 total mg of Fe | Dietary Supplement: Ferrous sulfate<br>* 57 Iron isotopically labeled FeSO4 powder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Fractional Iron absorption of FePP, FeS)4 and ASP | Isotope enrichment in the whole blood samples after 14 days of feeding the meals assuming 80% incorporation of iron into the hemoglobin. Circulating iron was calculated from blood volume, height (cm), weight (kg) and hemoglobin (g/dL). | Whole blood collected 14 days following isotope consumption to allow for enrichment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron Bioavailability, Iron Fortification, ferrous sulfate, ferric pyrophosphate, aspergillus oryzae, stable isotope