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

Not Applicable

Completed

• Conditions: Iron Absorption
• Interventions: Dietary Supplement: Ferric pyrophosphate; Dietary Supplement: Aspiron; Dietary Supplement: Ferrous sulfate

• Registration Number: NCT03586245
• Lead Sponsor: Iowa State University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-10-28
• Primary Completion: 2017-05-03
• Study Completion: 2017-06-20
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-13
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ferric pyrophosphate	Ferric pyrophosphate	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.
Aspiron	Aspiron	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
Ferrous sulfate	Ferrous sulfate	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

Primary Outcome Measures

Name	Time	Method
Percentage Fractional Iron absorption of FePP, FeS)4 and ASP	Whole blood collected 14 days following isotope consumption to allow for enrichment.	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).