NCT03586245

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Iowa State University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Absorption

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ferric pyrophosphate	57 Iron isotopically labeled FePP powder.
DIETARY_SUPPLEMENT	Aspiron	58 Iron isotope intrinsically labeled Aspergillus oryzae.
DIETARY_SUPPLEMENT	Ferrous sulfate	57 Iron isotopically labeled FeSO4 powder.

Timeline

• Start date: 2016-10-28
• Primary completion: 2017-05-03
• Completion: 2017-06-20
• First posted: 2018-07-13
• Last updated: 2018-07-23