Clinical trial NCT03586245: Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology
Official title: Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Absorption
Keywords: Iron Bioavailability
Iron Fortification
ferrous sulfate
ferric pyrophosphate
aspergillus oryzae
stable isotope
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Fractional Iron absorption of FePP, FeS)4 and ASP
timeFrame: Whole blood collected 14 days following isotope consumption to allow for enrichment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Iowa State University
name: Manju B Reddy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bries AE, Hurrell RF, Reddy MB. Iron Absorption from Bouillon Fortified with Iron-Enriched Aspergillus oryzae Is Higher Than That Fortified with Ferric Pyrophosphate in Young Women. J Nutr. 2020 May 1;150(5):1109-1115. doi: 10.1093/jn/nxaa035.