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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03586245
Enrollment
35
Registered
2018-07-13
Start date
2016-10-28
Completion date
2017-06-20
Last updated
2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Absorption

Keywords

Iron Bioavailability, Iron Fortification, ferrous sulfate, ferric pyrophosphate, aspergillus oryzae, stable isotope

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.

Interventions

DIETARY_SUPPLEMENTFerric pyrophosphate

57 Iron isotopically labeled FePP powder.

DIETARY_SUPPLEMENTAspiron

58 Iron isotope intrinsically labeled Aspergillus oryzae.

DIETARY_SUPPLEMENTFerrous sulfate

57 Iron isotopically labeled FeSO4 powder.

Sponsors

Iowa State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

All stable isotopes (FePP, ASP, FeSO4) were all individually added to test meal and mixed thoroughly by investigators. Participants were brought the meal to consume, unknowingly of which respective treatment they were receiving.

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage Fractional Iron absorption of FePP, FeS)4 and ASPWhole 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026