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Iron Absorption From Iron-enriched Aspergillus Oryzae

Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03156712
Acronym
BIEFS
Enrollment
17
Registered
2017-05-17
Start date
2013-05-29
Completion date
2014-02-13
Last updated
2017-05-18

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

Conditions

Absorption; Iron, Anemia, Iron Deficiency, Bioavailability, Iron-deficiency, Serum Iron

Keywords

Anemia, Iron deficiency anemia, Iron fortification, ferrous sulfate, aspergillus oryzae, iron supplementation, AUC

Brief summary

Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.

Detailed description

In a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. Prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. Following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. After two weeks other treatments were administered to each participant. The serum iron response curves for each treatment were constructed and the area under the curve (AUC) was calculated with the change of serum iron from baseline.

Interventions

DIETARY_SUPPLEMENTFerrous sulfate

The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.

Sponsors

Iowa State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Both investigators and participants were blinded to the iron treatment in this double-blinded, crossover study. Three different iron supplements were given, whereby participants were either administered 10 mg FeSO4, 10 mg ASP Fe, or 20 mg ASP Fe.

Intervention model description

Double-blinded, cross-over experimental design, whereby subjects were randomly given three different iron supplements with a meal in three different visits. All three visits (iron treatments) were each separated by two weeks time.

Eligibility

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

Inclusion criteria

* Non-pregnant * Non-lactating * Non-smoker * Not taking medications * Not taking dietary supplements (vitamins or minerals) * No history of gastrointestinal conditions

Exclusion criteria

* Any history of gastrointestinal conditions * On medications that interfere with iron absorption * Unwilling to stop taking dietary supplements (vitamins or minerals) * Pregnant * Lactating * Smoker

Design outcomes

Primary

MeasureTime frameDescription
Serum iron12 hoursArea under the curve

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026