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Assessment of Iron Absorption From Aspergillus Oryzae

Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03156725
Enrollment
16
Registered
2017-05-17
Start date
2014-05-19
Completion date
2016-06-04
Last updated
2017-05-17

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

Conditions

Iron Bioavailability

Keywords

Iron Bioavailability, hepcidin, ferritin, iron absorption, iron status

Brief summary

The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.

Detailed description

Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value \<30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.

Interventions

DRUGFerrous Sulfate
DIETARY_SUPPLEMENTAspiron

Sponsors

Iowa State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

When 57Fe was added to a meal an empy capsule was consumed by the subjects. 58Fe and natutal abundace iron associated with A. oryzae was consumed in capsule form.

Intervention model description

Subjects were two meals on two consecutive days with the stable isotopes.

Eligibility

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

Inclusion criteria

* Marginal iron status (Serum ferritin \<30ug/L) * BMI in the range 18.5-24.9 kg/m2 * Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study * Willing to consume stable iron isotope labelled supplement * Willing to stop getting blood drawn 2 weeks prior to the study and during the study * Willing to give multiple blood samples at beginning and end of study

Exclusion criteria

* Pregnant * Lactating * Smoker * Anemic (hemoglobin \< 120 g/L) * Has gastro-intestinal disease/condition that can affect absorption * Allergic to any of the meal components

Design outcomes

Primary

MeasureTime frameDescription
iron absorption15 daysIsotope enrichment in the blood samples

Secondary

MeasureTime frameDescription
iron status15 dayshepcidin and ferritin

Outcome results

None listed

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