Clinical trial NCT03156712: Iron Absorption From Iron-enriched Aspergillus Oryzae
Official title: Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Absorption; Iron
Anemia, Iron Deficiency
Bioavailability
Serum Iron
Keywords: Anemia
Iron deficiency anemia
Iron fortification
ferrous sulfate
aspergillus oryzae
iron supplementation
AUC
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 17
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: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum iron
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
affiliation: Iowa State University
name: Manju B Reddy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: