Iron Absorption From Iron-enriched Aspergillus Oryzae

Not Applicable

Completed

• Conditions: Serum Iron; Iron-deficiency; Absorption; Iron; Anemia, Iron Deficiency; Bioavailability
• Interventions: Dietary Supplement: Ferrous sulfate

• Registration Number: NCT03156712
• Lead Sponsor: Iowa State University

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.

Study Timeline

• Study Start: 2013-05-29
• Primary Completion: 2013-11-20
• Study Completion: 2014-02-13
• Status Verified: 2017-05
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FeSO4	Ferrous sulfate	Ferrou sulfate: Each participant was given a one time oral dose of the 10 mg iron as ferrous sulfate with the test meal (described in study design) and serum iron was measured every 30 min for 4 hours.
ASP Fe (10 mg)	Ferrous sulfate	ASP (10 mg Fe): Each participants was given a one time oral dose of ASP containing 10 mg iron. The capsule was consumed with the test meal and serum iron was measured every 30 min for 4 hours.
ASP Fe (20 mg)	Ferrous sulfate	ASP (20 mg Fe): Each participant was given a one time oral dose ASP containing of 20 mg iron The capsule was consumed with the test meal and serum iron was measured every 30 min for 4 hours.

Primary Outcome Measures

Name	Time	Method
Serum iron	12 hours	Area under the curve

Trial Locations

Locations (1)

Iowa State University; 🇺🇸 Ames, Iowa, United States