Iron Absorption From Iron-enriched Aspergillus Oryzae

Iron-deficiency Clinical Trial

— BIEFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156712
• Other study ID #: BIEFS
• Status: Completed
• Phase: N/A
• First received: May 15, 2017
• Last updated: May 16, 2017
• Start date: May 29, 2013
• Est. completion date: February 13, 2014

Study information

• Verified date: May 2017
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 13, 2014
• Est. primary completion date: November 20, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Ferrous 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.

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum iron	Area under the curve	12 hours