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Iron Absorption From Iron-enriched Aspergillus Oryzae (BIEFS)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferrous sulfate
Sponsored by
Iowa State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-deficiency focused on measuring Anemia, Iron deficiency anemia, Iron fortification, ferrous sulfate, aspergillus oryzae, iron supplementation, AUC

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Iowa State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

FeSO4

ASP Fe (10 mg)

ASP Fe (20 mg)

Arm Description

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 (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 (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.

Outcomes

Primary Outcome Measures

Serum iron
Area under the curve

Secondary Outcome Measures

Full Information

First Posted
May 15, 2017
Last Updated
May 16, 2017
Sponsor
Iowa State University
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1. Study Identification

Unique Protocol Identification Number
NCT03156712
Brief Title
Iron Absorption From Iron-enriched Aspergillus Oryzae
Acronym
BIEFS
Official Title
Serum Iron Increase With From Iron-enriched Aspergillus Compared to Ferrous Sulfate in Healthy Female Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 29, 2013 (Actual)
Primary Completion Date
November 20, 2013 (Actual)
Study Completion Date
February 13, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Absorption; Iron, Anemia, Iron Deficiency, Bioavailability, Serum Iron
Keywords
Anemia, Iron deficiency anemia, Iron fortification, ferrous sulfate, aspergillus oryzae, iron supplementation, AUC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FeSO4
Arm Type
Experimental
Arm Description
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.
Arm Title
ASP Fe (10 mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
ASP Fe (20 mg)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferrous sulfate
Other Intervention Name(s)
ASP (10 mg), ASP (20 mg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum iron
Description
Area under the curve
Time Frame
12 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manju B Reddy, Ph.D.
Organizational Affiliation
Iowa State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa State University
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011-2101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Publish a paper

Learn more about this trial

Iron Absorption From Iron-enriched Aspergillus Oryzae

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