Assessment of Iron Absorption From Aspergillus Oryzae

Not Applicable

Completed

• Conditions: Iron Bioavailability
• Interventions: Dietary Supplement: Aspiron; Drug: Ferrous Sulfate

• Registration Number: NCT03156725
• Lead Sponsor: Iowa State University

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.

Study Timeline

• Study Start: 2014-05-19
• Primary Completion: 2014-09-14
• Study Completion: 2016-06-04
• Status Verified: 2017-05
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspiron	Aspiron	The Asprion group was required to follow the same protocol as the 57Fe experimental group, with the exception of taking A. Oryzae containing (8 mg natural abundace Fe and 2 mg 58Fe. Meals composition was similar to ferrous sulafte group.
Ferrous Sulfate	Ferrous Sulfate	The ferrous sulfate group was required to consume a test containing ferrous sulfate (10 mg of 57Fe). Participants received a meal containing 17.6 g egg albumin, 45 g corn syrup solids, 17.5 g corn oil, 6 ml vanilla extract, and 100 ml of distilled water.

Primary Outcome Measures

Name	Time	Method
iron absorption	15 days	Isotope enrichment in the blood samples

Secondary Outcome Measures

Name	Time	Method
iron status	15 days	hepcidin and ferritin