Assessment of Iron Absorption From Aspergillus Oryzae

Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate

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.

Study Overview

• Status: Completed
• Conditions: Iron Bioavailability
• Intervention / Treatment: Drug: Ferrous Sulfate; Dietary supplement: Aspiron

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Ferrous Sulfate
EXPERIMENTAL: 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.	Dietary supplement: Aspiron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iron absorption	Isotope enrichment in the blood samples	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iron status	hepcidin and ferritin	15 days

Collaborators and Investigators

• Sponsor: Iowa State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2014
• Primary Completion (ACTUAL): September 14, 2014
• Study Completion (ACTUAL): June 4, 2016

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: hepcidin; iron absorption; iron status; ferritin; Iron Bioavailability
• Other Study ID Numbers: HIFS study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publication in a journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No