Assessment of Iron Absorption From Aspergillus Oryzae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-19

Study Completion Date

2016-06-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Subjects were two meals on two consecutive days with the stable isotopes.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

When 57Fe was added to a meal an empy capsule was consumed by the subjects. 58Fe and natutal abundace iron associated with A. oryzae was consumed in capsule form.

Study Groups

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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.

Group Type EXPERIMENTAL

Ferrous Sulfate

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Aspiron

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ferrous Sulfate

Intervention Type DRUG

Aspiron

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes