Assessment of Iron Absorption From Aspergillus Oryzae

NCT03156725 | Completed

• 1 other identifier: HIFS study
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Bioavailability

Keywords

Iron Bioavailability; hepcidin; ferritin; iron absorption; iron status

Outcome Measures

Primary Outcomes (1)

• iron absorption

  Isotope enrichment in the blood samples

  15 days

Secondary Outcomes (1)

• iron status

  15 days

Study Arms (2)

Ferrous Sulfate

EXPERIMENTAL

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

Aspiron

EXPERIMENTAL

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

Interventions

Ferrous Sulfate DRUG

Ferrous Sulfate

Aspiron DIETARY_SUPPLEMENT

Aspiron

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Lactating
• Smoker
• Anemic (hemoglobin \< 120 g/L)
• Has gastro-intestinal disease/condition that can affect absorption
• Allergic to any of the meal components

Sponsors & Collaborators

• Iowa State University: lead

MeSH Terms

Interventions

ferrous sulfate

Study Officials

• Manju B Reddy, PhD

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 17, 2017
• Study Start: May 19, 2014
• Primary Completion: September 14, 2014
• Study Completion: June 4, 2016
• Last Updated: May 17, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share