Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology

Iron Absorption Clinical Trial

Official title:

Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03586245
• Other study ID #: ASP Study
• Status: Completed
• Phase: N/A
• Start date: October 28, 2016
• Est. completion date: June 20, 2017

Study information

• Verified date: August 2016
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to compare the iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.

Description:

Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally. Consequences such as decreased cognition, growth impairment, and morbidity and mortality arise from inadequate iron intake. Many technological challenges are presented in fortifying foods with iron, as inorganic iron salts are known to cause organoleptic problems in the food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability of the food is ideal, however most suitable iron fortificants contain low bioavailability. Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2 mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon. Participants were randomized to consume either meal A or B, followed by B or C. In study I, subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days following final isotope dosing, whole blood samples were collected and the fractional iron absorption of each iron fortificant containing labelled stable isotopes was measured via thermal ionization mass spectrometry with estimation of 80% incorporation into the hemoglobin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 20, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Suboptimal iron stores (Serum ferritin < 40 µg/L)

• BMI in range 18.5 - 24.9 kg/m2

• Willing to consumed meals containing iron supplement

• Willing to discontinue blood donation two weeks prior and during the study

• Willing to discontinue vitamin and mineral supplement use during the study

• Willing to provide a 15 ml blood for initial screening and 30 ml blood during the study (15 ml at each visit for 2 times in 24 days)

• Willing to attend 8 lab visits during the study

Exclusion Criteria:

• Pregnant

• Lactating

• Smoker

• Anemic (hemoglobin < 120 g/L)

• Has gastrointestinal disease/condition that can affect absorption

• Vegetarian

• Allergic to corn, wheat, soybean nor fungal supplements

Related Conditions & MeSH terms

• Iron Absorption

Intervention

Dietary Supplement:
• Ferric pyrophosphate
57 Iron isotopically labeled FePP powder.
• Aspiron
58 Iron isotope intrinsically labeled Aspergillus oryzae.
• Ferrous sulfate
57 Iron isotopically labeled FeSO4 powder.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Fractional Iron absorption of FePP, FeS)4 and ASP	Isotope enrichment in the whole blood samples after 14 days of feeding the meals assuming 80% incorporation of iron into the hemoglobin. Circulating iron was calculated from blood volume, height (cm), weight (kg) and hemoglobin (g/dL).	Whole blood collected 14 days following isotope consumption to allow for enrichment.