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Completed

NCT Number: NCT03586245

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferric pyrophosphate

Dietary Supplement

57 Iron isotopically labeled FePP powder.

Aspiron

Dietary Supplement

58 Iron isotope intrinsically labeled Aspergillus oryzae.

Ferrous Sulfate

Dietary Supplement

57 Iron isotopically labeled FeSO4 powder.

Primary outcomes

  1. Percentage Fractional Iron absorption of FePP, FeS)4 and ASP

    Time frame: Whole blood collected 14 days following isotope consumption to allow for enrichment.

    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).

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2018
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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