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

NCT ID: NCT03586245

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2017-06-20

Brief 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.

Detailed 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.

Conditions

Iron Absorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ferric pyrophosphate

Study I group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds.

• 57FePP (95.8%) 3.49 mg
• Aspergillus oryzae (unenriched) 0.025 mg
• FePP natural abundance 0.685 mg.

Subjects received iron fortificants in a meal composed of zucchini, cabbage, carrot (42g each), onion (24g), corn oil (6.3 g), jasmine rice (75g dw), and flavored granulated chicken bouillon (6.6g). All meals were consumed in a fasted state with nothing to eat or drink (besides water) for 3 hours following consumption.

Group Type: ACTIVE_COMPARATOR

Ferric pyrophosphate

Intervention Type: DIETARY_SUPPLEMENT

57 Iron isotopically labeled FePP powder.

Aspiron

The Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP.

• ASP-p (8% Fe; natural abundance) 3.516 mg
• 58ASP-p (5% Fe; 99.5% enrichment) 0.68 mg
• 4.2 total mg of Fe

Group Type: EXPERIMENTAL

Aspiron

Intervention Type: DIETARY_SUPPLEMENT

58 Iron isotope intrinsically labeled Aspergillus oryzae.

Ferrous sulfate

The FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. .

• Aspergillus oryzae (unenriched) 0.027 mg
• 57FeSO4 (95.4%) 3.18 mg
• 4.2 total mg of Fe

Group Type: OTHER

Ferrous sulfate

Intervention Type: DIETARY_SUPPLEMENT

57 Iron isotopically labeled FeSO4 powder.

Interventions

Ferric pyrophosphate

57 Iron isotopically labeled FePP powder.

Intervention Type: DIETARY_SUPPLEMENT

Aspiron

58 Iron isotope intrinsically labeled Aspergillus oryzae.

Intervention Type: DIETARY_SUPPLEMENT

Ferrous sulfate

57 Iron isotopically labeled FeSO4 powder.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Iowa State University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Manju B. Reddy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manju B Reddy, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa State University

References

Bries AE, Hurrell RF, Reddy MB. Iron Absorption from Bouillon Fortified with Iron-Enriched Aspergillus oryzae Is Higher Than That Fortified with Ferric Pyrophosphate in Young Women. J Nutr. 2020 May 1;150(5):1109-1115. doi: 10.1093/jn/nxaa035.

Reference Type: DERIVED

PMID: 32073619 (View on PubMed)

Other Identifiers

ASP Study

Identifier Type: -

Identifier Source: org_study_id