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

NCT03586245 | Completed

• 1 other identifier: ASP Study
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Absorption

Keywords

Iron Bioavailability; Iron Fortification; ferrous sulfate; ferric pyrophosphate; aspergillus oryzae; stable isotope

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Ferric pyrophosphate

ACTIVE COMPARATOR

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.

Dietary Supplement: Ferric pyrophosphate

Aspiron

EXPERIMENTAL

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

Dietary Supplement: Aspiron

Ferrous sulfate

OTHER

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

Dietary Supplement: Ferrous sulfate

Interventions

Ferric pyrophosphate DIETARY_SUPPLEMENT

57 Iron isotopically labeled FePP powder.

Ferric pyrophosphate

Aspiron DIETARY_SUPPLEMENT

58 Iron isotope intrinsically labeled Aspergillus oryzae.

Aspiron

Ferrous sulfate DIETARY_SUPPLEMENT

57 Iron isotopically labeled FeSO4 powder.

Ferrous sulfate

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Related Publications (1)

• 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.

  PMID: 32073619 DERIVED

MeSH Terms

Interventions

ferric pyrophosphate; 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: All stable isotopes (FePP, ASP, FeSO4) were all individually added to test meal and mixed thoroughly by investigators. Participants were brought the meal to consume, unknowingly of which respective treatment they were receiving.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects consumed two stable isotopes (57Fe and 58Fe). Study I, three consecutive days of meal A followed by crossover of three days meal B were consumed. Study II was a crossover between meal B and meal C.

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 13, 2018
• Study Start: October 28, 2016
• Primary Completion: May 3, 2017
• Study Completion: June 20, 2017
• Last Updated: July 23, 2018

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share