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

Sponsor

Iowa State University (Other)

Overall Status

Completed

CT.gov ID

NCT03586245

Collaborator

(none)

Enrollment

Arms

7.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Absorption	Dietary Supplement: Ferric pyrophosphate Dietary Supplement: Aspiron Dietary Supplement: Ferrous sulfate	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 28, 2016

Actual Primary Completion Date :

May 3, 2017

Actual Study Completion Date :

Jun 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Dietary Supplement: Ferric pyrophosphate 57 Iron isotopically labeled FePP powder.
Experimental: 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	Dietary Supplement: Aspiron 58 Iron isotope intrinsically labeled Aspergillus oryzae.
Other: 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	Dietary Supplement: Ferrous sulfate 57 Iron isotopically labeled FeSO4 powder.

Arm

Intervention/Treatment

Active Comparator: 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.

Dietary Supplement: Ferric pyrophosphate

57 Iron isotopically labeled FePP powder.

Experimental: 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

Dietary Supplement: Aspiron

58 Iron isotope intrinsically labeled Aspergillus oryzae.

Other: 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

Dietary Supplement: Ferrous sulfate

57 Iron isotopically labeled FeSO4 powder.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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