Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology
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|ClinicalTrials.gov Identifier: NCT03586245|
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : July 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron Absorption||Dietary Supplement: Ferric pyrophosphate Dietary Supplement: Aspiron Dietary Supplement: Ferrous sulfate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|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.|
|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.|
|Official Title:||Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.|
|Actual Study Start Date :||October 28, 2016|
|Actual Primary Completion Date :||May 3, 2017|
|Actual Study Completion Date :||June 20, 2017|
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.
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.
The Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP.
Dietary Supplement: Aspiron
58 Iron isotope intrinsically labeled Aspergillus oryzae.
The FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. .
Dietary Supplement: Ferrous sulfate
57 Iron isotopically labeled FeSO4 powder.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586245
|Principal Investigator:||Manju B Reddy, PhD||Iowa State University|