At a glance
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A Stable Isotope Study in Young Iron-depleted Thai Women to Evaluate the Bioavailability of an Oat Protein-based Iron Delivery System
In Brief
A clinical study evaluating 54Fe SO4, 57Fe Oat-1, and 4 other interventions for Bioavailability. Completed, enrolled 52 participants across 1 site.
Detailed Summary
In the current study, the OAT fibril - Fe SA (Fe-oat 1) and OAT fibril - Fe NaOH (Fe-oat 2) will both be studied in vivo, alone are oat fibril powder add iron supplement is soluble in water and oat fibril powder add iron supplement is soluble in water in a food matrix (acai puree and honey) to assess their promise as Fe food fortificants. This first in human study to bioavailability assessment and adverse effect of the OAT fibril - Fe SA (Fe-oat 1), OAT fibril - Fe NaOH (Fe-oat 2) and in a food matrix to assess their promise as Fe food fortificants. This study will be conducted with the following objectives. 1. To conduct a stable Fe isotope study to evaluate the bioavailability of OAT-Fe formulated using two reducing agents (Fe-oat 1 and Fe-oat-2) and compared to FeSO4. 2. To compare the performance of Fe-oat 1 and 2 in a food matrix containing Fe inhibitors, (acai puree and honey) in comparison to FeSO4 in a similar meal matrix.
Study Details
Timeline
Interventions
4 mg of iron as FeSO4 labelled with 4 mg of 54Fe
4 mg of iron as 0.46 g Fe-oat 1 (Oat fibrils, ascorbic acid reduced) labelled with 57Fe
4 mg of iron as 0.46 g Fe-Oat 2 (Fe-Oat with NaOH) labelled with 58Fe.
4 mg of iron as FeSO4 labelled with 4 mg of 54Fe given with 30 mL acai puree with honey.
4 mg of iron as 0.46 g Fe-oat 1 (Oat fibrils, ascorbic acid reduced) labelled with 57Fe given with 30 mL acai puree with honey.
4 mg of iron as 0.46 g Fe-Oat 2 (Fe-Oat with NaOH) labelled with 58Fe given with 30 mL acai puree with honey