A Stable Isotope Study to Evaluate the Bioavailability of an Oat Protein-based Iron Delivery System

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.

Conditions

• Bioavailability

Interventions

OTHER

54Fe SO4

4 mg of iron as FeSO4 labelled with 4 mg of 54Fe

OTHER

57Fe Oat-1

4 mg of iron as 0.46 g Fe-oat 1 (Oat fibrils, ascorbic acid reduced) labelled with 57Fe

OTHER

58Fe Oat-2

4 mg of iron as 0.46 g Fe-Oat 2 (Fe-Oat with NaOH) labelled with 58Fe.

OTHER

54 FeSO4 + Acai puree with honey

4 mg of iron as FeSO4 labelled with 4 mg of 54Fe given with 30 mL acai puree with honey.

OTHER

57Fe Oat-1 + 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.

OTHER

58Fe Oat-2 + 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

Sponsors & Collaborators

• Mahidol University

  collaborator OTHER

• Swiss Federal Institute of Technology

  collaborator OTHER

• The Rainforest Company

  lead INDUSTRY

Principal Investigators

• Sueppong Gowachirapant · Mahidol University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-04-03

Primary Completion

2024-01-31

Completion

2024-02-29

Countries

• Thailand

Study Locations