NCT05826899

Brief 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

April 11, 2024

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

April 9, 2023

Last Update Submit

April 10, 2024

Conditions

Bioavailability

Keywords

oat proteiniron-depleted womanstable isotope

Outcome Measures

Primary Outcomes (1)

  • Fractional absorption of iron (%)

    Fractional absorption of iron (%) from the iron supplements will be calculated based on the shift of the iron isotope ratios in the collected blood samples at least 14 days after the last administration of the isotopically labelled supplements.

    37 days

Secondary Outcomes (3)

  • Hemoglobin (g/dL)

    37 days

  • serum ferritin (ng/mL)

    37 days

  • c-reactive protein (mg/L)

    37 days

Study Arms (6)

oat protein-based iron delivery system1

ACTIVE COMPARATOR

Each subject will complete the six iron absorption studies in which they will receive supplemental iron doses of 4 mg iron from the six products: (i) Fe-oat 1 alone, (ii) Fe-oat 1 with 30 mL acai puree with honey, (iii) Fe-oat 2 alone, (iv) Fe-oat 2 with 30 mL acai puree with honey, (v) FeSO4 alone, (vi) FeSO4 with 30 mL acai puree and honey.

Other: 54Fe SO4Other: 57Fe Oat-1Other: 58Fe Oat-2Other: 54 FeSO4 + Acai puree with honeyOther: 57Fe Oat-1 + Acai puree with honeyOther: 58Fe Oat-2 + Acai puree with honey

oat protein-based iron delivery system2

ACTIVE COMPARATOR

Each subject will complete the six iron absorption studies in which they will receive supplemental iron doses of 4 mg iron from the six products: (i) Fe-oat 1 alone, (ii) Fe-oat 1 with 30 mL acai puree with honey, (iii) Fe-oat 2 alone, (iv) Fe-oat 2 with 30 mL acai puree with honey, (v) FeSO4 alone, (vi) FeSO4 with 30 mL acai puree and honey.

Other: 54Fe SO4Other: 57Fe Oat-1Other: 58Fe Oat-2Other: 54 FeSO4 + Acai puree with honeyOther: 57Fe Oat-1 + Acai puree with honeyOther: 58Fe Oat-2 + Acai puree with honey

oat protein-based iron delivery system3

ACTIVE COMPARATOR

Each subject will complete the six iron absorption studies in which they will receive supplemental iron doses of 4 mg iron from the six products: (i) Fe-oat 1 alone, (ii) Fe-oat 1 with 30 mL acai puree with honey, (iii) Fe-oat 2 alone, (iv) Fe-oat 2 with 30 mL acai puree with honey, (v) FeSO4 alone, (vi) FeSO4 with 30 mL acai puree and honey.

Other: 54Fe SO4Other: 57Fe Oat-1Other: 58Fe Oat-2Other: 54 FeSO4 + Acai puree with honeyOther: 57Fe Oat-1 + Acai puree with honeyOther: 58Fe Oat-2 + Acai puree with honey

oat protein-based iron delivery system4

ACTIVE COMPARATOR

Each subject will complete the six iron absorption studies in which they will receive supplemental iron doses of 4 mg iron from the six products: (i) Fe-oat 1 alone, (ii) Fe-oat 1 with 30 mL acai puree with honey, (iii) Fe-oat 2 alone, (iv) Fe-oat 2 with 30 mL acai puree with honey, (v) FeSO4 alone, (vi) FeSO4 with 30 mL acai puree and honey.

Other: 54Fe SO4Other: 57Fe Oat-1Other: 58Fe Oat-2Other: 54 FeSO4 + Acai puree with honeyOther: 57Fe Oat-1 + Acai puree with honeyOther: 58Fe Oat-2 + Acai puree with honey

oat protein-based iron delivery system5

ACTIVE COMPARATOR

Each subject will complete the six iron absorption studies in which they will receive supplemental iron doses of 4 mg iron from the six products: (i) Fe-oat 1 alone, (ii) Fe-oat 1 with 30 mL acai puree with honey, (iii) Fe-oat 2 alone, (iv) Fe-oat 2 with 30 mL acai puree with honey, (v) FeSO4 alone, (vi) FeSO4 with 30 mL acai puree and honey.

Other: 54Fe SO4Other: 57Fe Oat-1Other: 58Fe Oat-2Other: 54 FeSO4 + Acai puree with honeyOther: 57Fe Oat-1 + Acai puree with honeyOther: 58Fe Oat-2 + Acai puree with honey

oat protein-based iron delivery system6

ACTIVE COMPARATOR

Each subject will complete the six iron absorption studies in which they will receive supplemental iron doses of 4 mg iron from the six products: (i) Fe-oat 1 alone, (ii) Fe-oat 1 with 30 mL acai puree with honey, (iii) Fe-oat 2 alone, (iv) Fe-oat 2 with 30 mL acai puree with honey, (v) FeSO4 alone, (vi) FeSO4 with 30 mL acai puree and honey.

Other: 54Fe SO4Other: 57Fe Oat-1Other: 58Fe Oat-2Other: 54 FeSO4 + Acai puree with honeyOther: 57Fe Oat-1 + Acai puree with honeyOther: 58Fe Oat-2 + Acai puree with honey

Interventions

54Fe SO4OTHER

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

oat protein-based iron delivery system1oat protein-based iron delivery system2oat protein-based iron delivery system3oat protein-based iron delivery system4oat protein-based iron delivery system5oat protein-based iron delivery system6
57Fe Oat-1OTHER

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

oat protein-based iron delivery system1oat protein-based iron delivery system2oat protein-based iron delivery system3oat protein-based iron delivery system4oat protein-based iron delivery system5oat protein-based iron delivery system6
58Fe Oat-2OTHER

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

oat protein-based iron delivery system1oat protein-based iron delivery system2oat protein-based iron delivery system3oat protein-based iron delivery system4oat protein-based iron delivery system5oat protein-based iron delivery system6
54 FeSO4 + Acai puree with honeyOTHER

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

oat protein-based iron delivery system1oat protein-based iron delivery system2oat protein-based iron delivery system3oat protein-based iron delivery system4oat protein-based iron delivery system5oat protein-based iron delivery system6
57Fe Oat-1 + Acai puree with honeyOTHER

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.

oat protein-based iron delivery system1oat protein-based iron delivery system2oat protein-based iron delivery system3oat protein-based iron delivery system4oat protein-based iron delivery system5oat protein-based iron delivery system6
58Fe Oat-2 + Acai puree with honeyOTHER

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

oat protein-based iron delivery system1oat protein-based iron delivery system2oat protein-based iron delivery system3oat protein-based iron delivery system4oat protein-based iron delivery system5oat protein-based iron delivery system6

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female aged between 18-45 y old
  • serum ferritin 10-50 μg/L
  • hemoglobin ≥12g/dL
  • BMI 18.5-24.9 kg/m2
  • weight \<70 kg
  • signed informed consent
  • able to communicate in and comprehend Thai language

You may not qualify if:

  • anemia (Hb \<12 g/dL)
  • presence of thalassemia (with the exceptions of Hb E and alpha thal 1 trait)
  • inflammation (CRP \> 5 mg/L)
  • chronic digestive, renal and/or metabolic disease
  • chronic medications (except for oral contraceptives)
  • use of vitamin, mineral and pre- and/or probiotic supplements in the previous 2 weeks before study initiation and during the course of the study
  • blood transfusion, blood donation or significant blood loss over the past 4 months
  • difficulties with blood sampling
  • antibiotic treatment in the 4 weeks before study initiation
  • pregnancy (tested in serum at screening) or intention to become pregnant
  • lactation up to 6 weeks before study initiation
  • earlier participation in a study using stable isotopes or participation in any clinical study within the last 30 days
  • unable to comply with study protocol (e.g. not available on certain study appointment days or difficulties with blood withdrawal)
  • inability to understand the information sheet and the informed consent form due to cognitive or language reasons
  • smoking
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition, Institute of Nutrition Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (15)

  • Miller JL. Iron deficiency anemia: a common and curable disease. Cold Spring Harb Perspect Med. 2013 Jul 1;3(7):a011866. doi: 10.1101/cshperspect.a011866.

    PMID: 23613366BACKGROUND

  • Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.

    PMID: 25700159BACKGROUND

  • Allen L, De Benoist B, Dary O, Hurrell R. Guidelines on food fortification with micronutrients: JSTOR; 2006.

    BACKGROUND

  • Hurrell RF. Fortification: overcoming technical and practical barriers. J Nutr. 2002 Apr;132(4 Suppl):806S-12S. doi: 10.1093/jn/132.4.806S.

    PMID: 11925486BACKGROUND

  • Acosta E. Bioavailability of nanoparticles in nutrient and nutraceutical delivery. Current opinion in colloid & interface science. 2009;14(1):3-15.

    BACKGROUND

  • Hilty FM, Arnold M, Hilbe M, Teleki A, Knijnenburg JT, Ehrensperger F, Hurrell RF, Pratsinis SE, Langhans W, Zimmermann MB. Iron from nanocompounds containing iron and zinc is highly bioavailable in rats without tissue accumulation. Nat Nanotechnol. 2010 May;5(5):374-80. doi: 10.1038/nnano.2010.79. Epub 2010 Apr 25.

    PMID: 20418865BACKGROUND

  • Rohner F, Ernst FO, Arnold M, Hilbe M, Biebinger R, Ehrensperger F, Pratsinis SE, Langhans W, Hurrell RF, Zimmermann MB. Synthesis, characterization, and bioavailability in rats of ferric phosphate nanoparticles. J Nutr. 2007 Mar;137(3):614-9. doi: 10.1093/jn/137.3.614.

    PMID: 17311949BACKGROUND

  • Huber DL. Synthesis, properties, and applications of iron nanoparticles. Small. 2005 May;1(5):482-501. doi: 10.1002/smll.200500006.

    PMID: 17193474BACKGROUND

  • Shen Y, Posavec L, Bolisetty S, Hilty FM, Nystrom G, Kohlbrecher J, Hilbe M, Rossi A, Baumgartner J, Zimmermann MB, Mezzenga R. Amyloid fibril systems reduce, stabilize and deliver bioavailable nanosized iron. Nat Nanotechnol. 2017 Jul;12(7):642-647. doi: 10.1038/nnano.2017.58. Epub 2017 Apr 24.

    PMID: 28436960BACKGROUND

  • Baumgartner J, Winkler HC, Zandberg L, Tuntipopipat S, Mankong P, Bester C, Hilty F, Zeevaart JR, Gowachirapant S, Zimmermann MB. Iron from nanostructured ferric phosphate: absorption and biodistribution in mice and bioavailability in iron deficient anemic women. Sci Rep. 2022 Feb 18;12(1):2792. doi: 10.1038/s41598-022-06701-x.

    PMID: 35181698BACKGROUND

  • Zhou J, Li T, Peydayesh M, Usuelli M, Lutz-Bueno V, Teng J, Wang L, Mezzenga R. Oat Plant Amyloids for Sustainable Functional Materials. Adv Sci (Weinh). 2022 Feb;9(4):e2104445. doi: 10.1002/advs.202104445. Epub 2021 Dec 20.

    PMID: 34931493BACKGROUND

  • Cercamondi CI, Egli IM, Mitchikpe E, Tossou F, Zeder C, Hounhouigan JD, Hurrell RF. Total iron absorption by young women from iron-biofortified pearl millet composite meals is double that from regular millet meals but less than that from post-harvest iron-fortified millet meals. J Nutr. 2013 Sep;143(9):1376-82. doi: 10.3945/jn.113.176826. Epub 2013 Jul 24.

    PMID: 23884388BACKGROUND

  • BROWN E, HOPPER J Jr, HODGES JL Jr, BRADLEY B, WENNESLAND R, YAMAUCHI H. Red cell, plasma, and blood volume in the healthy women measured by radiochromium cell-labeling and hematocrit. J Clin Invest. 1962 Dec;41(12):2182-90. doi: 10.1172/JCI104677. No abstract available.

    PMID: 14015940BACKGROUND

  • International Nutritional Anemia Consultative Group (INACG) WHOW, United Nations Childrens Fund (UNICEF). Guidelines for the use of iron supplements to prevent and treat iron deficiency anemia. 1998.

    BACKGROUND

  • von Moos LM, Schneider M, Hilty FM, Hilbe M, Arnold M, Ziegler N, Mato DS, Winkler H, Tarik M, Ludwig C, Naegeli H, Langhans W, Zimmermann MB, Sturla SJ, Trantakis IA. Iron phosphate nanoparticles for food fortification: Biological effects in rats and human cell lines. Nanotoxicology. 2017 May;11(4):496-506. doi: 10.1080/17435390.2017.1314035. Epub 2017 Apr 20.

    PMID: 28368214BACKGROUND

MeSH Terms

Interventions

Honey

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Sueppong Gowachirapant

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2023

First Posted

April 24, 2023

Study Start

April 3, 2023

Primary Completion

January 31, 2024

Study Completion

February 29, 2024

Last Updated

April 11, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)