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NCT05826899
A Stable Isotope Study to Evaluate the Bioavailability of an Oat Protein-based Iron Delivery System
NA trial testing 54Fe SO4 in Bioavailability in 52 participants. Completed in 29 February 2024.
31 January 2024
Quick facts
| Lead sponsor | The Rainforest Company |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 52 |
| Start date | 3 April 2023 |
| Primary completion | 31 January 2024 |
| Estimated completion | 29 February 2024 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- 54Fe SO4
- 57Fe Oat-1
- 58Fe Oat-2
- 54 FeSO4 + Acai puree with honey
- 57Fe Oat-1 + Acai puree with honey
- 58Fe Oat-2 + Acai puree with honey
Conditions studied
- Bioavailability — all drugs for Bioavailability →
Sponsor
The Rainforest Company
Who can join
Adults 18 to 45, female only, with Bioavailability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Oat protein nanofibril-iron hybrids offer a stable, high-absorption iron delivery platform for iron fortification.
Zhou J, Gowachirapant S, Zeder C, Wieczorek A, et al · · 2025 · cited 1× · PMID 41214296 · DOI 10.1038/s43016-025-01260-6
Verify or expand the search:
- PubMed search for NCT05826899
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT05774704 — Curcumin and Retinal Study · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05826899 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Rainforest Company
- Last refreshed: 11 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05826899.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing