Ethnic Differences in Iron Absorption (FeGenes)

NCT ID: NCT04198545

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2025-12-31

Brief Summary

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This study aims to; 1) investigate population differences in iron absorption between East Asians and Northern Europeans; 2) assess population differences in hormonal and biochemical determinants of Fe absorption between East Asians and Northern Europeans; and 3) to investigate genetic contributions to Fe absorption, Fe status and Fe regulatory hormones between East Asians and Northern Europeans.

Detailed Description

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Detailed description:

This study will utilize a multidisciplinary approach to identify genetic variation in genes that control iron utilization in order to shed light on the genetic basis of population differences in iron status and disease susceptibility with a long-term goal of informing population-specific dietary iron intake recommendations to minimize the risk of chronic diseases. To evaluate iron utilization, we will employ an in vivo, functional approach using an oral stable iron isotope method. Each participant will have genetic ancestry and genotyping evaluated using the Illumina Global Diversity Array-8. Study participants (n=504, aged 18-50 y) will consume 57Fe (as ferrous sulfate) in the fasted state and will then ingest a standardized breakfast and lunch meal. Two weeks after iron dosing, a blood sample will be collected from each participant and the amount of 57Fe incorporated into red blood cells will be measured using magnetic sector thermal ionization mass spectrometry. This project will fundamentally advance our understanding of ethnic differences in nutrient metabolism and iron status. It will also provide information to assist with the long-term goal of reducing the public health burden of Fe-related diseases.

Conditions

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Anemia, Iron Deficiency Iron Overload

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adults
* Age between 18- 50y
* Non-smoking
* Not taking vitamin or mineral supplements.
* Females: premenopausal and not pregnant or lactating
* No preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)
* Body mass index (BMI) between 18 - 30 kg/m2.

Exclusion Criteria

* BMI \<18 or \> 30 kg/m2,
* Age \<18 y or \> 50y,
* Not of Northern European or East Asian ancestry
* Smoking
* Pregnancy, lactating
* Have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/steroid use/ medication use of medications known to impact iron status, iron utilization or inflammatory status
* Take vitamin and mineral supplementations
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly O O'Brien

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

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Cornell University

Ithaca, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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Park CY, Barad A, Xu Y, Bender E, Thomas AK, Haller CM, Gu Z, Pressman EK, O'Brien KO. Dietary intake in East Asian and Northern European participants from the FeGenes study. Eur J Nutr. 2025 Jun 5;64(5):205. doi: 10.1007/s00394-025-03730-w.

Reference Type DERIVED
PMID: 40471375 (View on PubMed)

Barad A, Xu Y, Bender E, Pressman EK, Gu Z, O'Brien KO. Differences in nonheme iron absorption between healthy adults of East Asian or Northern European ancestry from the Iron Genes in East Asian and Northern European Adults Study (FeGenes): A cross-sectional stable iron isotope study. Am J Clin Nutr. 2025 Feb;121(2):417-426. doi: 10.1016/j.ajcnut.2024.11.015.

Reference Type DERIVED
PMID: 39909711 (View on PubMed)

Barad A, Xu Y, Bender E, Pressman EK, Gu Z, O'Brien KO. Iron regulatory hormones and their associations with iron status biomarkers among healthy adults of East Asian or Northern European ancestry: A cross-sectional comparison from the Iron Genes in East Asian and Northern European Adults Study (FeGenes). Am J Clin Nutr. 2025 Feb;121(2):406-416. doi: 10.1016/j.ajcnut.2024.10.018.

Reference Type DERIVED
PMID: 39909710 (View on PubMed)

Barad A, Xu Y, Bender E, Kang W, Xu R, Gu Z, Pressman EK, O'Brien KO. Characterization of iron status biomarkers and hematological indices among young adults of East Asian or Northern European ancestry: A cross-sectional analysis from the Iron Genes in East Asian and Northern European Adults Study (FeGenes). Am J Clin Nutr. 2025 Feb;121(2):394-405. doi: 10.1016/j.ajcnut.2024.10.014.

Reference Type DERIVED
PMID: 39909709 (View on PubMed)

Other Identifiers

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R01DK122216

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB # 1904008754

Identifier Type: -

Identifier Source: org_study_id

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