Ethnic Differences in Iron Absorption (FeGenes)

NCT04198545 | Active Not Recruiting

• 2 other identifiers: IRB # 1904008754R01DK122216
• Study Type: observational
• Target: 515
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anemia, Iron Deficiency; Iron Overload

Keywords

Iron absorption; Genetics

Outcome Measures

Primary Outcomes (5)

• The percent of non-heme iron absorption

  The percent of non-heme iron absorption will be determined by red blood cell iron incorporation of stable 57Fe

  2-week

• The concentrations of iron and micronutrient status indicators

  The concentrations or serum folate, B12, hemoglobin, hematocrit, transferrin receptor, hepcidin, erythropoietin, erythroferrone, ferritin, interleukin-6, and c-reactive protein

  baseline and two-weeks post dosing

• Genetic ancestry and characterization of iron-related genotypes

  The DNA will be extracted from whole blood samples and each participant will have genetic ancestry and genotyping evaluated using the Illumina Global Diversity Array-8.

  baseline

• Habitual dietary information

  Habitual dietary information will be obtained from Diet History Questionnaire III .

  baseline

• Dietary information on the study day

  Detailed dietary information about all foods and beverages consumed on the study day will be obtained from the Automated Self-Administered 24-Hour Dietary Assessment Tool.

  baseline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults from Ithaca and Rochester, NY

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Cornell University

Ithaca, New York, 14853, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (4)

• 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.

  PMID: 40471375 DERIVED

• 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.

  PMID: 39909711 DERIVED

• 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.

  PMID: 39909710 DERIVED

• 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.

  PMID: 39909709 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and DNA samples will be collected.

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Overload

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kimberly O O'Brien

  Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: August 1, 2019
• Primary Completion: October 16, 2023
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)