Ethnic Differences in Iron Absorption (FeGenes) (FeGenes)

Ethnic Differences in Iron Absorption

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Iron Overload; Anemia, Iron Deficiency

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 515

Contacts and Locations

• Study Contact: Name: Kimberly O O'Brien; Phone Number: 6072553743; Email: koo4@cornell.edu

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14853
      • Cornell University
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults from Ithaca and Rochester, NY

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Kimberly O O'Brien, Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Genetics; Iron absorption
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Iron Overload; Iron Deficiencies
• Other Study ID Numbers: IRB # 1904008754; R01DK122216 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No