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Ethnic Differences in Iron Absorption (FeGenes)

Active, not recruiting
Conditions
Anemia, Iron Deficiency
Iron Overload
Registration Number
NCT04198545
Lead Sponsor
Cornell University
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
515
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Habitual dietary informationbaseline

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

The concentrations of iron and micronutrient status indicatorsbaseline and two-weeks post dosing

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

Genetic ancestry and characterization of iron-related genotypesbaseline

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.

Dietary information on the study daybaseline

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.

The percent of non-heme iron absorption2-week

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Cornell University

🇺🇸

Ithaca, New York, United States

University of Rochester

🇺🇸

Rochester, New York, United States

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