Clinical trial NCT04198545: Ethnic Differences in Iron Absorption (FeGenes)
Official title: Ethnic Differences in Iron Absorption
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anemia, Iron Deficiency
Iron Overload
Keywords: Iron absorption
Genetics
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
First posted: 2019-12-13
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults from Ithaca and Rochester, NY

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percent of non-heme iron absorption
timeFrame: 2-week
measure: The concentrations of iron and micronutrient status indicators
timeFrame: baseline and two-weeks post dosing
measure: Genetic ancestry and characterization of iron-related genotypes
timeFrame: baseline
measure: Habitual dietary information
timeFrame: baseline
measure: Dietary information on the study day
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Cornell University
name: Kimberly O O'Brien
role: PRINCIPAL_INVESTIGATOR
References: