Clinical trial NCT02197624: Genetic Variants and Iron Absorption
Official title: Metabolic Adaptation to Plant-based Diets in Asian Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Absorption
Keywords: Non-heme iron absorption; HFE
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women were eligible for the study if they met the following criteria: 1) non-pregnant and between the ages of 18\~35 y; 2) of East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore; 3) not taking any vitamin or mineral supplements for at least 1 month before the study and during the 2-week study interval; 4) no pre-existing medical problems including malabsorption, blood disorders, ulcers, joint diseases or asthma that might impact inflammation or Fe status; 5) not taking any prescribed medications known to affect iron homeostasis.

Brief summary: The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian women. The investigators hypothesize that the genetic variant could enhance iron status and iron absorption in Asian women.

Detailed description: To determine the HFE genotype of female Asian study volunteers, we collected venous blood samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT, and TT and used to assess possible differences in iron status as a function of genotype. To measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a blood sample was collected from each woman and the amount of non-heme (57Fe) iron incorporated into red blood cells was measured with magnetic sector thermal ionization mass spectrometry. Possible associations between iron status and iron absorption as a function of genotypes were explored. Data from this study will provide information that aims to improve human health by better understanding the iron requirements of individuals with different genetic background.

Eligibility criteria: Inclusion Criteria:

* non-pregnant and between the ages of 18\~35 y
* East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore

Exclusion Criteria:

* taking or planing to take any vitamin or mineral supplements during the study period
* pre-existing medical problems that might impact inflammation or Fe status, including malabsorption, blood disorders, ulcers, joint diseases and asthma
* taking any prescribed medications known to affect iron homeostasis

Primary outcomes:
measure: Genotype at SNP rs9366637
timeFrame: 2 weeks after the participant's visit to the laboratory
measure: Hemoglobin
timeFrame: Up to 2 days after the participant's visit to the laboratory
measure: Serum Ferritin
timeFrame: Up to 6 months after the participant's visit to the laboratory
measure: Serum transferrin receptor
timeFrame: Up to 6 months after the participant's visit to the laboratory
measure: Non-heme Iron absorption in women with 2 HFE genotypes
timeFrame: one month for screening with genotype then 2 weeks for iron absorption study
Secondary outcomes:
measure: Folate
timeFrame: Up to 6 months after the participant's visit to the laboratory
measure: Vitamin B-12
timeFrame: Up to 6 months after the participant's visit to the laboratory
measure: C-reactive protein
timeFrame: Up to 6 months after the participant's visit to the laboratory
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Human Metabolic Research Unit, Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Kimberly O'Brien, PhD
role: PRINCIPAL_INVESTIGATOR
References: