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FeMicrobiome Study: Diet, Gut Bacteria, and Iron Absorption

This observational study, called FeMicrobiome, is looking at how the iron you eat, both from animal products (heme iron) and plant/animal sources (non-heme iron), affects the bacteria in your gut and how well your body absorbs iron. Researchers want to understand if your diet changes your gut bacteria, and if that then changes how much iron your body takes in. They will measure the percentage of non-heme iron absorbed after two weeks, and check hemoglobin (a protein in red blood cells that carries oxygen) and ferritin (a protein that stores iron) levels at the start. They plan to enroll 120 healthy adults, aged 18-40, who are non-smokers and not taking certain supplements. Females must be premenopausal and not pregnant or breastfeeding. The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to enroll 120 healthy adults to understand the relationship between diet, gut bacteria, and iron absorption.
What's involved
Iron absorption will be measured using a special iron isotope. Hemoglobin and ferritin levels will be checked at the beginning of the study.
Compensation
Not stated in the trial record.
Follow-up
Iron absorption will be measured at 2 weeks. Hemoglobin and ferritin concentrations are measured at baseline.

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NCT06146608

Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption

Recruiting
Not specifiedAges 18–40Observational
Cornell University
~120 participants
Updated 2025-02-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percent of non-heme iron absorption
Measured over 2-week
+7 more outcomes measured

Conditions

Anemia, Iron Deficiency
Iron Overload

Explore related trials

AnemiaIron DeficiencyIron Overload

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • KIMBERLY ORA OBRIEN, PhD · PRINCIPAL_INVESTIGATOR · Cornell University

Who to contact

Kimberly O O'Brien, PhD
[email protected]
607-255-3743
Email the study team

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Eligibility criteria

Inclusion

Healthy adults
Age between 18- 40y
Non-smoking
Not currently taking vitamin, mineral, prebiotic, and probiotic 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 - 27 kg/m2.

Exclusion

BMI \<18 or \> 27 kg/m2,
Age \<18 y or \> 40y,
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
Currently take vitamin, mineral, prebiotic, and probiotic supplements.
Recently received antibiotic treatment

What this trial measures

  • The percent of non-heme iron absorption2-week

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

  • The concentrations of hemoglobinbaseline

    The concentrations of hemoglobin (d/dL)

  • The concentrations of ferritinbaseline

    The concentrations of ferritin (ug/L)

  • Serum transferrin receptorbaseline

    Serum transferrin receptor in mg/L

  • The hematocritbaseline

    Blood hematocrit in %

  • Habitual dietary informationbaseline

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

  • Dietary information on the day prior to iron dosingbaseline

    Detailed dietary information about all foods and beverages consumed on the day prior to iron dosing will be obtained from the Automated Self-Administered 24-Hour Dietary Assessment Tool. Total iron intake will be presented as a proportion of the daily iron requirement. Total heme and non-heme iron intakes will be quantified.

  • Gut microbiome compositionbaseline

    Shotgun metagenomic sequencing will be performed to assess the gut microbiome compositions and gene functional features in a stool sample collected within one day before or after iron dosing.