ClinicalTrials.gg
Active, not recruitingNCT06146608FeMicrobiomeUpdated Oct 23, 2026

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

An observational study in Anemia, Iron Deficiency and Iron Overload, sponsored by Cornell University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Cornell University · Observational

Updated Oct 23, 2026Now Active, not recruitingPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The FeMicrobiome study will evaluate gut microbiome features and their relationships with dietary iron absorption in healthy adults. The investigators hypothesize that (1) the gut microbiota can be shaped by the heme and non-heme Fe content of the diet and that (2) this will influence individual variation in dietary Fe absorption.

Read the detailed description

Iron is an essential micronutrient ingested as either heme iron (from animal products) or non-heme iron (from both plant and animal sources). Humans have no regulatable means of eliminating absorbed iron, necessitating tight control of dietary iron absorption. Likewise, native microbes have evolved efficient iron sensing and utilization pathways to scavenge iron from the gastrointestinal environment, resulting in a competition for iron between the host and their microbiota. As growing numbers of Americans adopt plant-based diets, heme iron intakes are markedly reduced. This may shift the gut microbiome as some gut microbiota cannot independently synthesize heme and require host dietary heme sources to support their heme-dependent functions. Animal data have recently discovered that other gut microbiota respond to a low iron. To date, significant knowledge gaps exist on the interplay between dietary iron sources, native gut microbes, and iron utilization in humans. In the FeMicrobiome study, study investigators will recruit 120 adults who habitually ingest plant-based diets or habitually ingest diets containing animal protein (e.g., beef, pork, chicken, fish, and seafood). Iron absorption will be measured by using an in vivo, functional approach based on stable iron isotopes (i.e., 57Fe). Study participants will consume 57Fe (as ferrous sulfate) in the fasted state followed by two standardized meals. 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. A stool sample will be collected near the time of 57Fe consumption. DNA will be extracted from this stool sample and sequenced using a high-depth shotgun metagenomic approach.

02

Conditions studied

  • Anemia, Iron Deficiency
  • Iron Overload
03

In context

Anemia, Iron-Deficiency

600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

120 healthy adults who habitually consume plant-based diets or habitually consume diets containing animal protein

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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, use, substance abuse history, or taking medications known to influence iron homeostasis)
  • (BMI) between 18 - 27 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • \<18 or > 27 kg/m2,
  • Age \<18 y or > 40y,
  • Smoking
  • Pregnancy, lactating
  • Have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/ 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. The percent of non-heme iron absorption

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

    Time frame: 2-week

  2. The concentrations of hemoglobin

    The concentrations of hemoglobin (d/dL)

    Time frame: baseline

  3. The concentrations of ferritin

    The concentrations of ferritin (ug/L)

    Time frame: baseline

  4. Serum transferrin receptor

    Serum transferrin receptor in mg/L

    Time frame: baseline

  5. The hematocrit

    Blood hematocrit in %

    Time frame: baseline

  6. Habitual dietary information

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

    Time frame: baseline

  7. Dietary information on the day prior to iron dosing

    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.

    Time frame: baseline

  8. Gut microbiome composition

    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.

    Time frame: baseline

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 23, 2026
Primary completion
Jan 14, 2026→Jan 14, 2027
Oct 23, 2026
Study completion
Jan 14, 2026→Jan 14, 2027
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Recruiting→Active, not recruiting
    Primary completion Jan 14, 2026→Jan 14, 2027
    Study completion Jan 14, 2026→Jan 14, 2027
    + 6 other changes: identifiers, verification date, oversight details, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06146608
Lead sponsor
Cornell University
Responsible party
Sponsor
First posted
Nov 24, 2023
Start date
Jan 15, 2023
Primary completion
Jan 14, 2027 (estimated)
Completion
Jan 14, 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

KIMBERLY ORA OBRIEN, PhD
principal investigator · Cornell University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion