Recruiting

Gut Microbiota

Sponsor:

Cornell University

Code:

NCT06146608

Conditions

Anemia, Iron Deficiency

Iron Overload

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Anemia, Iron Deficiency

Iron Overload

Study ID

NCT06146608

Start date

Jan 15, 2023

Status verified date

Feb, 2025

Completion date

Jan 14, 2026

Anticipated

Primary completion date

Jan 14, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The percent of non-heme iron absorption [ Time Frame: 2-week ]
  • The concentrations of hemoglobin [ Time Frame: baseline ]
  • The concentrations of ferritin [ Time Frame: baseline ]
  • Serum transferrin receptor [ Time Frame: baseline ]
  • The hematocrit [ Time Frame: baseline ]
  • Habitual dietary information [ Time Frame: baseline ]
  • Dietary information on the day prior to iron dosing [ Time Frame: baseline ]
  • Gut microbiome composition [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Kimberly O O'Brien, PhD

607-255-3743koo4@cornell.edu

Locations

Cornell University

Recruiting

Ithaca, New York, United States, 14853

Contacts

Kimberly O O'Brien, PhD

607-255-3743koo4@cornell.edu

Principal Investigator:

Kimberly O O'Brien, PhD

More Information

Sponsor

Cornell University

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cornell University on 2025-02-24.