NCT06146608 · Cornell University
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
(FeMicrobiome)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
The percent of non-heme iron absorption
Time frame: 2-week
Percent non-heme iron absorption will be determined by red blood cell iron incorporation of stable 57Fe
The concentrations of hemoglobin
Time frame: baseline
The concentrations of hemoglobin (d/dL)
The concentrations of ferritin
Time frame: baseline
The concentrations of ferritin (ug/L)
Serum transferrin receptor
Time frame: baseline
Serum transferrin receptor in mg/L
The hematocrit
Time frame: baseline
Blood hematocrit in %
Habitual dietary information
Time frame: baseline
Habitual dietary information will be obtained from Diet History Questionnaire III.
Dietary information on the day prior to iron dosing
Time frame: baseline
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 composition
Time frame: baseline
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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,
- 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
Where
- Ithaca, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2025 · Source of record for eligibility and locations