- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146608
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption (FeMicrobiome)
March 11, 2024 updated by: Cornell University
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kimberly O O'Brien, PhD
- Phone Number: 607-255-3743
- Email: koo4@cornell.edu
Study Locations
-
-
New York
-
Ithaca, New York, United States, 14853
- Recruiting
- Cornell University
-
Contact:
- Kimberly O O'Brien, PhD
- Phone Number: 607-255-3743
- Email: koo4@cornell.edu
-
Principal Investigator:
- Kimberly O O'Brien, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
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
Description
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,
- Not of Northern European or East Asian ancestry
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2-week
|
The concentrations of hemoglobin
Time Frame: baseline
|
The concentrations of hemoglobin (d/dL)
|
baseline
|
The concentrations of ferritin
Time Frame: baseline
|
The concentrations of ferritin (ug/L)
|
baseline
|
Serum transferrin receptor
Time Frame: baseline
|
Serum transferrin receptor in mg/L
|
baseline
|
The hematocrit
Time Frame: baseline
|
Blood hematocrit in %
|
baseline
|
Habitual dietary information
Time Frame: baseline
|
Habitual dietary information will be obtained from Diet History Questionnaire III.
|
baseline
|
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.
|
baseline
|
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.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: KIMBERLY ORA OBRIEN, PhD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2023
Primary Completion (Estimated)
January 14, 2026
Study Completion (Estimated)
January 14, 2026
Study Registration Dates
First Submitted
July 11, 2023
First Submitted That Met QC Criteria
November 21, 2023
First Posted (Actual)
November 24, 2023
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0147198
- 2023-67017-39059 (Other Grant/Funding Number: United States Department of Agriculture)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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