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

NCT06146608 | Recruiting

• 2 other identifiers: IRB01471982023-67017-39059
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• The percent of non-heme iron absorption

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

  2-week

• The concentrations of hemoglobin

  The concentrations of hemoglobin (d/dL)

  baseline

• The concentrations of ferritin

  The concentrations of ferritin (ug/L)

  baseline

• Serum transferrin receptor

  Serum transferrin receptor in mg/L

  baseline

• The hematocrit

  Blood hematocrit in %

  baseline

• Habitual dietary information

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

  baseline

• 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.

  baseline

• 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.

  baseline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Cornell University

Ithaca, New York, 14853, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples and fecal DNA

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Overload

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• KIMBERLY ORA OBRIEN, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly O O'Brien, PhD

CONTACT

607-255-3743; koo4@cornell.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: November 24, 2023
• Study Start: January 15, 2023
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

US (1)