[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06146608":3,"trial-entities:NCT06146608":104,"trial-summary:NCT06146608":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":78,"locations":80,"central_contacts":97,"overall_officials":99,"references":102,"see_also_links":103},"NCT06146608","IRB0147198","Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption","RECRUITING","2026-01-14","2025-02","2025-02-24","2023-01-15","Cornell University","OTHER",false,"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.","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.",[18,19],"Anemia, Iron Deficiency","Iron Overload",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},120,"ESTIMATED",[],[29,33,37,40,43,46,49,52],{"measure":30,"description":31,"timeFrame":32},"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",{"measure":34,"description":35,"timeFrame":36},"The concentrations of hemoglobin","The concentrations of hemoglobin (d\u002FdL)","baseline",{"measure":38,"description":39,"timeFrame":36},"The concentrations of ferritin","The concentrations of ferritin (ug\u002FL)",{"measure":41,"description":42,"timeFrame":36},"Serum transferrin receptor","Serum transferrin receptor in mg\u002FL",{"measure":44,"description":45,"timeFrame":36},"The hematocrit","Blood hematocrit in %",{"measure":47,"description":48,"timeFrame":36},"Habitual dietary information","Habitual dietary information will be obtained from Diet History Questionnaire III.",{"measure":50,"description":51,"timeFrame":36},"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.",{"measure":53,"description":54,"timeFrame":36},"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.",[],"ALL","18 Years","40 Years",true,{"inclusion":61,"exclusion":69,"raw_text":77},[62,63,64,65,66,67,68],"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\u002Fm2.",[70,71,72,73,74,75,76],"BMI \\\u003C18 or \\> 27 kg\u002Fm2,","Age \\\u003C18 y or \\> 40y,","Smoking","Pregnancy, lactating","Have gastrointestinal disorders\u002Fmalabsorption diseases\u002Fhemoglobinopathies\u002Fdietary restrictions\u002Fsteroid use\u002F 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","Inclusion Criteria:\n\n* Healthy adults\n* Age between 18- 40y\n* Non-smoking\n* Not currently taking vitamin, mineral, prebiotic, and probiotic supplements.\n* Females: premenopausal and not pregnant or lactating\n* No preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis)\n* Body mass index (BMI) between 18 - 27 kg\u002Fm2.\n\nExclusion Criteria:\n\n* BMI \\\u003C18 or \\> 27 kg\u002Fm2,\n* Age \\\u003C18 y or \\> 40y,\n* Smoking\n* Pregnancy, lactating\n* Have gastrointestinal disorders\u002Fmalabsorption diseases\u002Fhemoglobinopathies\u002Fdietary restrictions\u002Fsteroid use\u002F medication use of medications known to impact iron status, iron utilization or inflammatory status\n* Currently take vitamin, mineral, prebiotic, and probiotic supplements.\n* Recently received antibiotic treatment",[79],"ADULT",[81],{"facility":12,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":94},"Ithaca","New York","14853","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Kimberly O O'Brien, PhD","CONTACT","607-255-3743","koo4@cornell.edu",{"name":88,"role":93},"PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},42.44063,-76.49661,[98],{"name":88,"role":89,"phone":90,"email":91},[100],{"name":101,"affiliation":12,"role":93},"KIMBERLY ORA OBRIEN, PhD",[],[],{"nct_id":4,"conditions":105,"biomarkers":108},[106,107,19],"Anemia","Iron Deficiency",[],{"nct_id":4,"found":59,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an observational study planning to enroll 120 healthy adults to understand the relationship between diet, gut bacteria, and iron absorption.","completed","FeMicrobiome Study: Diet, Gut Bacteria, and Iron Absorption","This observational study, called FeMicrobiome, is looking at how the iron you eat, both from animal products (heme iron) and plant\u002Fanimal sources (non-heme iron), affects the bacteria in your gut and how well your body absorbs iron. Researchers want to understand if your diet changes your gut bacteria, and if that then changes how much iron your body takes in. They will measure the percentage of non-heme iron absorbed after two weeks, and check hemoglobin (a protein in red blood cells that carries oxygen) and ferritin (a protein that stores iron) levels at the start. They plan to enroll 120 healthy adults, aged 18-40, who are non-smokers and not taking certain supplements. Females must be premenopausal and not pregnant or breastfeeding. The study is currently unclear on its recruitment status.","Iron absorption will be measured at 2 weeks. Hemoglobin and ferritin concentrations are measured at baseline.",130,"Iron absorption will be measured using a special iron isotope. Hemoglobin and ferritin levels will be checked at the beginning of the study.","Not stated in the trial record.",[],"v2"]