Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146608
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-07-11
Brief Title:
Heme and Non-heme Iron Intakes Gut Microbiota and Influence on Host Iron Absorption
Sponsor:
Cornell University
Organization:
Cornell University
Study Overview
Official Title:
Heme and Non-heme Iron Intakes Gut Microbiota and Influence on Host Iron Absorption
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FeMicrobiome
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
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 eg beef pork chicken fish and seafood Iron absorption will be measured by using an in vivo functional approach based on stable iron isotopes ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-67017-39059 | OTHER_GRANT | United States Department of Agriculture | None |