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NCT03548948 · ClinicalTrials.gov registry record · NA
Obesity, Iron Regulation and Colorectal Cancer Risk
A NA study of Obesity and Diet Modification, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03548948 is a NA study of Obesity and Diet Modification that has completed, run by University of Illinois at Chicago. The registered enrollment target is 17 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03548948, a NA study of Obesity and Diet Modification, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Unlike the systemic compartment, the intestinal lumen lacks an efficient system to regulate iron. In conditions when dietary iron malabsorption and intestinal inflammation co-exist, greater luminal iron is associated with increased intestinal inflammation and a shift in the gut microbiota to more pro-inflammatory strains. However, treatments designed to reduce luminal, including diet restriction and chelation, are associated with lower intestinal inflammation and the colonization of protective gut microbes. Obesity is associated with inflammation-induced, hepcidin-mediated, iron metabolism dysfunction characterized by iron deficiency and dietary iron malabsorption. Obesity is also linked to intestinal inflammation. Currently, there is a fundamental gap in understanding how altered iron metabolism impacts CRC risk in obesity. The investigator's objective is to conduct a crossover controlled feeding trial of: 1) a "Typical American" diet with "high" heme/non-heme iron", 2) a "Typical American" diet with "low" iron, and 3) a Mediterranean diet with "high" non heme iron and examine effects on colonic and systemic inflammation and the gut microbiome.
Conditions Studied
Interventions
- OTHER High heme iron diet
- OTHER Low iron diet
- OTHER Plant-based high non-heme iron diet
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-07-15 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03548948
The ClinicalTrials.gov registry entry for NCT03548948 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which High heme iron diet is the first listed.
NCT03548948 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03548948 about?
NCT03548948 is a clinical study titled "Obesity, Iron Regulation and Colorectal Cancer Risk". Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Unlike the...
What is the current status of trial NCT03548948?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2015-07-15. Estimated completion is 2019-06-30.
What conditions does trial NCT03548948 study?
This clinical trial studies the following conditions: Obesity, Diet Modification, Iron Malabsorption, Colon Inflammation.
What interventions are being tested in trial NCT03548948?
The interventions under investigation include: High heme iron diet (OTHER), Low iron diet (OTHER), Plant-based high non-heme iron diet (OTHER).
Who is sponsoring clinical trial NCT03548948?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03548948 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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