Diet Modulation of Bacterial Sulfur and Bile Acid Metabolism and Colon Cancer Risk

NCT03550885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-06

No results posted yet for this study

Summary

Determine in the context of a controlled crossover diet-intervention trial the role of taurocholic acid metabolism by gut bacteria in African American subjects at elevated risk for colorectal cancer (CRC). Two isocaloric diets, an animal-based diet high in taurine and saturated fat (HT-HSAT) and a plant-based, low in taurine and low saturated fat (LT-LSAT) will be used to determine the extent to which the relationship between diet (independent variable) and mucosal markers of CRC risk including epithelial proliferation, oxidative stress, DNA damage, and primary and secondary bile acid pools and biomarkers of inflammation (dependent variables) is explained by the abundance of sulfidogenic bacteria and hydrogen sulfide (H2S) concentrations \&/or deoxycholic acid (DCA) and DCA-producing bacteria clostridium scindens (mediator variables).

Conditions

Interventions

OTHER

High taurine and saturated fat diet

This is a 3-week (21 day) isocaloric Western-type diet with all meals, snacks, beverages and condiments provided.

OTHER

Low in taurine and saturated fat diet

This is a 3-week (21 day) isocaloric largely plant-based diet with all meals, snacks, beverages and condiments provided.

Sponsors & Collaborators

  • Rush University Medical Center

    collaborator OTHER
  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Lisa Tussing-Humphreys, PhD, MS, RD · University of Illinois at Chicago

  • Ece Mutlu, MD, MS, MBA · Rush University Medical Center

  • H. Rex Gaskins, PhD · University of Illinois at Urbana-Champaign

  • Jason Ridlon, PhD · University of Illinois at Urbana-Champaign

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03550885 on ClinicalTrials.gov