Diet Modulation of Bacterial Sulfur and Bile Acid Metabolism and Colon Cancer Risk
Completed · Not applicable
Conditions studied: Colorectal Cancer
In brief
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).
Key facts
- Study ID
- NCT03550885
- Run by
- University of Illinois at Chicago
- People needed
- 15
- Starts
- 2018-08-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2026-04-06
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult African American;
- Obese (defined as BMI 30 - < 50 kg/m2);
- Age between 45 - 75 years old;
- Patients with an increased risk for CRC, defined as 3 or more adenomatous polyps or adenomatous polyp > 1cm within 5-yrs of enrollment;
- An elevated C-reactive protein (CRP) (defined as > 3 mg/l)
- Participants must be in good general health, not expecting major lifestyle changes in the next 6 months and willing to maintain their current activity level throughout the duration of the study.
- Women only: Post-menopausal (natural or surgical) defined as no menstruation in the past 6 months
You may not qualify if…
- BMI < 30 or > 50 kg/m2 (for those interested and eligible, verify BMI by measuring weight and height, complete the screening consent form before assessing these measures)
- Weight > 450 lbs. (max weight for the body composition scanner)
- Race other than African American
- Women only: at least one menstrual period in the past 6 months
- Current malignancy except non-melanoma skin cancer that has been removed
- Current gastrointestinal (GI) illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.)
- Chronic liver or kidney disease (elevated liver tests >3 times normal or creatinine above 2.0 mg/dl)
- History of cardiac disease (such as admission for congestive heart failure within the past 5 years, or being on anticoagulants for heart disease, or having an ejection fraction <25%, etc.)
- Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc)
- Alcoholism or illicit drug use
- Antibiotic use within the past 2 months
- Regularly taking medications that may interfere with normal digestion (such as acarbose, cholestyramine, Orlistat, aspirin doses that exceed 81mg/day or 325 mg every other day)
- Anticoagulant use or other factors that increase endoscopic risks
- Non-English speaking
- Pregnant or breast feeding
- Dietary supplement use including pre- or probiotics within the past month
- History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery
- Inflammatory or connective tissue diseases (such as lupus, scleroderma, rheumatoid arthritis, etc.)
- Prior perforation at colonoscopy or gastrointestinal bleeding due to biopsies of the colon 22. Therapeutic or vegetarian diet 23. Food allergy/aversions to any foods in included in the trial 24. Any medical condition, which, in the opinion of the investigator, could adversely affect the subject's participation in the trial, or affect the trial integrity
Where it is running
- Rush University Medical Center and University of Illinois at Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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