Diet Modulation of Bacterial Sulfur and Bile Acid Metabolism and Colon Cancer Risk (NCT03550885) | Clinical Trial Compass
CompletedNot Applicable
Diet Modulation of Bacterial Sulfur and Bile Acid Metabolism and Colon Cancer Risk
United States15 participantsStarted 2018-08-01
Plain-language 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).
Who can participate
Age range45 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
Change in the mucosal abundance of bacterial genes associated with sulfur and bile acid metabolism
Timeframe: Baseline and post-diet (day 22) for each of the two 3-week diets
✕. 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.)