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

Launched by UNIVERSITY OF ILLINOIS AT CHICAGO · Jun 6, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how different diets may affect the risk of colorectal cancer (CRC) in African American adults who are at higher risk for this disease. The researchers want to understand how gut bacteria process certain substances in food and how this relates to markers of cancer risk in the body. Participants will follow two different diets: one high in animal products and fat, and the other focused on plant-based foods. The goal is to see how these diets influence factors like inflammation and DNA damage, which are linked to cancer risk.

To join the study, participants must be African American adults aged 45 to 75 who are obese and have a higher risk of CRC, indicated by having multiple polyps or certain blood markers. Participants should be generally healthy and not planning to make major lifestyle changes during the study. Those who qualify can expect to follow the assigned diets, and their health will be monitored throughout the trial. It’s important to note that there are specific eligibility criteria, and some individuals with certain medical conditions or dietary restrictions may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult African American;
• • 2. Obese (defined as BMI 30 - \< 50 kg/m2);
• • 3. Age between 45 - 75 years old;
• • 4. Patients with an increased risk for CRC, defined as 3 or more adenomatous polyps or adenomatous polyp \> 1cm within 5-yrs of enrollment;
• • 5. An elevated C-reactive protein (CRP) (defined as \> 3 mg/l)
• • 6. 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.
• • 7. Women only: Post-menopausal (natural or surgical) defined as no menstruation in the past 6 months
• Exclusion Criteria:
• • 1. 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)
• • 2. Weight \> 450 lbs. (max weight for the body composition scanner)
• • 3. Race other than African American
• • 4. Women only: at least one menstrual period in the past 6 months
• • 5. Current malignancy except non-melanoma skin cancer that has been removed
• • 6. Current gastrointestinal (GI) illness other than gastroesophageal reflux disease or hemorrhoids (such as celiac disease, inflammatory bowel disease, malabsorptive bariatric procedures, etc.)
• • 7. Chronic liver or kidney disease (elevated liver tests \>3 times normal or creatinine above 2.0 mg/dl)
• • 8. 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.)
• • 9. Positive genetic test for inherited polyposis syndromes (such as familial adenomatous polyps, hereditary non-polyposis colon cancer syndromes, etc)
• • 10. Alcoholism or illicit drug use
• • 11. Antibiotic use within the past 2 months
• • 12. 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)
• • 13. Anticoagulant use or other factors that increase endoscopic risks
• • 14. Non-English speaking
• • 15. Pregnant or breast feeding
• • 16. Dietary supplement use including pre- or probiotics within the past month
• • 17. History of intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery
• • 18. Inflammatory or connective tissue diseases (such as lupus, scleroderma, rheumatoid arthritis, etc.)
• • 21. 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