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

November 21, 2019

Overview

This diet-intervention trial focuses on African American subjects who are at higher risk for developing colorectal cancer (CRC). Two diets, one animal based and the other plant based (but both consisting of the same calories) will be used to determine the relationship between diet and mucosal markers of CRC risk. The study aims to determine why consumption of a high red meat and saturated fat diet imparts risk for CRC development and to demonstrate that risk factors are modifiable by diet. The focus is on taurine, an overlooked sulfur amino acid (SAA) that is abundant in red meat.

 

Study Information

This interventional clinical trial will involve participants partaking in two different experimental diets. There will be an estimated enrollment of 44 participants. The study began on August 1st 2018 and is predicted to be completed by August 2021.

 

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)
  • 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
  • Therapeutic or vegetarian diet
  • Food allergy/aversions to any foods in included in the trial
  • 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

 

Location

This study is taking place at Rush University Medical Center and University of Illinois at Chicago, Chicago, Illinois, United States, 60612. For further information please contact Lisa Tussing-Humphreys, PhD, MS, RD on 312-355-5521 or at ltussing@uic.edu. You may also contact Ece Mutlu, MD, MS, MBA on 312-563-3880 or at Ece_Mutlu@rush.edu.

 

Sponsors/Collaborators

This study is sponsored by Rush University Medical Center, University of Illinois and National Cancer Institute (NCI). The Principal Investigator is Lisa Tussing-Humphreys, PhD, MS, RD.

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