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Diet Impact on Colon Cancer Risk
Study Summary
This trial will study how taurocholic acid metabolism by gut bacteria affects African American subjects' risk for colorectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had a colon perforation or bleeding from colon biopsies.I have no current cancer except for treated non-melanoma skin cancer.I do not speak English.I am an adult African American.I am not on medications that affect digestion like acarbose or high-dose aspirin.I weigh less than or equal to 450 lbs.You have allergies or strong dislikes to any of the foods used in the trial.I am between 45 and 75 years old.My BMI is between 30 and 50.You have an elevated C-reactive protein (CRP) (defined as > 3 mg/l).I have had a menstrual period in the last 6 months.My liver or kidney function is not severely impaired.I have a positive genetic test for an inherited polyp syndrome.I am between 45 and 75 years old.I have a condition like lupus, scleroderma, or rheumatoid arthritis.My BMI is between 30 and 50.I have had 3 or more polyps or a polyp larger than 1cm in the last 5 years.You have a problem with alcohol or illegal drugs.I have a history of serious heart disease.I am an adult African American.I have not taken antibiotics in the last 2 months.I am on blood thinners or have conditions that make endoscopy risky.I have a history of intestinal cancer, inflammatory bowel disease, celiac disease, or have had weight loss surgery affecting nutrient absorption.I have had 3 or more polyps or a polyp larger than 1cm in the last 5 years.I am a woman who has not had a period in the last 6 months.I have a GI condition other than acid reflux or hemorrhoids.You have taken dietary supplements like probiotics or prebiotics in the last month.I follow a special diet for health reasons or am a vegetarian.
- Group 1: High taurine and saturated fat diet
- Group 2: Low in taurine and saturated fat diet
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are elderly citizens being included in this research?
"The age range for this particular clinical trial is 45 to 75 years old. In contrast, there are 34 trials involving patients below 18 and 808 trials centering around those over 65."
Are new participants still being accepted for this research project?
"That is accurate. The clinical trial detailed on clinicaltrials.gov has open recruitment and was first posted on 8/1/2018. As of the most recent update on 8/22/2022, the study is looking for 44 participants from 1 site."
What are the prerequisites for joining this clinical trial?
"The aim of this clinical study is to enroll 44 African American patients with colorectal carcinoma who meet the following conditions: aged 45-75, have an elevated C-reactive protein, are obese, have an increased risk for CRC as defined by having 3 or more adenomatous polyps or 1 adenomatous polyp larger than 1 cm in the last 5 years, be in good general health without any major lifestyle changes planned in the next 6 months, and finally be willing to maintain their current activity level. This trial is only open to post-menopausal women."
How many people are enrolled in this research project?
"That is right, the listing on clinicaltrials.gov specifies that this research is recruiting patients as we speak. This trial was initially posted on 8/1/2018 and was last updated on 8/22/2022. The team conducting the study needs to enroll 44 individuals from 1 location."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Rush University Medical Center and University of Illinois at Chicago: < 48 hours
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