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Dietary Intervention
Diet Impact on Colon Cancer Risk
N/A
Waitlist Available
Led By Ece Mutlu, MD, MS, MBA
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-diet (day 22) for each of the two 3-week diets
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how two different diets affect gut bacteria in African Americans at higher risk for colorectal cancer. One diet is high in red meat and fats, while the other is plant-based and low in fats. Researchers aim to see if these diets change gut bacteria to produce harmful substances that could increase cancer risk.
Who is the study for?
This trial is for African American adults aged 45-75, who are obese (BMI 30-50), at increased risk for colorectal cancer due to having multiple polyps or a large one in the past five years. They should be generally healthy, post-menopausal if female, and have high C-reactive protein levels. Exclusions include other races, current serious illnesses including heart or kidney disease, recent antibiotic use, and those on diets that affect digestion.
What is being tested?
The study compares two diets: one high in taurine and saturated fat (HT-HSAT) versus another low in these components (LT-LSAT). It aims to see how these diets impact gut bacteria metabolism of bile acids and sulfur compounds related to colon cancer risk factors like inflammation and DNA damage.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include gastrointestinal discomfort or changes in bowel habits as the body adjusts to new food types. Specific side effects will depend on individual reactions to diet alterations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post-diet (day 22) for each of the two 3-week diets
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-diet (day 22) for each of the two 3-week diets
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the mucosal abundance of bacterial genes associated with sulfur and bile acid metabolism
Secondary study objectives
Change in DNA damage
Change in bile acid metabolism
Change in colonic mucosal inflammation
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Low in taurine and saturated fat dietExperimental Treatment1 Intervention
This is a 3-week controlled isocaloric diet containing approximately 7 mg taurine, 36% of calories from fat, 8% of calories from saturated fat, 13% of calories from protein (3:1 plant to animal grams of protein), and 13.5 grams fiber/1000 calories.
Group II: High taurine and saturated fat dietExperimental Treatment1 Intervention
This is a 3-week controlled isocaloric diet containing approximately 125 mg taurine, 40% of calories from fat, 15% of calories from saturated fat, 25% of calories from protein (4:1 animal to plant grams of protein), and 11.5 grams fiber/1000 calories.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer (CRC) include surgery, chemotherapy, radiation therapy, and targeted therapies. These treatments work by removing or killing cancer cells, inhibiting their growth, or targeting specific molecules involved in cancer progression.
Dietary interventions, such as the HT-HSAT and LT-LSAT diets, aim to modulate gut microbiota and bile acid metabolism, which can influence CRC risk and progression. By altering the gut environment, these diets may reduce inflammation, oxidative stress, and DNA damage, potentially lowering CRC risk.
For CRC patients, understanding these mechanisms is crucial as it highlights the potential of dietary modifications to complement traditional treatments and improve outcomes.
Influence of feeding crimped kernel maize silage on the course of subclinical necrotic enteritis in a broiler disease model.
Influence of feeding crimped kernel maize silage on the course of subclinical necrotic enteritis in a broiler disease model.
Find a Location
Who is running the clinical trial?
Rush University Medical CenterOTHER
433 Previous Clinical Trials
218,366 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,793 Total Patients Enrolled
University of Illinois at ChicagoLead Sponsor
635 Previous Clinical Trials
1,568,556 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: High taurine and saturated fat diet
- Group 2: Low in taurine and saturated fat diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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