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Dietary Intervention

Diet Impact on Colon Cancer Risk

N/A
Waitlist Available
Led By Jason Ridlon, PhD
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
Adult African American;
Age between 45 - 75 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

Study Summary

This trial will study how taurocholic acid metabolism by gut bacteria affects African American subjects' risk for colorectal cancer.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult African American.
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I am between 45 and 75 years old.
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My BMI is between 30 and 50.
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I am between 45 and 75 years old.
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My BMI is between 30 and 50.
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I have had 3 or more polyps or a polyp larger than 1cm in the last 5 years.
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I am an adult African American.
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I have had 3 or more polyps or a polyp larger than 1cm in the last 5 years.
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I am a woman who has not had a period in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-diet (day 22) for each of the two 3-week diets
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-diet (day 22) for each of the two 3-week diets for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the mucosal abundance of bacterial genes associated with sulfur and bile acid metabolism
Secondary outcome measures
Change in DNA damage
Change in bile acid metabolism
Change in colonic mucosal inflammation
+2 more

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.

Find a Location

Who is running the clinical trial?

Rush University Medical CenterOTHER
418 Previous Clinical Trials
162,455 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,606 Previous Clinical Trials
40,913,443 Total Patients Enrolled
University of Illinois at ChicagoLead Sponsor
602 Previous Clinical Trials
1,558,467 Total Patients Enrolled

Media Library

High taurine and saturated fat diet (Dietary Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03550885 — N/A
Colorectal Cancer Research Study Groups: High taurine and saturated fat diet, Low in taurine and saturated fat diet
Colorectal Cancer Clinical Trial 2023: High taurine and saturated fat diet Highlights & Side Effects. Trial Name: NCT03550885 — N/A
High taurine and saturated fat diet (Dietary Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03550885 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Rush University Medical Center and University of Illinois at Chicago
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Rush University Medical Center and University of Illinois at Chicago: < 48 hours
~7 spots leftby Mar 2025