Diet Impact on Colon Cancer Risk

Overseen By Ece Mutlu, MD, MS, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Antibiotics, Anticoagulants, Digestive meds

Disqualifiers: Non-African American, GI illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different diets impact colon cancer risk in African American individuals at an elevated risk for colorectal cancer. Participants will follow either a high-taurine and saturated fat diet or a low-taurine and saturated fat diet to assess the effects on markers linked to cancer risk. The trial seeks African American participants who are obese, have had multiple or large colon polyps in the last five years, and have elevated C-reactive protein levels, indicating inflammation. As an unphased trial, this study offers a unique opportunity to contribute to understanding dietary impacts on cancer risk.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you regularly take medications that interfere with digestion, use antibiotics within the past 2 months, or take anticoagulants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that consuming foods high in taurine and saturated fats might increase the risk of colon cancer. Taurine, often found in animal-based foods, has been linked to a higher chance of developing colon cancer. Saturated fats might also contribute to this risk, especially in individuals genetically prone to the disease. However, some studies have not found a direct connection between dietary fats and cancer risk.

Conversely, diets low in taurine and saturated fats might help reduce the risk of colon cancer. Research suggests that reducing saturated fat intake can lower this risk. Plant-based diets, which contain less animal protein and more fiber, are generally considered safer and may help protect against colon cancer.

In summary, while diets high in taurine and saturated fats may pose some risks, diets low in these components seem better for colon health. Considering these factors is important when thinking about dietary changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary interventions for colon cancer risk because they focus on the potential impact of taurine and saturated fat levels in our diet, which is a fresh angle compared to traditional treatments like surgery, chemotherapy, or radiation. The high taurine and saturated fat diet is unique as it provides a higher dose of these components, possibly highlighting their role in cancer development or prevention. On the other hand, the low taurine and saturated fat diet emphasizes plant-based protein and lower fat content, which could showcase the benefits of reduced animal protein and fat intake. These diets offer a non-invasive approach to potentially lowering cancer risk, making them appealing for further exploration.

What evidence suggests that this trial's diets could be effective for reducing colon cancer risk?

This trial will compare the effects of two diets on colon cancer risk. Research has shown that consuming high levels of taurine and saturated fat may increase the risk of colorectal cancer (CRC). Such a diet raises certain bile acids in the body, which are linked to a higher cancer risk. Participants in one arm of this trial will follow a high taurine and saturated fat diet to assess these effects. Conversely, reducing taurine and saturated fat intake might lower this risk by decreasing these bile acids in the gut, which may help protect against CRC. Participants in another arm will follow a low taurine and saturated fat diet to evaluate its potential protective effects. Overall, evidence suggests that reducing taurine and saturated fat in the diet might help lower the chances of developing colorectal cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa Tussing-Humphreys, PhD, MS, RD

Principal Investigator

University of Illinois at Chicago

Ece Mutlu, MD, MS, MBA

Principal Investigator

Rush University Medical Center

H. Rex Gaskins, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Jason Ridlon, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am an adult African American.

I am between 45 and 75 years old.

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.

Exclusion Criteria

Pregnant or breast feeding

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

I have had a colon perforation or bleeding from colon biopsies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diet Intervention

Participants undergo a controlled crossover diet intervention with two isocaloric diets: a high taurine and saturated fat diet and a low taurine and saturated fat diet, each for 3 weeks.

6 weeks

Baseline and post-diet visits for each diet phase

Follow-up

Participants are monitored for changes in colonocyte proliferation, mucosal abundance of bacterial genes, bile acid metabolism, serum bile acids, colonic mucosal inflammation, and DNA damage.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High taurine and saturated fat diet
• Low in taurine and saturated fat diet

Trial Overview 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.

How Is the Trial Designed?

Group I: Low in taurine and saturated fat diet Experimental Treatment 1 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 diet Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study using a dimethylhydrazine model for colon cancer, rats fed diets high in fat showed an increased incidence and number of tumors, highlighting the role of dietary fat in colon carcinogenesis.

Adding dietary fiber to high-fat diets provided significant protection against tumor development, with complete protection observed when saturated fat was combined with fiber, suggesting that fiber can counteract the harmful effects of fat on colon health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fat/fiber antagonism in experimental colon carcinogenesis. Trudel, JL., Senterman, MK., Brown, RA.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7363648/

Effects of taurocholic acid metabolism by gut bacteria Intake of a high in taurine and saturated fat diet increases liver bile acid secretion and production of taurine conjugated bile acids.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11617591/

Systematic Review and Meta‐Analysis: Taurine and Its ... Taurine was shown to significantly increase odds of CRC. It was also significantly associated with being a discriminator for CRC as a diagnostic metabolite.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03550885

Diet Modulation of Bacterial Sulfur and Bile Acid ... Our research is designed to determine mechanistically why consumption of a high red meat and saturated fat diet imparts risk for CRC development and to ...

4. withpower.com withpower.com/trial/phase-colonic-neoplasms-7-2018-3ea67

Diet Impact on Colon Cancer Risk · Info for Participants Research suggests that a high intake of saturated fat is linked to an increased risk of colon cancer, while reducing saturated fat intake may lower this risk.

5. tandfonline.com tandfonline.com/doi/full/10.1080/19490976.2016.1150414

Taurocholic acid metabolism by gut microbes and colon ... Animal-based diet high in taurine increases TCA levels in liver and gut, and results in higher levels of DCA in the gut than the plant-based diet owing to ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451865420300958

Effects of taurocholic acid metabolism by gut bacteria The taurine conjugated bile salt taurocholic acid (TCA) may be a key component linking diet and CRC risk [15]. Patients with CRC or adenomas have higher fecal ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6315498/

Dietary Fat Intake and Risk of Colorectal Cancer The studies included in this review and meta-analysis revealed that dietary fats and fatty acids had no effects on the risk of CRC.

8. cell.com cell.com/cancer-cell/fulltext/S1535-6108(25)00114-X

Diet-microbiome interactions in cancer In particular, high saturated fat intake promotes obesity, hormonal imbalances, and chronic inflammation, as well as microbiome changes, and has ...