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

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment High taurine and saturated fat diet, Low in taurine and saturated fat diet for reducing colon cancer risk?

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. Additionally, diets high in fiber are associated with a decreased risk of colon cancer, indicating that dietary changes can influence cancer risk. ^{1 2 3 4 5}

Is a diet high in taurine and saturated fat safe for humans?

Research suggests that high intake of saturated fats may increase the risk of colon cancer, especially in individuals with a high genetic risk. However, some studies in animal models indicate that high saturated fat content might reduce inflammation and tumor growth, but these findings are not directly applicable to humans. ^{3 5 6 7 8}

How does the treatment 'High taurine and saturated fat diet, Low in taurine and saturated fat diet' differ from other treatments for colon cancer?

This treatment is unique because it focuses on dietary modifications, specifically the levels of taurine and saturated fat, to potentially influence colon cancer risk, unlike traditional treatments that may involve surgery, chemotherapy, or radiation. The research suggests that dietary fat type and amount can impact colon cancer development, making this approach novel by targeting diet as a preventive measure. ^{2 3 9 10 11}

Research Team

H. Rex Gaskins, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Jason Ridlon, PhD

Principal Investigator

University of Illinois at Urbana-Champaign

Lisa Tussing-Humphreys, PhD, MS, RD

Principal Investigator

University of Illinois at Chicago

Ece Mutlu, MD, MS, MBA

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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.

My BMI is between 30 and 50.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

[Dietary lipids and experimental colonic carcinogenesis. Critical review of the literature]. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Chemoprevention of colon cancer by dietary fatty acids. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary fat and colon cancer: animal models. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Increased cell membrane arachidonic acid in experimental colorectal tumours. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Saturated fatty acid intake, genetic risk and colorectal cancer incidence: A large-scale prospective cohort study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

High-fat diets rich in saturated fat protect against azoxymethane/dextran sulfate sodium-induced colon cancer. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Dietary factors in relation to the etiology of colorectal cancer. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Diet and metabolism: large-bowel cancer. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The fat/fiber antagonism in experimental colon carcinogenesis. [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The use of epidemiology, scientific data, and regulatory authority to determine risk factors in cancer of some organs of the digestive system. 4. Colon cancer. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Dietary fat and its relationship to large bowel cancer. [2017]