What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include surgery, chemotherapy, radiation therapy, and targeted therapies. These treatments can have various side effects. Surgery may lead to pain, infection, and bowel dysfunction. Chemotherapy often causes nausea, vomiting, diarrhea, fatigue, and increased risk of infection. Radiation therapy can result in skin irritation, fatigue, and gastrointestinal issues. Targeted therapies may cause skin problems, hypertension, and gastrointestinal symptoms. For dietary interventions like the HT-HSAT and LT-LSAT diets, which aim to modulate gut microbiota and bile acid metabolism, specific side effects are not well-documented, but potential issues could include gastrointestinal discomfort, changes in bowel habits, and nutrient imbalances.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including chemotherapy agents like 5-fluorouracil, targeted therapies such as bevacizumab and cetuximab, and immunotherapies like pembrolizumab. While these treatments primarily focus on direct cancer cell targeting, there is growing interest in dietary interventions that modulate gut microbiota and bile acid metabolism, similar to the HT-HSAT and LT-LSAT diets studied for their impact on colorectal cancer risk markers. These dietary approaches aim to reduce cancer risk by altering the gut environment, though specific FDA-approved treatments based solely on dietary modulation are not yet established.

What other types of research exist?

Promising novel alternatives for colorectal cancer patients in 2024 include: 1) Probiotic and prebiotic supplementation to modulate gut microbiota, 2) Dietary fiber intake, particularly from cereals, to improve gut health and reduce CRC-specific mortality, 3) Omega-3 fatty acids to reduce inflammation and support gut health, and 4) Mediterranean diet, which is easier to comply with and beneficial for overall health. These alternatives focus on improving gut microbiota composition and reducing inflammation, which are crucial for CRC management.

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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

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

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 more

Awards & 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.

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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.

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