What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include surgery, chemotherapy, radiation therapy, and targeted therapy. Surgery can lead to complications such as infection, bleeding, and bowel dysfunction. Chemotherapy often causes side effects like nausea, vomiting, diarrhea, fatigue, and increased risk of infection. Radiation therapy can result in skin irritation, fatigue, and gastrointestinal issues such as diarrhea and rectal bleeding. Targeted therapies may cause side effects including skin problems, high blood pressure, and gastrointestinal perforations. Nutritional interventions, like the walnut study, aim to improve gut health and reduce inflammation, potentially offering a complementary approach with fewer side effects.

What prior FDA approvals exist?

FDA-approved treatments for colorectal cancer include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. Chemotherapeutic agents such as 5-fluorouracil (5-FU) and capecitabine are commonly used. Targeted therapies include bevacizumab, cetuximab, and panitumumab, which target specific pathways involved in cancer growth. Immunotherapies like pembrolizumab and nivolumab have also been approved for certain cases. While these treatments are not directly related to the nutritional and bioactive components studied in the walnut trial, they represent the current standard of care for managing colorectal cancer.

What other types of research exist?

Promising alternatives to walnuts for colorectal cancer patients include omega-3 fatty acids (found in fish oil), probiotics (such as bifidobacterial species), and dietary fiber (from whole grains, fruits, and vegetables). These components have been shown to positively influence gut microbiota, reduce inflammation, and support colon health.

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N/A

Walnuts for Colon Health

N/A

Recruiting

Led By Daniel W. Rosenberg, Ph.D.

Research Sponsored by UConn Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women between the ages of 45 to 75 years old, with a personal history of colon polyps scheduled for surveillance colonoscopy

Men and women between the ages of 40 to 75 years old, scheduled for routine screening or surveillance colonoscopy for colorectal cancer (CRC) with a family history of CRC in a first-degree relative diagnosed under the age of 65 years

Must not have

HIV infection, chronic viral hepatitis

Use of antibiotics within one month prior to the Screening Visit and for the study duration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7 and day 29

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if eating walnuts daily can improve gut bacteria, reduce inflammation, and benefit colon tissue in people having a colonoscopy. Walnuts have been shown in animal studies to inhibit colorectal cancer growth and alter gut microbiota.

Who is the study for?

This trial is for men and women aged 40-75 who are due for a colonoscopy, have a family history of colorectal cancer (CRC), or had positive fecal tests/colon polyps. Participants must not take dietary supplements/probiotics, avoid certain foods, and be willing to eat walnuts daily. Exclusions include walnut allergy, recent cancer other than skin cancer, severe illnesses, immune disorders, antibiotic use within the last month, and blood coagulation issues.

What is being tested?

The study investigates if eating walnuts affects gut bacteria populations and reduces inflammation in the colon lining. Participants will consume two ounces of walnuts every day for three weeks while avoiding specific foods that could influence the results.

What are the potential side effects?

Potential side effects from consuming walnuts may include digestive discomfort or allergic reactions in those with tree nut sensitivities. However, these are generally considered safe when eaten as part of a regular diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 75 years old and have a history of colon polyps.

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I am between 40-75 years old and have a family history of early-onset colorectal cancer.

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I am 45-75 years old and referred for a colonoscopy due to a positive FIT test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV or chronic viral hepatitis.

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I haven't taken antibiotics in the last month and won't during the study.

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I meet the criteria for Lynch Syndrome or have a history of FAP.

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I haven't taken immunosuppressants or steroids (except inhalers) in the last two weeks.

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I have a blood clotting disorder or am on blood thinners.

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I have a severe illness or am at high risk for anesthesia.

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I have had colorectal cancer or another cancer (except skin cancer) in the last 5 years.

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I have or had ulcerative colitis or Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7 and day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7 and day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Association of urolithin levels with presence (and type) of colonic lesions

Bacterial composition and taxonomy changes in the fecal microbiome

Bacterial diversity changes and strain-level variations in the fecal microbiome

+4 more

Secondary study objectives

Bile acid metabolism in stool

Correlation of dietary behavior with fecal microbiome composition and diversity

Correlation of dietary behavior with presence (or absence) of colonic polyps

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Walnut ConsumptionExperimental Treatment1 Intervention

Following enrollment, participants will start a 7-day wash-out period where they will be asked to avoid foods and beverages high in ellagitannins. These include pomegranates, hazelnuts, pistachios, walnuts (besides the samples given by the researchers), strawberries, raspberries, blackberries, oak-aged wines and spirits; a full list of foods and beverages to avoid will be provided. Then, participants will consume 2 ounces of walnuts daily with their usual diet while continuing to avoid ellagitannins for 21 days prior to their routine colonoscopy.

0 / 11Eligibility criteria met

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 include surgery to remove tumors, chemotherapy to kill cancer cells, radiation therapy to destroy cancerous tissue, and targeted therapies that focus on specific molecular targets within cancer cells. Nutritional and bioactive components, such as those found in walnuts, can influence gut microbiota and reduce inflammation, which are crucial for maintaining colon health. These mechanisms are important for colorectal cancer patients because a healthy gut microbiota and reduced inflammation can potentially lower the risk of cancer progression and improve overall treatment outcomes.

Microbiota and cancer: host cellular mechanisms activated by gut microbial metabolites.Dietary walnut suppression of colorectal cancer in mice: Mediation by miRNA patterns and fatty acid incorporation.