Walnuts and Colon Health

Launched by UCONN HEALTH · Jan 4, 2022

Keywords

ClinConnect Summary

This clinical trial, called "Walnuts and Colon Health," is looking to see if eating walnuts can help improve gut health and reduce inflammation in people at risk for colorectal cancer. The study focuses on how adding walnuts to your diet might affect the bacteria in your gut, markers in your blood that show inflammation, and the health of the lining of the colon.

To take part in this study, you need to be between 39 and 75 years old and meet certain criteria, such as having a family history of colorectal cancer or needing a colonoscopy after a positive screening test. If you join, you'll be asked to eat 2 ounces of walnuts every day for three weeks and avoid certain foods and supplements during that time. Additionally, you'll need to provide some blood, urine, and stool samples. This study is open to everyone, regardless of gender, race, or ethnicity, as long as you don’t have certain medical conditions or allergies to walnuts. If you’re interested in participating, you’ll be helping researchers learn more about how diet can impact colon health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Men and women between the ages of 39-75 years old who meet the criteria of one of the following groups and are eligible to undergo a routine screening or surveillance colonoscopy for colorectal cancer (CRC):
• • 1. Individuals who have a family history of colon polyps or CRC in a first-degree relative diagnosed with CRC under the age of 65 years, or
• • 2. Individuals who are referred for colonoscopy following a positive fecal immunochemical test (FIT) or a positive Cologuard screening test and have not had a high-quality colonoscopy in the past 3 years, or
• • 3. Individuals who have a personal history of colon polyps
• • 2. Willing and able to provide written informed consent for study participation
• • 3. Willing to consume 2 ounces (56 grams) of walnuts daily for 3 weeks
• • 4. Willing to avoid intake of EA/ET-rich foods and beverages (e.g., pomegranates, hazelnuts, pistachios, strawberries, raspberries, blackberries, oak-aged wines, and other items on a list given by researchers) and fermented dairy products containing viable Bifidobacteria or Lactobacilli)
• • 5. Willing to stop taking dietary supplements, including probiotics
• • 6. Willing to have two separate blood draws, as well as urine and stool collections
• • 7. Willingness to comply with all study requirements
• Exclusion Criteria:
• • 1. Individual has a personal history of CRC, or a history of any malignancy (other than skin cancer) within the past 5 years
• • 2. Individual meets the Amsterdam criteria for Lynch Syndrome or has a history of familial adenomatous polyposis (FAP)
• • 3. Individual has been treated with immunosuppressive agents or systemic steroids, excluding inhalers, at least two weeks prior to the Screening Visit and for the duration of the study
• • 4. Use of antibiotics at least one month prior to the Screening Visit and for the duration of the study
• • 5. Patients with severe medical illness or those at high risk for anesthesia, as determined by good clinical practice
• • 6. Current evidence or previous history of ulcerative colitis or Crohn's disease
• • 7. Colonoscopy performed for reasons other than screening or surveillance for CRC
• • 8. HIV infection, chronic viral hepatitis
• • 9. Allergy to walnuts or hypersensitivity to tree nuts
• • 10. Peri-menopausal women with any chance or plan of pregnancy
• • 11. Individuals with blood coagulation disorders or on anti-coagulant therapy
• • 12. Any other condition that, in the opinion of the PI, might interfere with study objectives
• • 13. No race/ethnicity, language or gender exclusions for this study