Status:
RECRUITING
Walnuts and Colon Health
Lead Sponsor:
UConn Health
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Diet Habit
Eligibility:
All Genders
39-75 years
Phase:
NA
Brief Summary
The purpose of this research study is to examine whether adding walnuts to your diet can have a beneficial effect on the gut bacteria population, inflammatory markers in the blood, and the tissue that...
Detailed Description
This is a 30-day dietary intervention study where participants will be asked to consume 2 ounces of walnuts daily for 21 days, and at the end of the study period they will come in for a routine colono...
Eligibility Criteria
Inclusion
- 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):
- 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
- 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
- Individuals who have a personal history of colon polyps
- Willing and able to provide written informed consent for study participation
- Willing to consume 2 ounces (56 grams) of walnuts daily for 3 weeks
- 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)
- Willing to stop taking dietary supplements, including probiotics
- Willing to have two separate blood draws, as well as urine and stool collections
- Willingness to comply with all study requirements
Exclusion
- Individual has a personal history of CRC, or a history of any malignancy (other than skin cancer) within the past 5 years
- Individual meets the Amsterdam criteria for Lynch Syndrome or has a history of familial adenomatous polyposis (FAP)
- 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
- Use of antibiotics at least one month prior to the Screening Visit and for the duration of the study
- Patients with severe medical illness or those at high risk for anesthesia, as determined by good clinical practice
- Current evidence or previous history of ulcerative colitis or Crohn's disease
- Colonoscopy performed for reasons other than screening or surveillance for CRC
- HIV infection, chronic viral hepatitis
- Allergy to walnuts or hypersensitivity to tree nuts
- Peri-menopausal women with any chance or plan of pregnancy
- Individuals with blood coagulation disorders or on anti-coagulant therapy
- Any other condition that, in the opinion of the PI, might interfere with study objectives
- No race/ethnicity, language or gender exclusions for this study
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05195970
Start Date
January 24 2022
End Date
December 31 2026
Last Update
March 18 2025
Active Locations (2)
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1
UConn Health
Farmington, Connecticut, United States, 06032
2
Weill Cornell Medicine
New York, New York, United States, 10065