|

Walnuts and Colon Health

RECRUITINGN/ASponsored by UConn Health
Actively Recruiting
PhaseN/A
SponsorUConn Health
Started2022-01-24
Est. completion2025-12-31
Eligibility
Age39 Years – 75 Years
Healthy vol.Accepted
Locations2 sites

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 lines the inside of the colon.

Eligibility

Age: 39 Years – 75 YearsHealthy volunteers accepted
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

Conditions3

CancerColorectal CancerDiet Habit

Locations2 sites

Connecticut

1 site
UConn Health
Farmington, Connecticut, 06032
Amy Pallotti860-679-3878apallotti@uchc.edu

New York

1 site
Weill Cornell Medicine
New York, New York, 10065
Thalia Matos347-883-3589thm2013@med.cornell.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.