Colon Cancer Clinical Trial

Walnuts and Colon Health

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.

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Full Description

This is a 29-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 colonoscopy. After being informed about the study and potential risks, participants giving written informed consent will first start a 7-day wash-out period where they will be asked to avoid foods high in ellagitannins for the duration of the study. In addition, participants will be asked to complete food and activity questionnaires, a walnut consumption log, and two sets of 3-day dietary records during their participation in the study. Participants will also be asked to provide three urine samples, two blood samples, and two stool samples at multiple time points, and 8-10 colon tissue specimens (biopsies) will be collected during their colonoscopy procedure for the purposes of this study.

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Eligibility Criteria

Inclusion Criteria:

Individuals in one of the following groups:

Men and women between the ages of 40 to 75 years old, who are scheduled to undergo a routine screening or surveillance colonoscopy for colorectal cancer (CRC) and have a family history of CRC in a first degree relative diagnosed with CRC under the age of 65 years, or
Men and women between the ages of 45 to 75 years old, who are referred for colonoscopy following a positive fecal immunochemical test (FIT) and have not had a high quality colonoscopy in the past 3 years, or
Men and women between the ages of 45 to 75 years old, who have a personal history of colon polyps and are scheduled to undergo a surveillance colonoscopy
Willing and able to provide written informed consent for study participation
Willing to consume 2 ounces of walnuts daily for 3 weeks
Willing to avoid intake of ellagic acid/ellagitannin-rich foods (e.g., pomegranates, hazelnuts, pistachios, strawberries, raspberries, blackberries, oak-aged wines, and other food 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 2 separate blood draws, as well as urine and stool collections
Willing to comply with all study requirements

Exclusion Criteria:

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

200

Study ID:

NCT05195970

Recruitment Status:

Recruiting

Sponsor:

UConn Health

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There are 2 Locations for this study

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UConn Health
Farmington Connecticut, 06032, United States More Info
Nuoxi Fan
Contact
860-679-8703
[email protected]
Slawa Gajewska
Contact
860-679-2939
[email protected]
Daniel W. Rosenberg, Ph.D.
Principal Investigator
John W. Birk, M.D.
Sub-Investigator
Haleh Vaziri, M.D.
Sub-Investigator
Weill Cornell Medicine
New York New York, 10065, United States More Info
Kevin Yeung
Contact
917-250-0889
[email protected]
Steven M. Lipkin, M.D., Ph.D.
Principal Investigator
Felice Schnoll-Sussman, M.D.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

200

Study ID:

NCT05195970

Recruitment Status:

Recruiting

Sponsor:


UConn Health

How clear is this clinincal trial information?

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