RECRUITING

Walnuts and Colon Health

Conditions

Colorectal Cancer Diet Habit Microbiome Urolithin Walnuts Inflammatory markers Colon inflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Microbiota, Metabolites and Colon Neoplasia

Quick Facts

Study Start:2022-01-24

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05195970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:39 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 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 * 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 (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 two separate blood draws, as well as urine and stool collections * Willingness to comply with all study requirements	* 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

Inclusion Criteria

Exclusion Criteria

* 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 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
* 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 (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 two separate blood draws, as well as urine and stool collections
* Willingness to comply with all study requirements

* 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

Contacts and Locations

Study Contact

Nuoxi Fan

CONTACT

860-679-8703

nfan@uchc.edu

Slawa Gajewska

CONTACT

860-679-2939

gajewska@uchc.edu

Principal Investigator

Daniel W. Rosenberg, Ph.D.

PRINCIPAL_INVESTIGATOR

UConn Health

Study Locations (Sites)

UConn Health

Farmington, Connecticut, 06032

United States

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: UConn Health

Daniel W. Rosenberg, Ph.D., PRINCIPAL_INVESTIGATOR, UConn Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-24

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-01-24

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Colorectal cancer
Microbiome
Urolithin
Walnuts
Diet habit
Inflammatory markers
Colon inflammation

Additional Relevant MeSH Terms

Colorectal Cancer
Diet Habit