Walnuts and Colon Health (NCT05195970) | Clinical Trial Compass
CompletedNot Applicable
Walnuts and Colon Health
United States140 participantsStarted 2022-01-24
Plain-language 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.
Who can participate
Age range
39 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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):
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bacterial composition and taxonomy changes in the fecal microbiome
Timeframe: Day 7 and Day 28
2
Bacterial diversity changes and strain-level variations in the fecal microbiome
Timeframe: Day 7 and Day 28
3
Bacterial gene expression profile changes in the fecal microbiome
Timeframe: Day 7 and Day 28
4
Urolithin levels in urine
Timeframe: Day 0, Day 7 and Day 30
5
Association of urolithin levels with presence (and type) of colonic lesions
Timeframe: Day 30
6
Correlation of urolithin levels with fecal microbiome composition
Timeframe: Day 7 and Day 28
7
Correlation of colonic lesion gene expression with urolithin production
. 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
Association of urolithin levels with the immune composition of the tumor microenvironment