Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-01-24
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Walnut Consumption
Following enrollment, participants will start a 7-day wash-out period where they will be asked to avoid foods and beverages high in ellagitannins. These include pomegranates, hazelnuts, pistachios, walnuts (besides the samples given by the researchers), strawberries, raspberries, blackberries, oak-aged wines and spirits; a full list of foods and beverages to avoid will be provided. Then, participants will consume 2 ounces of walnuts daily with their usual diet while continuing to avoid ellagitannins for 21 days prior to their routine colonoscopy.
Walnuts
Participants consume 2 ounces of walnuts daily for 21 days
Interventions
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Walnuts
Participants consume 2 ounces of walnuts daily for 21 days
Eligibility Criteria
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Inclusion Criteria
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
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
39 Years
75 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Weill Medical College of Cornell University
OTHER
University of Connecticut
OTHER
California Walnut Commission
OTHER
Spanish National Research Council
OTHER_GOV
University of Florida
OTHER
UConn Health
OTHER
Responsible Party
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Daniel Rosenberg
Professor of Medicine
Principal Investigators
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Daniel W. Rosenberg, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UConn Health
Christian Jobin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UConn Health
Farmington, Connecticut, United States
Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Fan N, Fusco JL, Rosenberg DW. Antioxidant and Anti-Inflammatory Properties of Walnut Constituents: Focus on Personalized Cancer Prevention and the Microbiome. Antioxidants (Basel). 2023 Apr 22;12(5):982. doi: 10.3390/antiox12050982.
Liu H, Birk JW, Provatas AA, Vaziri H, Fan N, Rosenberg DW, Gharaibeh RZ, Jobin C. Correlation between intestinal microbiota and urolithin metabolism in a human walnut dietary intervention. BMC Microbiol. 2024 Nov 15;24(1):476. doi: 10.1186/s12866-024-03626-5.
Moussa MR, Fan N, Birk J, Provatas AA, Mehta P, Hatano Y, Chun OK, Darooghegi Mofrad M, Lotfi A, Aksenov A, Motta VN, Zenali M, Vaziri H, Grady JJ, Nakanishi M, Rosenberg DW. Systemic Inflammation and the Inflammatory Context of the Colonic Microenvironment Are Improved by Urolithin A. Cancer Prev Res (Phila). 2025 Apr 1;18(4):235-250. doi: 10.1158/1940-6207.CAPR-24-0383.
Nakanishi M, Matz A, Klemashevich C, Rosenberg DW. Dietary Walnut Supplementation Alters Mucosal Metabolite Profiles During DSS-Induced Colonic Ulceration. Nutrients. 2019 May 20;11(5):1118. doi: 10.3390/nu11051118.
Chen Y, Nakanishi M, Bautista EJ, Qendro V, Sodergren E, Rosenberg DW, Weinstock GM. Colon Cancer Prevention with Walnuts: A Longitudinal Study in Mice from the Perspective of a Gut Enterotype-like Cluster. Cancer Prev Res (Phila). 2020 Jan;13(1):15-24. doi: 10.1158/1940-6207.CAPR-19-0273. Epub 2019 Dec 9.
Nakanishi M, Chen Y, Qendro V, Miyamoto S, Weinstock E, Weinstock GM, Rosenberg DW. Effects of Walnut Consumption on Colon Carcinogenesis and Microbial Community Structure. Cancer Prev Res (Phila). 2016 Aug;9(8):692-703. doi: 10.1158/1940-6207.CAPR-16-0026. Epub 2016 May 23.
Hong BY, Ideta T, Lemos BS, Igarashi Y, Tan Y, DiSiena M, Mo A, Birk JW, Forouhar F, Devers TJ, Weinstock GM, Rosenberg DW. Characterization of Mucosal Dysbiosis of Early Colonic Neoplasia. NPJ Precis Oncol. 2019 Nov 14;3:29. doi: 10.1038/s41698-019-0101-6. eCollection 2019.
Tomas-Barberan FA, Gonzalez-Sarrias A, Garcia-Villalba R, Nunez-Sanchez MA, Selma MV, Garcia-Conesa MT, Espin JC. Urolithins, the rescue of "old" metabolites to understand a "new" concept: Metabotypes as a nexus among phenolic metabolism, microbiota dysbiosis, and host health status. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201500901. Epub 2016 Jun 20.
Other Identifiers
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21-167JS-1
Identifier Type: -
Identifier Source: org_study_id
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