Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption
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|ClinicalTrials.gov Identifier: NCT04066816|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer Colon Cancer Diet Habit||Other: Walnuts||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Walnut Consumption
After screening, participants will avoid foods high in ellagic acid. These foods include pomegranates, hazelnuts, pistachios, strawberries, raspberries, blackberries, oak-aged wines, spirits, and walnuts (besides the ones given by researchers); a complete list will be provided to the subjects. Participants will then return to research facility and provide urine and stool samples, as well as a set of 3-day dietary records. Then, they will start to consume 2 ounces of walnuts per day for 21 days with their usual diet. At the end, they will collect another urine and stool sample as well as another set of dietary records, and then come in for the scheduled colonoscopy where they will be asked to provide biopsy specimens. That completes the intervention and participation in the study.
Participants will consume 2 ounces of walnuts for 21 days
- Leve of Urolithin of this Population [ Time Frame: 28 days post walnuts ]Urolithin will be measure in urine using a mass spectrometer to characterize this population into three know urolithin phenotypes, Uro-A, Uro-B and Uro-0, after walnut consumption.
- Urolithin Phenotype and Colonic Health [ Time Frame: 28 days post walnuts ]Assess biomarkers in colonic mucosa from biopsy samples collected at colonoscopy that are associated with the three different urolithin metabotype following walnut consumption. This biomarkers is a total of 287 genes involved in cellular apoptosis and proliferation, inflammation and senescence, including TIMP1 (used for power calculations), cytokine and T cell and B cell signaling genes, as well as markers of lymphocyte subsets and immune checkpoint pathways and targets, providing a wide range of functional annotation groups.
- Identify Changes in Microbiota and Microbes Responsible for Urolithin Formation Followed by Walnuts Consumption using Metagenomics Sequencing [ Time Frame: Day 7 to Day 28 ]Microbiome will be analyzed before and after walnut consumption with the goal to identify microbes responsible for urolithins production. DNA will be extracted from fecal samples and the V1-3 hyper-variable region of bacterial 16S rRNA genes will be sequenced to analyze bacterial community structure. Although 16S rRNA gene sequencing allows inexpensive bacterial identification to the genus/species level, mWGS will be employed in order to achieve finer classification (strain level), and identify other microbes, including viruses, fungi and small eukaryotes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066816
|Contact: MEG TORO||860.679.8175||MTORO@uchc.edu|
|Contact: AIYANA CALLAS||860.679.7640||CALLAS@uchc.edu|
|United States, Connecticut|
|University of Connecticut Health Center||Recruiting|
|Farmington, Connecticut, United States, 06030|
|Contact: MEG TORO 860-679-8175 MTORO@uchc.edu|
|Principal Investigator: Daniel W Rosenberg, PhD|
|Study Chair:||JOHN BIRK, MD||UConn Health|
|Principal Investigator:||DANIEL W ROSENBERG, PhD||UConn Health|