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Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption

NCT04066816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-11-26

No results posted yet for this study

Summary

Briefly, this is a 28-day dietary intervention study participants will be asked to eat 2 ounces (52 grams) of walnuts every day for 3 weeks, and at the end of the study period they will come in for a colonoscopy. Participants will first start a 1-week run-in period where they will be asked to avoid foods high in ellagic acid. In addition, they will be asked to complete food surveys and two sets of 3-day dietary records, and to provide colon biopsies for this study during their routine colonoscopy, as well as a blood, and two urine and stool samples. Urine samples will be used for analysis of urolithin, ellagic acid metabolites. Stool samples will be used to assess gut microbiota changes after walnut consumption. Dietary records will be used for compliance and Food Frequency Questionnaire will be used to assess dietary habits. Lastly, the biopsy samples will be used for analysis of biomarkers and anti-inflammatory in the colon, as well as adherent microbiome to the colonic tissue. Data will be analyzed based on the urolithin phenotypes.

Conditions

Interventions

OTHER

Walnuts

Participants will consume 2 ounces of walnuts for 21 days

Sponsors & Collaborators

  • American Institute for Cancer Research

    collaborator OTHER

  • California Walnut Commission

    collaborator OTHER

  • The Jackson Laboratory

    collaborator OTHER

  • UConn Health

    lead OTHER

Principal Investigators

  • JOHN BIRK, MD · UConn Health

  • DANIEL W ROSENBERG, PhD · UConn Health

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2021-04-08
Completion
2021-04-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066816 on ClinicalTrials.gov