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NCT04066816 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by UConn Health.

Completed
Registry status
NA
Development phase
47
Enrollment target

NCT04066816 is a NA study that has completed, run by UConn Health. The registered enrollment target is 47 participants.

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The verdict

NCT04066816, a NA study, has completed, sponsored by UConn Health.

COMPLETED
Registry status
NA
Development phase
47 participants
Enrollment target

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.

Interventions

  • OTHER Walnuts

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2019-05-20
Est. Completion 2021-04-08
Phase NA

Sponsor

UConn Health

178 total trials

What the Registry Record Tells You About NCT04066816

The ClinicalTrials.gov registry entry for NCT04066816 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UConn Health, which has 178 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Walnuts is the first listed.

NCT04066816 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04066816 about?

NCT04066816 is a clinical study titled "Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption". 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 ...

What is the current status of trial NCT04066816?

This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2019-05-20. Estimated completion is 2021-04-08.

What interventions are being tested in trial NCT04066816?

The interventions under investigation include: Walnuts (OTHER).

Who is sponsoring clinical trial NCT04066816?

This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.