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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: Completed NA study, sponsored by UConn Health.

NCT04066816 is a NA study that has completed, run by UConn Health. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

Interventions

  • OTHER Walnuts

Trial Details

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

178 total trials

What the finished NCT04066816 record still lists

NCT04066816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT04066816 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04066816's enrollment target sits among peer trials

47 1400th of 2000 higher than 599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04066816, the US trial registry maintained by the National Library of Medicine. NCT04066816 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.