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N/A

Walnuts for Colon Health

N/A

Recruiting

Led By Daniel W. Rosenberg, Ph.D.

Research Sponsored by UConn Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women between the ages of 45 to 75 years old, with a personal history of colon polyps scheduled for surveillance colonoscopy

Men and women between the ages of 40 to 75 years old, scheduled for routine screening or surveillance colonoscopy for colorectal cancer (CRC) with a family history of CRC in a first-degree relative diagnosed under the age of 65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7 and day 29

Awards & highlights

Study Summary

This trial will study the effects of walnuts on gut bacteria, inflammation, and colon health.

Who is the study for?

This trial is for men and women aged 40-75 who are due for a colonoscopy, have a family history of colorectal cancer (CRC), or had positive fecal tests/colon polyps. Participants must not take dietary supplements/probiotics, avoid certain foods, and be willing to eat walnuts daily. Exclusions include walnut allergy, recent cancer other than skin cancer, severe illnesses, immune disorders, antibiotic use within the last month, and blood coagulation issues.Check my eligibility

What is being tested?

The study investigates if eating walnuts affects gut bacteria populations and reduces inflammation in the colon lining. Participants will consume two ounces of walnuts every day for three weeks while avoiding specific foods that could influence the results.See study design

What are the potential side effects?

Potential side effects from consuming walnuts may include digestive discomfort or allergic reactions in those with tree nut sensitivities. However, these are generally considered safe when eaten as part of a regular diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 45 and 75 years old and have a history of colon polyps.

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I am between 40-75 years old and have a family history of early-onset colorectal cancer.

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I am 45-75 years old and referred for a colonoscopy due to a positive FIT test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7 and day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7 and day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 and day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Association of urolithin levels with presence (and type) of colonic lesions

Bacterial composition and taxonomy changes in the fecal microbiome

Bacterial diversity changes and strain-level variations in the fecal microbiome

+4 more

Secondary outcome measures

Bile acid metabolism in stool

Correlation of dietary behavior with fecal microbiome composition and diversity

Correlation of dietary behavior with presence (or absence) of colonic polyps

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Walnut ConsumptionExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Jackson Laboratory for Genomic MedicineUNKNOWN

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,676 Total Patients Enrolled

Weill Medical College of Cornell UniversityOTHER

1,055 Previous Clinical Trials

1,316,095 Total Patients Enrolled

Media Library

Walnuts (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05195970 — N/A

Colorectal Cancer Research Study Groups: Walnut Consumption

Colorectal Cancer Clinical Trial 2023: Walnuts Highlights & Side Effects. Trial Name: NCT05195970 — N/A

Walnuts (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195970 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any opportunities to join this research effort?

"According to the official record, this medical trial is still open for participants and was initially listed on January 24th 2022. Most recently, it underwent an edit in November 15th 2022."

Answered by AI

What is the overarching aim of this clinical investigation?

"The primary aim of this clinical trial, which will be assessed over a period of Day 0 to Day 29, is to evaluate alterations in the bacterial composition and taxonomy of the fecal microbiome. Additional outcomes encompass measuring short-chain fatty acid concentrations in freeze-dried stool samples using differential mobility separation at day 7 (post-washout/pre-walnut supplementation) and day 28 (post walnut supplementation). Furthermore, correlations between dietary habits as documented on food questionnaires with presence or absence of colonic polyps during endoscopy examination at day 29 will also be examined. Lastly, diet behavior data obtained from 3-day"

Answered by AI

What is the uppermost threshold of participants taking part in this experiment?

"Affirmative. According to the clinicaltrials.gov, this medical trial that initially debuted on January 24th 2022 is recruiting participants at present. The enrollment calls for 200 individuals from two separate sites."

Answered by AI

Is there an eligibility criteria for participating in this medical experiment?

"To gain admittance to this trial, applicants must have healthy lifestyle habits and reside between the ages of 40 and 75. This clinical study is aiming to recruit a cohort of 200 individuals."

Answered by AI

Does this clinical trial admit geriatric participants?

"This trial is only accepting applications from participants between the ages of 40 to 75. Conversely, there are 39 separate trials that accept individuals under 18 and 1068 for senior citizens over 65 years old."

Answered by AI