Clinical trial · Interventional
Ellagic Acid, Urolithin and Colonic Microbial Communities Affected by Walnut Consumption
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Diet Habit | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Walnuts | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Walnut Consumption
- description
- 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.
- interventionNames
- Other: Walnuts
Primary outcomes (2)
- measure
- Leve of Urolithin of this Population
- timeFrame
- 28 days post walnuts
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women between the ages of 50-65 years old who are scheduled to undergo a routine screening colonoscopy * English speaking/reading patients willing and able to provide written informed consent for study participation * Patients willing to consume walnuts for 3 weeks * Willingness to comply with all study requirements Exclusion Criteria: * Current active malignancy, previous history of gastrointestinal malignancy, or altered gastrointestinal anatomy * Current evidence or previous history of ulcerative colitis or Crohn's disease * HIV infection, chronic viral hepatitis * Allergy to walnuts or hypersensitivity to tree nuts * Use of antibiotics within the past month * Individuals with blood coagulation disorders or on anti-coagulant therapy * Treated with steroids, immunosuppressive agents or other anti-inflammatory drugs one week prior to starting intervention * Non-English-speaking patients who require an interpreter to give consent * Patients residing in the Department of Correction * Inability to comply with the protocol requirements * Any other condition that, in the opinion of the PI, might interfere with study objectives
References
Publications (0)
Data not yet available