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Trial: 1Herb: 1Links: 1
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1290
- Evidence Id
- 1290
- Core Evidence Id
- 1290
- Source Clinical Trial Id
- 1272
- Herb2 Clinical Trial Id
- HBCT001272
- Nct Id
- NCT05195970
- Title
- Walnuts and Colon Health
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- Colorectal Cancer|Diet Habit
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
- Intervention
- OTHER: Walnuts
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Prevention
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 200
- Outcome Measure
- Bacterial composition and taxonomy changes in the fecal microbiome, Bacterial composition and taxonomy changes in the fecal microbiome will be assessed using 16 Svedberg unit (16S) ribosomal ribonucleic acid (rRNA) sequencing, at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation)., Day 7 and Day 28|Bacterial diversity changes and strain-level variations in the fecal microbiome, Bacterial diversity/abundance changes and strain-level variations in the fecal microbiome will be assessed using metagenomic shotgun sequencing at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation)., Day 7 and Day 28|Bacterial gene expression profile changes in the fecal microbiome, Bacterial gene expression profile changes in the fecal microbiome will be assessed using metagenomic ribonucleic acid (RNA) sequencing at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation)., Day 7 and Day 28|Urolithin levels in urine, Urolithin levels will be measured in urine by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry at day 0 (baseline/pre-washout), day 7 (post-washout/pre-walnut supplementation) and day 29 (post-walnut supplementation/end of study)., Day 0, Day 7 and Day 29|Association of urolithin levels with presence (and type) of colonic lesions, Baseline urolithin levels measured in the urine by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry will be associated with the presence (and type) of colonic lesions (e.g., advanced adenomas (AAs) or sessile serrated adenoma/polyps (SSA/Ps)) detected during the colonoscopy procedure at the end of the study (day 29)., Day 29|Correlation of urolithin levels with fecal microbiome composition, Detailed statistical analyses will be used to correlate urolithin formation with the composition of the fecal microbiome at day 7 (post-washout/pre-walnut supplementation) and at day 28 (post-walnut supplementation)., Day 7 and Day 28|Correlation of colonic lesion gene expression with urolithin production, Colonic lesion (AAs and SSA/Ps) biopsies obtained at the end of the study (day 29) during the colonoscopy procedure will undergo DNA sequence-based analysis to determine gene expression profiling. These results will be compared to urinary urolithin levels measured at baseline to establish correlations between urolithin production and colorectal cancer risk markers., Day 29
- Sponsor Collaborator
- UConn Health|National Institutes of Health (NIH)|National Cancer Institute (NCI)|Weill Medical College of Cornell University|University of Connecticut|California Walnut Commission|Spanish National Research Council|University of Florida
- Funded By
- OTHER
- Location
- UConn Health, Farmington, Connecticut, 06032, United States|Weill Cornell Medicine, New York, New York, 10065, United States
- Other Id
- 21-167JS-1|1R01CA252045-01A1
- Start Date
- 2022-01-24
- Primary Completion Date
- 2025-12-31
- Completion Date
- 2026-12-31
- First Posted
- 2022-01-19
- Results First Posted
- Last Update Posted
- 2024-03-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05195970
- Title Cn
- Title En
- Walnuts and Colon Health
- Bilingual Status
- semi_complete