Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT04211766
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2019-11-20
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.
Detailed Description:
Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-07435 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| RG1006100 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| R21CA245456 | NIH | None | https://reporter.nih.gov/quic… | View |
| 10327 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View |