- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06427109
Omega-3 Fatty Acid and Colorectal Adenoma
May 23, 2024 updated by: Sang Hoon Kim, DongGuk University
Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma
Patients aged >40 years who underwent elective colonoscopies were recruited from ten institutions.
Patients with a history of colorectal cancer or long-term dietary interventions were excluded.
Participants completed a food frequency questionnaire (FFQ) prior to endoscopy.
FFQ data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately.
Colonoscopy outcome data, including the adenoma number, pathology, and location, were collected.
Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using P for trend analysis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
798
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gyeonggi Province
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Goyang-si, Gyeonggi Province, Korea, Republic of, 14353
- Dongguk University Ilsan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Multi-center, nationwide cohort in Korea
Description
Inclusion Criteria:
- all patients aged more than 40 years of age, scheduled for elective colonoscopy.
Exclusion Criteria:
- inflammatory bowel diseases
- history of colorectal neoplasms
- prior gastrointestinal surgery
- substance abuse including alcohol
- an inability to complete the survey due to emergency endoscopy
- cognitive impairments and those undergoing significant dietary modifications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Colorectal adenoma
Time Frame: at the completion of the colonoscopy procedure
|
among groups with different omega-3 intake levels
|
at the completion of the colonoscopy procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yun Jeong Lim, DongGuk University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
February 21, 2024
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 21, 2024
First Posted (Actual)
May 23, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 23, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenoma
Other Study ID Numbers
- O3FA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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