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NCT06427109 Clinical Trial

Omega-3 Fatty Acid and Colorectal Adenoma

Colorectal Neoplasms Clinical Trial

Official title:
Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06427109
Other study ID # O3FA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date February 21, 2024

Study information
Verified date May 2024
Source DongGuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 798
Est. completion date February 21, 2024
Est. primary completion date November 30, 2023
Accepts healthy volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Dietary intake of omega-3 fatty acid
Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends

Locations
Country Name City State
Korea, Republic of Dongguk University Ilsan Hospital Goyang-si Gyeonggi Province

Sponsors (1)
Lead Sponsor Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Colorectal adenoma among groups with different omega-3 intake levels at the completion of the colonoscopy procedure
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