NCT06427109

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
798

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 16, 2024

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of Colorectal adenoma

    among groups with different omega-3 intake levels

    at the completion of the colonoscopy procedure

Interventions

Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Multi-center, nationwide cohort in Korea

You may qualify if:

  • all patients aged more than 40 years of age, scheduled for elective colonoscopy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi Province, 14353, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Yun Jeong Lim

    DongGuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 23, 2024

Study Start

November 1, 2021

Primary Completion

November 30, 2023

Study Completion

February 21, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations