## Protocol Section
### Identification Module
**NCT ID:** NCT06427109

**Brief Title:** Omega-3 Fatty Acid and Colorectal Adenoma

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

#### Organization Study ID Info
**ID:** O3FA
#### Organization
**Class:** OTHER
**Full Name:** DongGuk University
### Status Module
#### Completion Date
**Date:** 2024-02-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** DongGuk University

#### Responsible Party

**Investigator Affiliation:** Chung-Ang University

**Investigator Full Name:** Sang Hoon Kim

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Colorectal Neoplasms

- Adenoma Colon

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 798

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Dietary intake of omega-3 fatty acid

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** among groups with different omega-3 intake levels

**Measure:** Incidence of Colorectal adenoma

**Time Frame:** at the completion of the colonoscopy procedure

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 40 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Multi-center, nationwide cohort in Korea

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Goyang-si

**Country:** Korea, Republic of

**Facility:** Dongguk University Ilsan Hospital

**State:** Gyeonggi Province

**Zip:** 14353

#### Overall Officials

**Official 1:**

**Affiliation:** DongGuk University

**Name:** Yun Jeong Lim

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Neoplasms

- ID: M3591

- Name: Adenoma

- Relevance: HIGH

- As Found: Adenoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000236

- Term: Adenoma

- ID: D000015179

- Term: Colorectal Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: HIGH

- As Found: Day 3

### Misc Info Module

- Version Holder: 2024-05-31
