Dietary Patterns, Metabolomics and Colorectal Cancer Risk

Completed

• Conditions: Mortality; Colorectal Cancer
• Interventions: Other: Observed dietary pattern

• Registration Number: NCT03364582
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

Colorectal cancer (CRC) is the third most commonly diagnosed cancer in American men and women with ≥130,000 new cases each year. Several dietary patterns have been associated with CRC risk but underlying mechanisms are not fully understood. Researchers thus propose to integrate dietary patterns and metabolomics data to comprehensively investigate biological pathways linking dietary patterns and CRC risk.

Detailed Description

Several dietary patterns have been associated with colorectal cancer (CRC) risk but underlying mechanisms are not fully understood. Also, evidence is lacking on the consistency of dietary guidelines for overall health and CRC prevention given that it is not feasible to have an optimal diet for every disease. Furthermore, metabolomic profiling has not been widely assessed with respect to CRC risk. Metabolomics is uniquely suited to assess metabolic responses to dietary stimuli, given that it is situated downstream to all the other "omics". Building on prior work in hypothesis-driven dietary patterns and CRC prevention, the researchers seek to fill these knowledge gaps by proposing to: 1) use a standardized methodology to compare the best diet for overall health with the best diet for CRC prevention, and further determine if any associations of dietary patterns with CRC prevention are mediated by mechanisms involving inflammation and insulin; 2) determine metabolites that may mediate the association of dietary intake with CRC risk. The researchers will utilize two large prospective cohort studies, the Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS), in which dietary and nondietary data have been collected every 2 to 4 years among 173,230 women and men over the last ≥30 years, with ≥3,400 CRC cases and ≥43,800 all-cause deaths. This integrated interrogation of dietary patterns and metabolomics data will inform the design of guidelines for healthful lifestyles that are optimized for CRC prevention.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173230

Inclusion Criteria

-Adult health professionals

Exclusion Criteria

• Any cancer except nonmelanoma skin cancer
• Did not complete a food frequency questionnaire during follow-up
• Had implausible values for total energy intake (<600 or >3500 kcal/d for women and <800 or >4,200 kcal/d for men) at study entry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men-observed dietary pattern	Observed dietary pattern	Health Professionals Follow-up Study: a prospective cohort of male health professionals
Women-observed dietary pattern	Observed dietary pattern	Nurses' Health Study: a prospective cohort of female registered nurses

Primary Outcome Measures

Name	Time	Method
Colorectal cancer risk	1986 to 2012 (men), 1984 to 2012 (women)	Incident colorectal cancer

Secondary Outcome Measures

Name	Time	Method
incident total cardiovascular disease, total cancer, chronic respiratory diseases	1986 to 2012 (men), 1984 to 2012 (women)	The incidence of these major chronic diseases will be examined as surrogate for overall health
Mortality	1986 to 2012 (men), 1984 to 2012 (women)	Incident death of any cause (as surrogate for overall health)