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Clinical Trials/NCT03364582
NCT03364582
Completed
Not Applicable

Dietary Patterns, Metabolomics and Colorectal Cancer Risk and Mortality in the Nurses' Health Study and Health Professionals Follow-Up Study

Ohio State University Comprehensive Cancer Center0 sites173,230 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Ohio State University Comprehensive Cancer Center
Enrollment
173230
Primary Endpoint
Colorectal cancer risk
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fred Tabung

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Colorectal cancer risk

Time Frame: 1986 to 2012 (men), 1984 to 2012 (women)

Incident colorectal cancer

Secondary Outcomes

  • incident total cardiovascular disease, total cancer, chronic respiratory diseases(1986 to 2012 (men), 1984 to 2012 (women))
  • Mortality(1986 to 2012 (men), 1984 to 2012 (women))

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