Dietary Patterns, Metabolomics and Colorectal Cancer Risk

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03364582
• Collaborator: (none)
• Enrollment: 173,230
• Anticipated Duration (Months): 74

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Mortality	Other: Observed dietary pattern

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 Design

• Study Type: Observational
• Actual Enrollment: 173230 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Dietary Patterns, Metabolomics and Colorectal Cancer Risk and Mortality in the Nurses' Health Study and Health Professionals Follow-Up Study
• Actual Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Men-observed dietary pattern Health Professionals Follow-up Study: a prospective cohort of male health professionals	Other: Observed dietary pattern; No intervention will be used. This is an observational study with dietary patterns as main exposure
Women-observed dietary pattern Nurses' Health Study: a prospective cohort of female registered nurses	Other: Observed dietary pattern; No intervention will be used. This is an observational study with dietary patterns as main exposure

Outcome Measures

Primary Outcome Measures

1. Colorectal cancer risk [1986 to 2012 (men), 1984 to 2012 (women)]

   Incident colorectal cancer

Secondary Outcome Measures

1. 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

2. Mortality [1986 to 2012 (men), 1984 to 2012 (women)]

   Incident death of any cause (as surrogate for overall health)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Fred Tabung, PhD, MSHP, Ohio State Comprehensive Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2015

More Information

Additional Information:

• The Jamesline

Publications

None provided.

• Responsible Party: Fred Tabung, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03364582
• Other Study ID Numbers: OSU-19280
• First Posted: Dec 6, 2017
• Last Update Posted: Sep 9, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fred Tabung, Principal Investigator, Ohio State University Comprehensive Cancer Center: Dietary patterns; Metabolomics; Mortaltiy; Colorectal cancer
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Sep 9, 2021