Dietary Patterns, Metabolomics and Colorectal Cancer Risk

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364582
• Other study ID #: OSU-19280
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: July 31, 2022

Study information

• Verified date: November 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173230
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Mortality

Intervention

Other:
• Observed dietary pattern
No intervention will be used. This is an observational study with dietary patterns as main exposure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

References & Publications (2)

Lee DH, Jin Q, Shi N, Wang F, Bever AM, Li J, Liang L, Hu FB, Song M, Zeleznik OA, Zhang X, Joshi A, Wu K, Jeon JY, Meyerhardt JA, Chan AT, Eliassen AH, Clish CB, Clinton SK, Giovannucci EL, Tabung FK. Dietary Inflammatory and Insulinemic Potentials, Plas — View Citation

Lee DH, Jin Q, Shi N, Wang F, Bever AM, Liang L, Hu FB, Song M, Zeleznik OA, Zhang X, Joshi A, Wu K, Jeon JY, Meyerhardt JA, Chan AT, Eliassen AH, Clish C, Clinton SK, Giovannucci EL, Li J, Tabung FK. The metabolic potential of inflammatory and insulinaem — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer risk	Incident colorectal cancer	1986 to 2012 (men), 1984 to 2012 (women)
Secondary	incident total cardiovascular disease, total cancer, chronic respiratory diseases	The incidence of these major chronic diseases will be examined as surrogate for overall health	1986 to 2012 (men), 1984 to 2012 (women)
Secondary	Mortality	Incident death of any cause (as surrogate for overall health)	1986 to 2012 (men), 1984 to 2012 (women)

External Links

•   The Jamesline