Clinical trial NCT03364582: Dietary Patterns, Metabolomics and Colorectal Cancer Risk
Official title: Dietary Patterns, Metabolomics and Colorectal Cancer Risk and Mortality in the Nurses' Health Study and Health Professionals Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Mortality
Keywords: Dietary patterns
Metabolomics
Mortaltiy
Colorectal cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 173230
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Nurses' Health Study (NHS) and the Health Professionals Follow-up Study (HPFS). The NHS recruited 121,701 registered female nurses aged 30 to 55 years at baseline in 1976, and the HPFS enrolled 51,529 male health professionals aged 40 to 75 years at baseline in 1986 in the United States. In both cohorts, questionnaires were sent at baseline and every two years thereafter to collect and update demographic, lifestyle, medical, and other health-related information. Since the inception of both cohorts, participants have completed self-administered questionnaires every 2 years, providing updated information on medical and lifestyle factors. Every 2 to 4 years, participants receive validated semi-quantitative food frequency questionnaires (FFQ) for dietary assessments.

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.

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

Primary outcomes:
measure: Colorectal cancer risk
timeFrame: 1986 to 2012 (men), 1984 to 2012 (women)
Secondary outcomes:
measure: incident total cardiovascular disease, total cancer, chronic respiratory diseases
timeFrame: 1986 to 2012 (men), 1984 to 2012 (women)
measure: Mortality
timeFrame: 1986 to 2012 (men), 1984 to 2012 (women)
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State Comprehensive Cancer Center
name: Fred Tabung, PhD, MSHP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Plasma Metabolome and Risk of Colorectal Cancer. Metabolites. 2023 Jun 12;13(6):744. doi: 10.3390/metabo13060744.
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 insulinaemic dietary patterns and risk of type 2 diabetes. Diabetologia. 2024 Jan;67(1):88-101. doi: 10.1007/s00125-023-06021-3. Epub 2023 Oct 11.
citation: Petimar J, Smith-Warner SA, Fung TT, Rosner B, Chan AT, Hu FB, Giovannucci EL, Tabung FK. Recommendation-based dietary indexes and risk of colorectal cancer in the Nurses' Health Study and Health Professionals Follow-up Study. Am J Clin Nutr. 2018 Nov 1;108(5):1092-1103. doi: 10.1093/ajcn/nqy171.
citation: Tabung FK, Wang W, Fung TT, Smith-Warner SA, Keum N, Wu K, Fuchs CS, Hu FB, Giovannucci EL. Association of dietary insulinemic potential and colorectal cancer risk in men and women. Am J Clin Nutr. 2018 Aug 1;108(2):363-370. doi: 10.1093/ajcn/nqy093.