Dietary Patterns, Metabolomics and Colorectal Cancer Risk

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

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.

Study Overview

• Status: Completed
• Conditions: Mortality; Colorectal Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 173230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal cancer risk	Incident colorectal cancer	1986 to 2012 (men), 1984 to 2012 (women)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Mortality	Incident death of any cause (as surrogate for overall health)	1986 to 2012 (men), 1984 to 2012 (women)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. 2023 Oct 11. doi: 10.1007/s00125-023-06021-3. Online ahead of print.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal cancer; Metabolomics; Dietary patterns; Mortaltiy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: OSU-19280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No