Dietary Patterns, Metabolomics and Colorectal Cancer Risk

• ClinicalTrials.gov Identifier: NCT03364582
• Recruitment Status: Active, not recruiting
• First Posted: December 6, 2017
• Last Update Posted: September 9, 2021
• Sponsor: Ohio State University Comprehensive Cancer Center
• Information provided by (Responsible Party): Fred Tabung, Ohio State University Comprehensive Cancer Center

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
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: June 1, 2016
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: July 31, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Colorectal cancer risk [ Time Frame: 1986 to 2012 (men), 1984 to 2012 (women) ]
   Incident colorectal cancer

Secondary Outcome Measures :

1. incident total cardiovascular disease, total cancer, chronic respiratory diseases [ Time Frame: 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 [ Time Frame: 1986 to 2012 (men), 1984 to 2012 (women) ]
   Incident death of any cause (as surrogate for overall health)

Biospecimen Retention:   Samples Without DNA

Plasma samples to analyze for inflammatory, insulin response biomarkers and metabololites

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

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)

Documents provided by Fred Tabung, Ohio State University Comprehensive Cancer Center:

Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2015

More Information

Additional Information:

The Jamesline 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Individual Participant Data (IPD) Sharing Statement:

• 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, Ohio State University Comprehensive Cancer Center:

Dietary patterns; Metabolomics; Mortaltiy; Colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases