Dietary Patterns, Metabolomics and Colorectal Cancer Risk

Study Overview
=================
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.

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

Conditions
-----------------
Colorectal Cancer, Mortality

Intervention / Treatment
-----------------
* Other: Observed dietary pattern


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary patterns, Metabolomics, Mortaltiy, Colorectal cancer