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Completed

NCT Number: NCT03364582

Dietary Patterns, Metabolomics and Colorectal Cancer Risk

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observed dietary pattern

Other

No intervention will be used. This is an observational study with dietary patterns as main exposure

Primary outcomes

  1. Colorectal cancer risk

    Time frame: 1986 to 2012 (men), 1984 to 2012 (women)

    Incident colorectal cancer

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2017
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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