Dietary Patterns, Metabolomics and Colorectal Cancer Risk

NCT ID: NCT03364582

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Mortality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Men-observed dietary pattern

Health Professionals Follow-up Study: a prospective cohort of male health professionals

Observed dietary pattern

Intervention Type OTHER

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

Observed dietary pattern

Intervention Type OTHER

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

Interventions

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Observed dietary pattern

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Tabung

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fred Tabung, PhD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Ohio State Comprehensive Cancer Center

References

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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.

Reference Type RESULT
PMID: 37367904 (View on PubMed)

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.

Reference Type RESULT
PMID: 37816982 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30289433 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29901698 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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OSU-19280

Identifier Type: -

Identifier Source: org_study_id

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