Colorectal CancerNCT03364582
Dietary Patterns, Metabolomics and Colorectal Cancer Risk
An observational study of Colorectal Cancer and Mortality, run by Ohio State University Comprehensive Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Mortality
- What is being tested?
- Observed dietary pattern
- How many people
- 173,230 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- -Adult health professionals
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Mortality
- Being tested
- Observed dietary pattern
- Keywords
- Dietary patterns, Metabolomics, Mortaltiy, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observed dietary patternOther
No intervention will be used. This is an observational study with dietary patterns as main exposure
| Study group | Role | What they receive |
|---|---|---|
| Men-observed dietary pattern | Health Professionals Follow-up Study: a prospective cohort of male health professionals Receives: Other: Observed dietary pattern | |
| Women-observed dietary pattern | Nurses' Health Study: a prospective cohort of female registered nurses Receives: Other: Observed dietary pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer risk
Incident colorectal cancer
Measured: 1986 to 2012 (men), 1984 to 2012 (women)
Secondary outcomes (2)
incident total cardiovascular disease, total cancer, chronic respiratory diseases
The incidence of these major chronic diseases will be examined as surrogate for overall health
Measured: 1986 to 2012 (men), 1984 to 2012 (women)
Mortality
Incident death of any cause (as surrogate for overall health)
Measured: 1986 to 2012 (men), 1984 to 2012 (women)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jun 2016
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173,230 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Tabung, Ohio State University Comprehensive Cancer Center
- Investigators
- Fred Tabung, PhD, MSHP, Principal investigator, Ohio State Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364582
- Sponsor's protocol ID
- OSU-19280
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2017
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37367904Lee 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.
PubMed 37816982Petimar 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.
PubMed 30289433Tabung 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.
PubMed 29901698
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Patterns, Metabolomics and Colorectal Cancer Risk and Mortality in the Nurses' Health Study and Health Professionals Follow-Up Study
- ClinicalTrials.gov ID
- NCT03364582
- Acronym / sponsor ID
- OSU-19280
- Conditions
- Colorectal Cancer, Mortality
- Keywords
- Dietary patterns, Metabolomics, Mortaltiy, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173,230 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men-observed dietary pattern | – | Other: Observed dietary patternHealth Professionals Follow-up Study: a prospective cohort of male health professionals |
| Women-observed dietary pattern | – | Other: Observed dietary patternNurses' Health Study: a prospective cohort of female registered nurses |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -Adult health professionals
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observed dietary patternNo intervention will be used. This is an observational study with dietary patterns as main exposure | Other | Men-observed dietary pattern, Women-observed dietary pattern |
Primary outcome
Colorectal cancer risk
Time frame: 1986 to 2012 (men), 1984 to 2012 (women)
Incident colorectal cancer
2 secondary outcomes
incident total cardiovascular disease, total cancer, chronic respiratory diseases
Time frame: 1986 to 2012 (men), 1984 to 2012 (women)
Mortality
Time frame: 1986 to 2012 (men), 1984 to 2012 (women)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Results publication: PubMed 37367904Lee 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.
- Results publication: PubMed 37816982Lee 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.
- Derived from this study: PubMed 30289433Petimar 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.
- Derived from this study: PubMed 29901698Tabung 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.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Tabung, PhD, MSHP principal investigator
Ohio State Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Mortality, run by Ohio State University Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer risk (time frame: 1986 to 2012 (men), 1984 to 2012 (women)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364582, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.