Colorectal NeoplasmsMyBestGINCT05396846
MyGI Diet for Colorectal Cancer Prevention
A study testing Eating Plan 1, Eating Plan 2 and Eating Plan 3 in people with Colorectal Neoplasms, run by University of Michigan at 1 site in United States.
Trial summary
This study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org . Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Eating Plan 1, Eating Plan 2 and Eating Plan 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons ages 19 and older
- The subject has been properly informed of the study, they agree to participate, and sign the Informed Consent document(s)
- Measured body mass index of 25-45 kg/m2 at the study eligibility visit months OR waist circumference > 88 cm for women or > 102 cm for men.
- Reasonably stable weight in the last two months
- Increased risk of colorectal cancer as defined by: Prior adenomatous polyp or serrated polyp OR prior resected early stage CRC (Stage I-IIIA or T1-3, N0-1, M0) OR a history of CRC in at least one primary relative or in at least two secondary relatives OR a polyp was found with a recommended follow-up colonoscopy in less than 8 years OR A known genetic condition that increases risk of CRC
- Good general health
Show all 17Show fewer
- Have reasonable control over their own dietary intakes
- Not expecting major lifestyle changes in the next 12 months.
- Not expecting a change in hormonal therapies over the next 12 months
- Have and use a smartphone with web access
- Can be contacted by telephone for support calls
- Read and speak English
- Are able to follow a diet high in fiber-containing foods
- Agree to be randomized to a control condition of usual care versus a dietary intervention involving app use and telephone contacts
- Successfully complete three 24-hour dietary recalls online prior to baseline with plausible dietary intakes
- If taking medications for conditions that are affected by diet (diabetes, high blood pressure) must be willing to continue to follow-up with their personal medical provider as needed to manage those conditions and the medication dosing, which may need to be adjusted due to diet changes.
- Has been properly informed of the study and signed the Informed Consent document
Who cannot join
- Persons with BMI >45 kg/m2 since very high BMI values could indicate more prevalent health problems.
- On medically prescribed diets or other medical contraindications to dietary modification
- Are within 12 months of bariatric surgery
- Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
- Taking anti-coagulants that interfere with ability to obtain a blood sample
- Has a history of cytotoxic treatment (radiation, chemotherapy) for any type cancer within the last 12 months, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment
Show all 14Show fewer
- Have cancer at the present time
- Dietary intakes with substantial nutrient deficiencies that would require extensive counseling to correct, such as obtaining a large portion of calories from alcohol
- Unable to make their own daily food choices
- Showing evidence of lack of reliability or non-adherence to study procedures (for example, missing an eligibility screening or baseline enrollment appointment more than twice; unable to recall the previous day's diet)
- Reported dietary intakes reported that are not plausible or highly unusual as reported on the ASA24 (for example: <500 or >3500 kcal/day for women and <800 or >4200 kcal/day for men; or reporting too few foods eaten)
- Has an infectious disease at the present time (such as HIV or hepatitis C).
- Unable to read, write, or speak English
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org .
Participants in the study will be asked to follow one of three eating plans, as best they can, for 12 months. Study participants can choose the foods they prefer within healthy food groups. Two of the eating plans involve ten brief telephone support calls and use of a web-based app. The study primarily evaluates improvements in eating and any weight change that may result. Secondary goals for the research are to evaluate how changes in eating affect metabolic pathways.
Read more
All study participants will receive written materials that encourage making room for preventive foods in your daily eating. All participants also receive the results of their own diet analyses, and results of their own measures at study visits. The measures are the Veggie Meter skin reflectance test, Ketoscan breath test, and body composition measures. Study visits also involve providing a small blood sample from the arm. Study visits are in Ann Arbor at the start of the study, and at 6 and 12 months.
The long-term goal of this research is to provide better options for supporting individuals who seek to achieve and maintain a preventive style of eating.
Read the detailed description
Despite the large body of research that has identified the impact of diet on cancer risk, little has been done to improve how care is provided to persons who have risk factors for cancer. This study addresses prevention of colorectal cancer, the third most prevalent cancer in the U.S. Colorectal cancer is among the cancers that are most strongly affected by diet and excess adiposity, and incidence is increasing in young people below the age of 40. More efforts need to be directed at providing individuals with the tools needed for achieving and maintaining a preventive style of eating.
Recommendations for cancer prevention from the American Cancer Society and American Institute for Cancer Research include advice to maintain a healthy weight, to consume more plant-based foods, and to limit red meats, processed meats, and foods with added sugar. This study addresses the development of methods that in the future could feasibly be implemented in medical and community settings to assist individuals with risk factors in attaining both the weight management and diet quality goals for prevention of colorectal cancer.
The study seeks to test three dietary interventions in overweight and obese persons who have risk factors for colorectal cancer. Study participants in all groups receive the results of the Veggie Meter, breath ketones using Ketoscan and body composition testing (InBody270) at study visits. A small blood sample from the arm is taken at each visit for research on how eating affects metabolism.
This study will recruit 240 participants who will be randomized to receive to 12 months of: 1) Eating Plan 1, a group that receives written information on cancer preventive diets; 2) Eating Plan 2 that encourages limiting and logging four food groups associated with increased risks, namely foods containing refined flour, added sugars, processed meats, and red meats; or 3) Eating Plan 3 that combines logging of both food groups to limit and preventive food groups to encourage. Eating Plans 2 and 3 will be supported by written educational materials, brief telephone support calls, and the study app. The main outcome is to evaluate to what extent these methods improve eating and possibly achieve weight loss over the year of study.
- Conditions
- Colorectal Neoplasms
- Being tested
- Eating Plan 1, Eating Plan 2, Eating Plan 3
- Keywords
- Prevention, Diet
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating Plan 1Behavioural
The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.
Eating Plan 2Behavioural
The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.
Eating Plan 3Behavioural
The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.
| Study group | Role | What they receive |
|---|---|---|
| Eating Plan 1 | Active comparator | This group will receive a pamphlet from the American Institute for Cancer Research (AICR) on dietary prevention and the results of their own breath test, Veggie Meter score and anthropometric measures. Receives: Behavioral: Eating Plan 1 |
| Eating Plan 2 | Experimental | This group will receive the App and User Manual that encourages limiting four food groups: three or less foods each day made with refined flour, no more than 8% of calories from added sugars, no processed meats and less than 18 oz./week red meat. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures. Receives: Behavioral: Eating Plan 2 |
| Eating Plan 3 | Experimental | This group will receive a version of the App and User Manual that encourages meeting 11 food group goals: four food groups to limit and seven food groups to encourage. The 7 groups to encourage are: 3-4 cups/day fruits and vegetables, at least one dark orange or dark green vegetable daily, daily allium and culinary herbs, 3-6 oz./day whole grains, 6-8 oz./week foods high in omega-3 fatty acids, 8-10 tsp./day olive oil or the equivalent from other foods high in monounsaturated fats and at least ½ cup/day of legumes or 1 TB/day nut butter. Some of the goals are personalized based on calculated energy needs. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures. Receives: Behavioral: Eating Plan 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive Food Score
a score of 10 dietary components (0-10, with 10 being the most optimal score)
Measured: Change over 12 months
Weight Loss
change in weight from baseline (in pounds)
Measured: Change over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start13 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified by self-reported gender (male/female) and randomized across three study arms in a mixed block size, after baseline assessments are completed. Indeterminate gender will be classified as male for the purpose of randomization. The lists will be generated by the study statistician and opaque envelopes will contain the diet arm assignment for sequential participant IDs in the two strata.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Zora Djuric, University of Michigan
- Investigators
- Zora Djuric, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396846
- Sponsor's protocol ID
- HUM00197337
- Other IDs
- R01CA255743
- Acronym
- MyBestGI
- Status last verified
- Jul 2026
- First submitted
- 19 May 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This clinical trial will collect data and blood samples from people enrolled in the trial. The study team is open to sharing de-identified data for collaborative work if the scope of the project falls within what was stated in the consent document used for the study. De-identified, aggregate data will also be available upon request for preparation of review articles and meta-analyses. If biosamples are available for sharing after completion of study measures, all sharing and transfer of human data and biospecimens will occur in accordance with sound scientific and ethical principles and shall comply with all applicable laws, regulations, and the policies of the National Institutes of Health and the University of the Michigan.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyGI Diet for Colorectal Cancer Prevention
- ClinicalTrials.gov ID
- NCT05396846
- Acronym / sponsor ID
- MyBestGI / HUM00197337
- Conditions
- Colorectal Neoplasms
- Keywords
- Prevention, Diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 May 2022 (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.
This study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org .
Participants in the study will be asked to follow one of three eating plans, as best they can, for 12 months. Study participants can choose the foods they prefer within healthy food groups. Two of the eating plans involve ten brief telephone support calls and use of a web-based app. The study primarily evaluates improvements in eating and any weight change that may result. Secondary goals for the research are to evaluate how changes in eating affect metabolic pathways.
All study participants will receive written materials that encourage making room for preventive foods in your daily eating. All participants also receive the results of their own diet analyses, and results of their own measures at study visits. The measures are the Veggie Meter skin reflectance test, Ketoscan breath test, and body composition measures. Study visits also involve providing a small blood sample from the arm. Study visits are in Ann Arbor at the start of the study, and at 6 and 12 months.
The long-term goal of this research is to provide better options for supporting individuals who seek to achieve and maintain a preventive style of eating.
Detailed description
Despite the large body of research that has identified the impact of diet on cancer risk, little has been done to improve how care is provided to persons who have risk factors for cancer. This study addresses prevention of colorectal cancer, the third most prevalent cancer in the U.S. Colorectal cancer is among the cancers that are most strongly affected by diet and excess adiposity, and incidence is increasing in young people below the age of 40. More efforts need to be directed at providing individuals with the tools needed for achieving and maintaining a preventive style of eating.
Recommendations for cancer prevention from the American Cancer Society and American Institute for Cancer Research include advice to maintain a healthy weight, to consume more plant-based foods, and to limit red meats, processed meats, and foods with added sugar. This study addresses the development of methods that in the future could feasibly be implemented in medical and community settings to assist individuals with risk factors in attaining both the weight management and diet quality goals for prevention of colorectal cancer.
The study seeks to test three dietary interventions in overweight and obese persons who have risk factors for colorectal cancer. Study participants in all groups receive the results of the Veggie Meter, breath ketones using Ketoscan and body composition testing (InBody270) at study visits. A small blood sample from the arm is taken at each visit for research on how eating affects metabolism.
This study will recruit 240 participants who will be randomized to receive to 12 months of: 1) Eating Plan 1, a group that receives written information on cancer preventive diets; 2) Eating Plan 2 that encourages limiting and logging four food groups associated with increased risks, namely foods containing refined flour, added sugars, processed meats, and red meats; or 3) Eating Plan 3 that combines logging of both food groups to limit and preventive food groups to encourage. Eating Plans 2 and 3 will be supported by written educational materials, brief telephone support calls, and the study app. The main outcome is to evaluate to what extent these methods improve eating and possibly achieve weight loss over the year of study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be stratified by self-reported gender (male/female) and randomized across three study arms in a mixed block size, after baseline assessments are completed. Indeterminate gender will be classified as male for the purpose of randomization. The lists will be generated by the study statistician and opaque envelopes will contain the diet arm assignment for sequential participant IDs in the two strata.
| Arm | Type | Receives |
|---|---|---|
| Eating Plan 1 | Active comparator | Behavioral: Eating Plan 1This group will receive a pamphlet from the American Institute for Cancer Research (AICR) on dietary prevention and the results of their own breath test, Veggie Meter score and anthropometric measures. |
| Eating Plan 2 | Experimental | Behavioral: Eating Plan 2This group will receive the App and User Manual that encourages limiting four food groups: three or less foods each day made with refined flour, no more than 8% of calories from added sugars, no processed meats and less than 18 oz./week red meat. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures. |
| Eating Plan 3 | Experimental | Behavioral: Eating Plan 3This group will receive a version of the App and User Manual that encourages meeting 11 food group goals: four food groups to limit and seven food groups to encourage. The 7 groups to encourage are: 3-4 cups/day fruits and vegetables, at least one dark orange or dark green vegetable daily, daily allium and culinary herbs, 3-6 oz./day whole grains, 6-8 oz./week foods high in omega-3 fatty acids, 8-10 tsp./day olive oil or the equivalent from other foods high in monounsaturated fats and at least ½ cup/day of legumes or 1 TB/day nut butter. Some of the goals are personalized based on calculated energy needs. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Persons ages 19 and older
- The subject has been properly informed of the study, they agree to participate, and sign the Informed Consent document(s)
- Measured body mass index of 25-45 kg/m2 at the study eligibility visit months OR waist circumference > 88 cm for women or > 102 cm for men.
- Reasonably stable weight in the last two months
- Increased risk of colorectal cancer as defined by: Prior adenomatous polyp or serrated polyp OR prior resected early stage CRC (Stage I-IIIA or T1-3, N0-1, M0) OR a history of CRC in at least one primary relative or in at least two secondary relatives OR a polyp was found with a recommended follow-up colonoscopy in less than 8 years OR A known genetic condition that increases risk of CRC
Key exclusion criteria (14 listed)
- Persons with BMI >45 kg/m2 since very high BMI values could indicate more prevalent health problems.
- On medically prescribed diets or other medical contraindications to dietary modification
- Are within 12 months of bariatric surgery
- Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
- Taking anti-coagulants that interfere with ability to obtain a blood sample
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 |
|---|---|---|
| Eating Plan 1The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers. | Behavioural | Eating Plan 1 |
| Eating Plan 2The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers. | Behavioural | Eating Plan 2 |
| Eating Plan 3The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers. | Behavioural | Eating Plan 3 |
Primary outcome
Preventive Food Score
Time frame: Change over 12 months
a score of 10 dietary components (0-10, with 10 being the most optimal score)
Weight Loss
Time frame: Change over 12 months
change in weight from baseline (in pounds)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Yes. This clinical trial will collect data and blood samples from people enrolled in the trial. The study team is open to sharing de-identified data for collaborative work if the scope of the project falls within what was stated in the consent document used for the study. De-identified, aggregate data will also be available upon request for preparation of review articles and meta-analyses. If biosamples are available for sharing after completion of study measures, all sharing and transfer of human data and biospecimens will occur in accordance with sound scientific and ethical principles and shall comply with all applicable laws, regulations, and the policies of the National Institutes of Health and the University of the Michigan.
Related trials for Colorectal Neoplasms
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Colorectal Cancer, Sarcopenia
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 2
FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer
Ras-mutated Metastatic Colorectal Cancer, mCRC
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.
Zora Djuric, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating Plan 1, Eating Plan 2 and Eating Plan 3 in people with Colorectal Neoplasms, run by University of Michigan at 1 site in United States.
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 17 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Preventive Food Score (time frame: Change over 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.