Diet Intervention for Colorectal Cancer Prevention

Overseen By Rob Adwere-Boamah, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Anti-coagulants

Disqualifiers: High BMI, Cancer, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if different healthy eating plans can reduce the risk of colorectal cancer, particularly for those who are overweight or have risk factors such as a family history of the disease. Participants will follow one of three eating plans for a year, selecting preferred foods within healthy guidelines. The study will monitor changes in diet, weight, and metabolic health (how the body processes food). Individuals who have had colorectal cancer or polyps and are generally in good health might be suitable for this study. Participants must be willing to use a smartphone app and participate in support calls. As an unphased trial, this study provides a unique opportunity to contribute to significant research on diet and cancer prevention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications for conditions affected by diet, like diabetes or high blood pressure, you should continue to follow up with your doctor to manage your medication dosing, which might need adjustment due to diet changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that healthy eating habits can safely lower the risk of colorectal cancer. The MyBestGI study examines three different eating plans to improve food choices, based on recommendations known to help prevent cancer.

Participants will follow one of these plans, which encourage consuming more fruits, vegetables, whole grains, and foods high in omega-3 fatty acids. They also recommend reducing intake of processed and red meats, refined flour, and added sugars. Strong evidence supports that these dietary changes can improve health without causing harm.

For example, past studies found that diets high in whole grains and fiber, and low in red and processed meats, are linked to a lower risk of colorectal cancer. This suggests that the eating plans in the study should be easy for participants to follow. Overall, the study aims to identify the best ways to help people adopt a healthy diet to prevent cancer, and these dietary changes are considered safe for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these eating plans for colorectal cancer prevention because they offer a fresh approach to dietary intervention. Unlike standard options that might focus more on medication or surgery, these plans emphasize lifestyle changes with specific dietary goals. For instance, Eating Plan 2 encourages limiting foods high in refined flour and added sugars, while Eating Plan 3 promotes a diverse intake of fruits, vegetables, whole grains, and healthy fats. By using personalized feedback tools like the MyBestGI App and the Veggie Meter, participants receive tailored guidance, potentially leading to more effective prevention strategies. This focus on personalized, actionable dietary changes is what makes these eating plans stand out.

What evidence suggests that this trial's eating plans could be effective for colorectal cancer prevention?

This trial will compare different dietary interventions to assess their impact on colorectal cancer prevention. Research has suggested that reducing foods with refined flour, added sugars, and processed meats, as recommended in Eating Plan 2, may lead to healthier eating habits and possibly reduce cancer risk. Evidence indicates that Eating Plan 3, which emphasizes fruits, vegetables, whole grains, and foods rich in omega-3 fatty acids, can lower the risk of colorectal cancer by 8-17%. Both plans, part of separate arms in this trial, aim to improve food choices to help prevent cancer. Overall, these eating strategies rely on strong research linking diet to a reduced cancer risk. ^{2 3 4 6 7}

Who Is on the Research Team?

Zora Djuric, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This study is for overweight or obese adults with a history of early-stage colorectal cancer or polyps, or who have a family history of these conditions. Participants should be able to control their diet and not expect major lifestyle changes in the next year. They must also be willing to use an app and receive support calls.

Inclusion Criteria

I can be reached by phone for study-related calls.

I am at an increased risk for colorectal cancer.

I am 19 years old or older.

Exclusion Criteria

I currently have an infectious disease.

Persons with BMI >45.5 kg/m2 since very high BMI values could indicate more prevalent health problems

I haven't had cancer treatment in the last year, except for minor skin cancer surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow one of three eating plans for 12 months, with support from telephone calls and a web-based app

12 months

3 visits (in-person) at start, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eating Plan 1
• Eating Plan 2
• Eating Plan 3
• Full Eating Plan
• Self-Guided Eating Plan
• Simple Eating Plan

Trial Overview The MyBestGI study tests three different healthy eating plans over 12 months to see which helps improve diet quality and potentially reduce weight. It includes telephone support, a web-based app, and regular check-ups with body composition measures and blood samples in Ann Arbor.

How Is the Trial Designed?

Group I: Eating Plan 3 Experimental Treatment 1 Intervention

This group will receive a version of the MyBestGI 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.

Group II: Eating Plan 2 Experimental Treatment 1 Intervention

This group will receive the MyBestGI 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.

Group III: Eating Plan 1 Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Colorectal cancer (CRC) screening programs are expected to reduce mortality rates, highlighting the importance of early detection and prevention strategies, especially given that CRC develops over more than 15 years.

The review of 80 meta-analyses suggests that certain factors, such as aspirin and a diet rich in fruits, vegetables, and fiber, may lower CRC incidence, while high alcohol and meat consumption may increase risk; however, the evidence for many interventions remains low or very low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in clinical practice: colorectal cancer chemoprevention in the average-risk population. Chapelle, N., Martel, M., Toes-Zoutendijk, E., et al.[2023]

Flexible sigmoidoscopy was not a significant barrier to recruiting high-risk individuals for a dietary intervention study, as only 16 out of 1314 potential participants cited it as an obstacle.

The most common reason for exclusion from the study was failure to return food records, highlighting the importance of capturing dietary changes between eligibility determination and enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mediterranean dietary intervention in persons at high risk of colon cancer: recruitment and retention to an intensive study requiring biopsies. Djuric, Z., Ruffin, MT., Rapai, ME., et al.[2021]

A diet high in fruits and vegetables, particularly raw ones, is associated with a probable reduction in colorectal cancer risk, while high consumption of refined white flour products and sweets may increase risk, although evidence is still insufficient.

Obesity, especially visceral obesity, is convincingly linked to an increased risk of colorectal cancer, highlighting the importance of maintaining a healthy weight through a balanced diet rich in whole grains, legumes, and low-fat dairy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition and colorectal cancer]. Ströhle, A., Maike, W., Hahn, A.[2017]

A healthy dietary pattern, as measured by the Healthy Eating Index (HEI), is associated with a reduced risk of colorectal cancer, especially in men, with hazard ratios indicating significant protective effects against overall colorectal cancer and specific subsites like colon and proximal colon cancer.

The study, which included a large cohort of 3185 women and 2622 men, found that higher HEI scores correlated with lower cancer risk across various groups, including normal weight and physically inactive participants, suggesting that diet plays a crucial role in colorectal cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of the healthy eating index with risk of colorectal cancers (overall and by subsite) among Canadians. Arthur, RS., Kirsh, VA., Rohan, TE.[2023]

In a study of 442 patients with a history of colorectal adenomas, the Mediterranean dietary pattern, characterized by high consumption of olive oil, vegetables, fruit, fish, and lean meat, was associated with a significant reduction in adenoma recurrence among women.

No significant associations were found between other dietary patterns (like 'Sweets and snacks' or 'High fat and proteins' for men, and 'Western' or 'Snacks' for women) and adenoma recurrence, indicating that the Mediterranean diet may be particularly beneficial for reducing colorectal cancer risk in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and the risk of colorectal adenoma recurrence in a European intervention trial. Cottet, V., Bonithon-Kopp, C., Kronborg, O., et al.[2022]

In a study of 1196 colorectal cancer survivors, only 12% adhered to 6 or more of the World Cancer Research Foundation/American Institute for Cancer Research dietary and lifestyle recommendations, indicating a significant opportunity for improvement in healthy lifestyle practices among this group.

The recommendation to limit meat consumption had the lowest adherence at 8%, while the guideline against dietary supplements had the highest adherence at 75%, suggesting varying levels of acceptance and implementation of dietary advice among survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to the World Cancer Research Fund/American Institute for Cancer Research lifestyle recommendations in colorectal cancer survivors: results of the PROFILES registry. Winkels, RM., van Lee, L., Beijer, S., et al.[2021]

Patients with colorectal cancer showed significant weight loss during treatment, but their muscle mass remained stable, indicating that while they may lose weight, their overall strength could be preserved.

Nutrition education provided by clinical dietitians led to improved dietary habits among patients, with increased consumption of diverse food groups, suggesting that ongoing nutritional support can enhance nutritional status and potentially aid in disease prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Continuous Nutrition Care on Nutritional Status and Dietary Habits of Patients With Colorectal Cancer Receiving Adjuvant Chemotherapy After Surgery. Son, J., Kang, HI., Jung, EY., et al.[2023]

Diet plays a crucial role in the development of colorectal cancer, with excessive fat intake identified as a major risk factor, suggesting that reducing fat consumption could significantly lower cancer incidence.

Certain types of fiber, particularly from whole grains and fruits and vegetables high in uronic acid, along with specific micronutrients and chemicals, have been shown to inhibit cancer development, indicating the need for more detailed dietary guidelines to further reduce colorectal cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospects for the prevention of colorectal cancer. Nigro, ND., Bull, AW.[2019]

Chemopreventive strategies, including drugs like aspirin and vitamins such as folate, are being developed to prevent colorectal cancer, with ongoing studies using preneoplastic markers to assess their effectiveness.

Diet plays a significant role in colorectal cancer risk, with evidence suggesting that high-fiber, low-fat diets may help prevent the disease, supported by international studies on dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemo- and dietary prevention of colorectal cancer. Schatzkin, A., Kelloff, G.[2019]

In a study of 216 colorectal cancer patients and their family caregivers, patients were less likely to maintain healthy eating habits if they faced perceived barriers to following dietary guidelines.

Patients were more likely to adopt healthier eating habits when their family caregivers actively tried to improve their own dietary habits, suggesting that family involvement is crucial in supporting dietary changes for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and Barriers to Adoption of a Healthy Diet in Survivors of Colorectal Cancer. Lee, MK., Park, SY., Choi, GS.[2020]

Following the DASH diet, which is rich in fiber, nutrients, and antioxidants, is linked to a lower prevalence of various cancers, suggesting it may have protective effects against cancer development.

While this review indicates a positive association between the DASH diet and cancer prevention, further longitudinal studies are needed to clarify the exact relationship due to the complex interactions among different foods and nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary approach to stop hypertension (DASH): diet components may be related to lower prevalence of different kinds of cancer: A review on the related documents. Onvani, S., Haghighatdoost, F., Azadbakht, L.[2020]

A study involving 30 colorectal cancer patients in Auckland revealed that many did not meet the Ministry of Health's dietary guidelines for fruit and vegetable intake, with only 67% and 50% meeting the recommended servings, respectively.

Over 50% of participants reported not receiving any dietary information after their surgery, indicating a significant unmet need for dietary guidance in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and information needs of colorectal cancer patients post-surgery in Auckland. Cha, R., Murray, MJ., Thompson, J., et al.[2016]

A review of 32 studies found that healthy dietary patterns, such as those rich in fruits, vegetables, and whole grains, are associated with a reduced risk of colorectal cancer, with risk estimates ranging from 0.45 to 0.90.

Conversely, Western dietary patterns high in processed meats and low in fruits and vegetables are linked to an increased risk of colorectal cancer, with risk estimates varying from 1.18 to 11.7.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary patterns and the risk of colorectal cancer and adenomas. Randi, G., Edefonti, V., Ferraroni, M., et al.[2022]

In a study of 528 Palestinian adults, higher intakes of dietary fiber were associated with a significantly reduced risk of colorectal cancer (CRC), with an odds ratio of 0.36, indicating a strong protective effect.

Similarly, increased consumption of fruits and vegetables also correlated with a lower CRC risk, showing an odds ratio of 0.34, suggesting that both dietary factors could be important in developing prevention strategies for CRC in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case-Control Study Examining the Association of Fiber, Fruit, and Vegetable Intake and the Risk of Colorectal Cancer in a Palestinian Population. Taha, HM., Slade, AN., Schwartz, B., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05396846

Study Details | NCT05396846 | My Best GI Eating Study The main outcome is to evaluate to what extent these methods improve eating and possibly achieve weight loss over the year of study. Official Title. MyGI Diet ...

2. facingourrisk.org facingourrisk.org/research-clinical-trials/study/258/my-best-gi-eating-study

My Best GI Eating Study : prevention_detection_risk This study will test three different diets in people who are overweight and who have an increased risk of colorectal cancer.

3. cancer.gov cancer.gov/clinicaltrials/NCI-2023-05977

MyBestGI App for the Reduction of Colorectal Cancer Risk The three eating plans being tested in this study all focus on improving food choices consistent with the recommendations for cancer prevention, and this might ...

4. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA255743

MyGI Diet for Colorectal Cancer Prevention This proposal seeks to test two dietary interventions in overweight and obese persons who have a strong family history of CRC or a personal history of CRC.

5. courses.lsa.umich.edu courses.lsa.umich.edu/urop-symposium-2024/symposium-presentati/the-mybestgi-study-for-prevention-of-colorectal-cancer-study-recruitment-and-qualitative-analysis-of-the-intervention-4/

The MyBestGI Study for Prevention of Colorectal Cancer Participants assigned to Eating Plans 2 and 3 receive support calls, text messages, user manuals, and the MyBestGI app for monitoring progress toward their diet ...

6. reporter.nih.gov reporter.nih.gov/project-details/10925164

MyGI Diet for Colorectal Cancer Prevention - NIH RePORTER Building on our previous trials, this proposal seeks to test two dietary interventions in overweight and obese persons who have a strong family history of CRC ...

7. withpower.com withpower.com/trial/phase-colorectal-neoplasms-9-2022-6cadc

Diet Intervention for Colorectal Cancer Prevention Group II: Eating Plan 2Experimental Treatment1 Intervention. This group will receive the MyBestGI App and User Manual that encourages limiting four food ...