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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The MyBestGI 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 (MyBestGI 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.

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.

What data supports the effectiveness of the treatment Eating Plan 1, Dietary Intervention, Healthy Eating Plan, Eating Plan 2, MyBestGI App and User Manual - Limited Diet Plan, Eating Plan 3, Full Eating Plan, Healthy Eating Plan, Preventive Diet, Self-Guided Eating Plan, MyBestGI App, Self-Guided Eating Plan, Preventive Eating Plan, Simple Eating Plan, MyBestGI App, Preventive Eating Plan, Healthy Eating Plan for colorectal cancer prevention?

Research suggests that continuous nutrition care and adherence to healthy dietary patterns, like the Mediterranean diet, can improve nutritional status and reduce the recurrence of colorectal adenomas, especially in women. Additionally, higher intake of fiber, fruits, and vegetables is associated with a lower risk of colorectal cancer. ^{1 2 3 4 5}

Is the dietary intervention for colorectal cancer prevention safe for humans?

The dietary interventions, including healthy eating patterns with high intake of fruits, vegetables, grains, and lean meats, are generally considered safe for humans and are associated with a reduced risk of colorectal cancer. ^{6 7 8 9 10}

How does the Diet Intervention for Colorectal Cancer Prevention treatment differ from other treatments?

This treatment is unique because it focuses on dietary changes, emphasizing a high intake of fruits, vegetables, whole grains, and low-fat dairy, which are associated with a reduced risk of colorectal cancer. Unlike drug-based chemoprevention, this approach leverages natural food components to potentially lower cancer risk. ^{10 11 12 13 14}

Research Team

Zora Djuric, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Not expecting major lifestyle changes in the next 12 months

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Dietary patterns and the risk of colorectal adenoma recurrence in a European intervention trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Facilitators and Barriers to Adoption of a Healthy Diet in Survivors of Colorectal Cancer. [2020]

3. Korea (South) 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. [2023]

4. United States 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. [2021]

5. Switzerland 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The association of the healthy eating index with risk of colorectal cancers (overall and by subsite) among Canadians. [2023]

7. United States 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. [2021]

8. India 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. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Dietary patterns and information needs of colorectal cancer patients post-surgery in Auckland. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Recent advances in clinical practice: colorectal cancer chemoprevention in the average-risk population. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Prospects for the prevention of colorectal cancer. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Chemo- and dietary prevention of colorectal cancer. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Nutrition and colorectal cancer]. [2017]

14. United States pubmed.ncbi.nlm.nih.gov

Dietary patterns and the risk of colorectal cancer and adenomas. [2022]