Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Other Dietary Supplements

All Drugs and Chemicals

Herbal and Botanical

Omega 3 Fatty Acid

Orange

Olive

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.

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.

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.

The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.

Eating Plan 1

Eating Plan 2

Eating Plan 3

Rob Adwere-Boamah, MA

Rob Adwere-Boamah, M.A.

Study Chair

Zora Djuric, PhD

Lorraine Buis, PhD

Ananda Sen, PhD

Michelle Segar, PhD

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.

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. The MyBestGI 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 MyBestGI 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.

The MyBestGI 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 MyBestGI app. The main outcome is to evaluate to what extent these methods improve eating and possibly achieve weight loss over the year of study.

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.

All data and samples will be identified by a participant ID number and visit number. Results will be unblinded with regard to study arm assignment during statistical analysis only.

My Best GI Eating Study

MyGI Diet for Colorectal Cancer Prevention

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
My Best GI Eating Study	NCT05396846	Colorectal Neop...	Eating Plan 1 Eating Plan 2 Eating Plan 3	19 Years -	University of Michigan
My Best GI Eating Study	NCT05396846	Colorectal Neop...	Eating Plan 1 Eating Plan 2 Eating Plan 3	19 Years -	University of Michigan

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