Clinicaltrials.gov identifier:
NCT05396846
Prevention
Diet and weight loss study for people who are overweight and at increased risk of colorectal cancer
Study Contact Information:
For additional information, please contact: Rob Adwere-Boamah, M.A by phone 734-232-4971 or by email [email protected] or contact the study chair by phone 734-936-4494.
My Best GI Eating Study
About the Study
This study will test three different diets in people who are overweight and who have an increased risk of colorectal cancer. The study will look at whether these diets improve eating and possibly lead to weight loss.
What the Study Involves
Participants will attend study visits in Ann Arbor, Michigan at the start of the study, and at 6 and 12 months. Participants in this study will be randomly divided into three groups. The participant and researchers will not be able to choose which group the participant is in.
Participants will follow one of three eating plans for 12 months:
Group 1 will receive a written pamphlet from the American Institute for Cancer Research about cancer preventative diets.
Group 2 will receive the MyBestGI App and User Manual which will limit the amounts of foods from four groups:
- foods with refined flour
- foods with added sugar
- processed meat
- red meat
They will also be supported by written educational materials and brief telephone support calls.
Group 3 will receive the MyBestGI App and User Manual which will limit the same four food groups as Group 2 as well as encourage seven food groups (fruits, vegetables, herbs, whole grains, foods high in omega-3 fatty acids, olive oil, legumes or nut butter). They will also be supported by written educational materials and brief telephone support calls.
Study Site
Michigan
University of Michigan
Ann Arbor, Michigan
Contact: Rob Adwere-Boamah, M.A. 734-232-4971 [email protected]
Contact: Study Chair 734-936-4494
Individuals ages 19 and older who have:
- A body mass index (BMI) of 25-45 kg/m2 OR waist circumference of greater than 88 cm for women and greater than 102 cm for men
- Stable weight in the last 2 months
- Increased risk of colorectal cancer defined by one or more of the following:
- Prior adenomatous polyp
- Prior surgically removed, early colorectal cancer
- Family history of colorectal cancer
- A known genetic condition that increases risk of colorectal cancer
- Good general health
- Reasonable control over their own diets
- No expected major life changes in the next 12 months
- A smartphone and can be contacted by telephone for support calls
- The ability to follow a diet high in fiber
- Successfully completed three 24-hour dietary recalls before study visit 2
- The ability to follow up with their doctor to manage any medications that might need to be adjusted due to diet changes such as diabetes or high blood pressure medications
Individuals who do not meet the inclusion criteria defined above and those who:
- Have other medically prescribed diets
- Have medical reasons that they cannot follow the study diets
- Are pregnant or lactating or wish to get pregnant during the length of the study
- Take medications that make them unable to give a blood sample such as anti-coagulants
- Have had chemotherapy or radiation for cancer treatment within the last year
- Have an infectious disease