What is the MEAL Study?
The Men's Eating and Living (MEAL) Study is a clinical trial designed by James Marshall, PhD, James Mohler, MD, and Kelly Parsons, MD. The study aims to explore and understand the correlation between the dietary practices of men and prostate cancer.
Research has shown that a diet high in plant products (e.g., fruits, vegetables, grains) may help decrease the risk of prostate cancer, whereas a diet high in animal products (e.g., meat, dairy) is associated with an increased risk. These diets may also be similarly associated with the overall course of prostate cancer. Strong evidence is needed to reinforce our suspicions. As a result, this clinical trial was created to help us evaluate whether diet actually affects the course of early prostate cancer.
How Does the MEAL Study Work?
Men who are interested in participating must first meet a set of eligibility requirements. If determined eligible, participants will be randomly placed in either a dietary change group or a comparison group.
Dietary Change Group
- Participants will be counseled over the telephone by a nutritionist located at our counseling center at the University of California, San Diego.
- The nutritionist will assist participants in changing their diets to include more plant products and less animal products.
- The researchers will examine whether this change in dietary practice has any effect on the progress of prostate cancer.
- Comparison participants will receive a copy of the Food and Drug Administration Diet Guidelines for Americans.
- Comparison participants will receive eight newsletters containing information about diet and healthy living.
Participants in both groups will be studied and closely monitored for 24 months. Their prostate-specific antigen (PSA) levels will be checked every three months and they will undergo a digital rectal exam at 12 and 24 months. Any progress made through dietary changes will be assessed as a result of blood samples collected at 12 and 24 months. Additionally, participants will complete quality of life questionnaires every six months.
Whether the intervention is successful or not will be determined by changes in the PSA, and by the results of the prostate biopsies conducted at 12 and 24 months. These measures will help the researchers to understand whether the prostate cancer is getting worse.
More About the MEAL Study
If you are interested in participating, please complete the online MEAL Study questionnaire and you will be contacted by a recruiter. The study is presently open through the National Cancer Institute Clinical Trials Program. Patients can enroll at any of over 100 clinical trial sites throughout the U.S.
To learn more about the MEAL Study, watch Dr. Marshall's video post at RPCI's Cancer Talk blog. Further information can be found at ClinicalTrials.gov. Information about other clinical trials at RPCI is also available.