A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.
Must have histologically or cytologically confirmed colorectal adenocarcinoma.
Planned for primary tumor resection at the University of Chicago Medicine ≥21 from date of obtained informed consent. Patients with metastatic disease but undergoing primary site resection are eligible for the study.
Age ≥18 years.
Patients <18 years of age, children are excluded from this study, because they have unique nutritional requirements that might not be met by with the standardized diet. The food in the diet is designed for adults and would not be feasible for children, especially those attending school. In addition, colon cancer is extremely rare in children.
Previous ostomy (ileostomy or colostomy) or definitive plan for an ostomy (ileostomy or colostomy) during the procedure.
Antibiotic exposure within 60 days before diet initiation. Antibiotic exposure is defined as a 'course of treatment to treat an infection'. Prophylactic antibiotics prior to a procedure is okay.
Prebiotic/Probiotic exposure within 60 days before diet initiation.
Concomitant separate malignancy.
Single group
High-fiber/low-fat meals
Dietary supplementMeals with Low fat/High fiber
Change in lab values of the dietary intervention on the collagenolytic potential of the microenvironment.
To assess whether the dietary intervention significantly changed the collagenase activity, the site will compare each subject's baseline and final values.
Change in stool samples of the dietary intervention on components of the urokinase-type plasminogen activator (uPA) plasminogen system.
The site will compare the presence of active-uPA, active- Matrix metalloproteinase-9 (MMP9), and plasminogen in stool samples before and after diet intervention. These assays will be performed in the Shogan Laboratory using western blot and zymography.
Change in stool samples in the metagenomic response of the gut microbiome to the dietary intervention.
There will be an investigation in the stool associated metagenomics in subjects before and after intervention. During this analysis it will determine the bacterial composition and function, with a particular interest in proteolytic function.
Change in the levels of short-chain fatty acids and bile acids in the metabolomic response to the dietary intervention.
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