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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Meals with Low fat/High fiber
University of Chicago
Chicago, Illinois, United States
RECRUITINGChange 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.
Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.
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.
Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.
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.
Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.
Change in the levels of short-chain fatty acids and bile acids in the metabolomic response to the dietary intervention.
Time frame: At baseline on Day 1 until final values collected on 6 months post-op visit.
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