This phase II pilot trial studies the effect of the consumption of foods made with resistant starch compared to foods made with corn starch on biomarkers that may be related to colorectal cancer progression in stage I-III colorectal cancer survivors. Foods made with resistant starch may beneficially influence markers of inflammation, insulin resistance, and the composition of gut bacteria in colorectal cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03781778.
PRIMARY OBJECTIVE:
I. To determine the feasibility of an 8-week dietary intervention testing foods made with resistant starch compared to foods made with corn starch in patients who have completed treatment for stage I-III colorectal cancer.
SECONDARY OBJECTIVES:
I. To assess variability from baseline to 8 weeks in circulating markers of insulin resistance (glucose, insulin and homeostasis model of assessment-insulin resistance [HOMA-IR]) and inflammation (C-reactive protein [CRP], albumin, adiponectin), by randomization arm.
II. To assess variability from baseline to 2 weeks and 8 weeks in gut microbial communities based on 16S ribosomal ribonucleic acid (rRNA) gene sequencing, by randomization arm.
III. To explore whether resistant starch suppresses adenomas/carcinomas in human to mouse fecal microbiota transplantation (FMT) studies.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I (ACTIVE GROUP): Participants eat a diet consisting of resistant starch foods daily for 8 weeks. Study foods are in addition to their own usual daily diet.
GROUP II (CONTROL GROUP): Participants eat a diet consisting of regular corn starch foods daily for 8 weeks. Study foods are in addition to their own usual daily diet.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorMarian Louise Stone Neuhouser
