BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital
About this trial
This research study is a prospective, single-arm clinical trial to assess the effect of a dietary intervention for more plant-based and less animal-based food intake on secondary bile acid production, gut microbiota, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Underwent screening or surveillance colonoscopy with removal of at least one adenoma.
Age 18-80 years.
Habitually consume a Western pattern diet.
BMI of at least 18.5 kg/m2 but less than 35 kg/m2
Disqualifiers
Strict dietary patterns (e.g., vegan, carnivore, kosher, low-carb etc.).
Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis.
Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years.
Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome).
Trial design
Design model
Single group
Treatments tested in this trial
Increased Plant-Based Diet and Decreased Animal-Based Diet
BehavioralSelf-regulated diet; increased plant-based foods with decreased animal-based foods
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Increased Plant-Based Diet and Decreased Animal-Based DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Stool Metabolomics
Comparing change in stool metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
Time frame
From Baseline to Final Visit (5 weeks)Secondary outcomes
1
Relative Composition of Gut Microbiome
Comparing change in gut microbiome features (species - to strain level specificity; metabolic pathways; enzymes) and metabolites using deep meta'omic profiling in pre- and post- treatment samples.
Time frame
From Baseline to Final Visit (5 weeks)Other outcomes
1
Change in Plasma Bile Acid Metabolomics
Comparing change in plasma bile acid metabolomics, using non-targeted global metabolomics analysis on stool samples to examine intensity changes in the stool metabolite profile.
Time frame
From Baseline to Final Visit (5 weeks)2
Relative Composition of Circulating Biomarkers
The investigators will use plasma collected in EDTA tubes and processed within 2-4 hours of collection to measure circulating protein biomarkers associated with bile acid receptor activity, including plasma concentrations of 92 inflammation-related proteins measured using the proximity extension immunoassay \[PEA\] technology \[Olink Proteomics®, Uppsala, Sweden\] with the ProSeek Multiplex Inflammation panel (Olink® target 92 inflammation panel). These measurements will be performed on samples collected at the initial and final visits to evaluate diet-induced changes in bile acid signaling.
Time frame
From Baseline to Final Visit (5 weeks)3
Relative Composition of Circulating Gene Expression Profile
The investigators will use plasma collected in EDTA tubes and processed within 2-4 hours of collection to measure circulating biomarkers associated with colorectal tumorigenesis using validated enzyme-linked immunosorbent assay (ELISA) kits, including BIRC5 (survivin), FOXM1, MYC, IL6, TNF, and S100A8/A9. These measurements will be performed on samples collected at the initial and final visits to evaluate diet-induced changes in systemic inflammation.
Time frame
From Baseline to Final Visit (5 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov