This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.
This research study is a chemoprevention clinical trial, designed to test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the drug is being studied. The investigators plan to recruit 80 participants. * Coffee is a complex mixture of hundreds of bioactive compounds, including caffeine, chlorogenic acids, and other polyphenols. Increasing data suggest the anti-cancer benefit of coffee. Observational data have linked coffee drinking to better survival among patients with colorectal cancer. However, there remains uncertainty surrounding the mode of action. * The U.S. Food and Drug Administration (FDA) has not approved coffee as a treatment for any disease. * The research study procedures include: * Screening for eligibility. * Two study visits * Proton magnetic resonance spectroscopy. * Magnetic resonance imaging * Ultrasound elastography. * Urine, blood, and stool samples collected. * Diet and lifestyle questionnaires * Collection of archival tumor biopsy tissue. * Treatment: Coffee or placebo administered daily, orally for 8-12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.
Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGChange in hepatic fat fraction.
This will be assessed by proton magnetic resonance spectroscopy (1H-MRS) at randomization and the end of the intervention: The investigators will assess the treatment effect using linear mixed effects model that includes time, group assignment, and the group-by-time interaction as the primary independent variables.
Time frame: 2 years after study completion
Change in liver fibrosis assessment and plasma levels of liver enzymes
This will be analyzed including the score assessed by the FibroScan® system, plasma liver enzymes, and fibrosis-4 index, at randomization and the end of the intervention: The investigators will assess the treatment effect using linear mixed effects model that includes time, group assignment, and the group-by-time interaction as the primary independent variables.
Time frame: 2 years after study completion
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