Study of Daily Coffee Capsule Use to Reduce Liver Fat and Improve Gut Health in Adults Treated for Stage I-III Colorectal Cancer

What this Trial Is About

Researchers are evaluating the effects of daily use of freeze-dried instant coffee on liver fat, liver fibrosis, and the gut microbiome in patients who have completed standard treatments for stage I-III colorectal cancer. This clinical trial aims to understand how coffee influences these factors and whether it may have a role in chemoprevention for colorectal cancer survivors. The study is designed to test the safety and effectiveness of this investigational intervention. Participants are randomly assigned to one of two groups one group receives capsules containing Nestl NESCAF TASTERS CHOICE House Blend coffee, equivalent to three cups daily, while the other group receives placebo capsules with similar appearance and flavor but without coffee. The treatment period lasts between 8 and 12 weeks. The coffee or placebo capsules are mailed to participants, who take 15 capsules daily during the study. During the study, participants attend two visits for assessments including proton magnetic resonance spectroscopy, magnetic resonance imaging, and ultrasound elastography. Researchers collect urine, blood, and stool samples, along with diet and lifestyle questionnaires and archival tumor biopsy tissue. The main outcome measured is the change in liver fat fraction, assessed two years after study completion, along with liver fibrosis and liver enzyme levels. The total participation includes screening, treatment, and long-term follow-up to monitor these outcomes.

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER