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Clinical Trial Summary

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 undergone surgery for stage I or II colon cancer or undergone surgery and completed chemotherapy for stage III colon cancer.

Clinical Trial Description

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. - 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 Design

Related Conditions & MeSH terms

NCT number NCT05692024
Study type Interventional
Source Massachusetts General Hospital
Contact Mingyang Song, MD, ScD
Phone (617) 643-3364
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date June 1, 2023
Completion date June 1, 2027

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