NCT05692024

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.

Detailed 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. * 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.

Conditions

• Colorectal Cancer
• Coffee
• Gastrointestinal Microbiome
• Stenosis
• Fibrosis, Liver
• Ultrasound Elastography
• Proton Magnetic Resonance Spectroscopy

Interventions

Type	Name	Description
DRUG	Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.	Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.
DRUG	Placebo	Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.

Timeline

• Start date: 2024-03-21
• Primary completion: 2026-12-31
• Completion: 2027-12-01
• First posted: 2023-01-20
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study