COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
NCT05692024 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-05-05
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.
Conditions
- Colorectal Cancer
- Coffee
- Gastrointestinal Microbiome
- Stenosis
- Fibrosis, Liver
- Ultrasound Elastography
- Proton Magnetic Resonance Spectroscopy
Interventions
- DRUG
-
Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.
Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.
- DRUG
-
Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Cancer Institute (NCI)
collaborator NIH -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Aparna R Parikh, MD, MS · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-21
- Primary Completion
- 2028-03-31
- Completion
- 2028-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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