COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05692024
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 21, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Coffee
    Participants in the active arm will take 15 capsules of coffee, each of which will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend (equivalent daily dose: three cups of coffee). Participants will receive a twelve-week supply of blinded drug capsules in the mail from Johnson Compounding Pharmacy. The anticipated duration of the study is at least 8 weeks and no more than 12 weeks.
  • Placebo Comparator: Placebo
    Participants in the placebo arm will take 15 capsules of placebo. Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances. Participants will receive a twelve-week supply of blinded drug capsules in the mail from Johnson Compounding Pharmacy. The anticipated duration of the study is at least 8 weeks and no more than 12 weeks.

Primary Outcome Measure

Change in hepatic fat fraction. [ Time Frame: 2 years after study completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02115
Mingyang Song, MD
[email protected]
617-643-4464
Mingyang Song, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
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By specialty
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By research site
Massachusetts General Hospital· Boston, MA

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