COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

NCT05692024 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 23-061R01CA263776
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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; Stenosis; Fibrosis, Liver; Ultrasound Elastography; Proton Magnetic Resonance Spectroscopy; Gastrointestinal Microbiome

Keywords

Liver fat; Gut microbiome; Colorectal cancer; Coffee; Tumor biopsy

Outcome Measures

Primary Outcomes (1)

• Change in hepatic fat fraction.

  This will be assessed by proton magnetic resonance spectroscopy (1H-MRS) at randomization and the end of the intervention: The investigators will assess the treatment effect using linear mixed effects model that includes time, group assignment, and the group-by-time interaction as the primary independent variables.

  2 years after study completion

Secondary Outcomes (1)

• Change in liver fibrosis assessment and plasma levels of liver enzymes

  2 years after study completion

Other Outcomes (3)

• Change in the stool microbiome

  2 years after study completion

• ctDNA analysis

  2 years after study completion

• Change in stool metabolomics

  2 years after study completion

Study Arms (2)

Coffee

ACTIVE COMPARATOR

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.

Drug: Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule. DRUG

Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.

Coffee

Placebo DRUG

Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study:
• Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago.
• Age 18 years or older.
• This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.
• The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Subjects must be able and willing to follow study procedures and instructions.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Participants who are receiving any other investigational agents.
• Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
• Regularly consuming more than 2 cups of coffee ( 8 oz) per day for at least 3 days a week in the past month.
• Current or recent use (within 1 month) of any coffee supplements (e.g., green coffee extracts).
• History of diagnosed conditions that may be worsen by coffee, including arrhythmias, insomnia, tremors, tics, generalized anxiety disorder, bipolar disease, panic attacks, Tourette's, epilepsy or overactive bladder.
• History of adverse reactions to coffee or intolerance of coffee consumption.
• Inability or unwillingness to swallow capsules.
• History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications.
• Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
• Pregnant or breastfeeding. The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with coffee. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.
• Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.
• Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Constriction, Pathologic; Liver Cirrhosis; Fatty Liver

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Liver Diseases; Fibrosis; Pathologic Processes

Study Officials

• Aparna R Parikh, MD, MS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyang Song, MD, ScD

CONTACT

(617) 643-3364; msong2@mgh.harvard.edu

Aparna R Parikh, MD, MS

CONTACT

(617) 726-4000; APARNA.PARIKH@MGH.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 20, 2023
• Study Start: March 21, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)