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Coffee and Gut Health in Colorectal Cancer Survivors

This research study is looking at how drinking coffee affects liver fat, liver scarring (fibrosis), and the germs in your gut (gut microbiome) in people who have finished treatment for stage I, II, or III colorectal cancer. You would take either Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsules or a placebo (an inactive capsule that looks like the coffee capsule) every day for 8-12 weeks. Researchers want to see if coffee can help reduce liver fat, which will be measured two years after the study ends. This study is for adults aged 18 and older who have completed their standard colorectal cancer treatment at least two months ago. The study aims to enroll 80 participants.

Study design
This is an interventional study, meaning participants receive a specific treatment. It plans to enroll 80 participants to test the safety and effectiveness of the intervention.
What's involved
You would have two study visits, undergo proton magnetic resonance spectroscopy, MRI, and ultrasound elastography. You would also provide urine, blood, and stool samples, complete diet and lifestyle questionnaires, and allow collection of archival tumor biopsy tissue. You would take coffee or placebo daily for 8-12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your liver fat will be measured two years after the study completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05692024

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

Recruiting
PHASE1Ages 18+InterventionalPrevention
Massachusetts General Hospital
~80 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in hepatic fat fraction.
Measured over 2 years after study completion

Conditions

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

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Aparna R Parikh, MD, MS · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Mingyang Song, MD, ScD
[email protected]
(617) 643-3364
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.

What this trial measures

  • Change in hepatic fat fraction.2 years after study completion

    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.