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Could a ketone drink help fight colorectal cancer? a trial investigates

NCT ID NCT05338307

Knowledge-focused Sponsor: Abramson Cancer Center at Penn Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study is testing whether a ketone supplement called beta-hydroxybutyrate (BHB) is safe and tolerable for people scheduled for a colonoscopy or flexible sigmoidoscopy as part of their standard care. Participants will take a drink containing R-1,3-butanediol three times daily for a short period. The main goals are to see if people can stick with the supplement and if it raises BHB levels in the blood, which could inform future research on its potential role in colorectal cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
R-1,3-Butanediol (a ketone supplement)
What this could lead to
If this supplement is well-tolerated and raises blood ketone levels, it could pave the way for larger studies exploring whether ketones might influence colorectal cancer development or progression.
What could go wrong
This is a very small, early feasibility study, not designed to test whether the supplement affects cancer itself. Side effects or poor tolerance could limit its use, and results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age of 18 years or older * Scheduled for a colonoscopy or flexible sigmoidoscopy as part of the patient's standard care * Can provide informed consent Exclusion Criteria: * Subject is pregnant, a prisoner, or is under 18 years of age * Patient is not able to undergo colonoscopy or flexible sigmoidoscopy * Prior total proctocolectomy * History of inflammatory bowel disease * History of diabetes mellitus and are currently on medical diabetes therapy * History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2 * Cancer diagnosis where the subject is receiving active therapy * Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.