Investigating R-1,3-Butanediol for Familial Adenomatous Polyposis (FAP)
This study is looking at whether a dietary supplement called R-1,3-Butanediol (HVMN Ketone-IQ) can help prevent or slow down the growth of polyps in people with Familial Adenomatous Polyposis (FAP). FAP is a genetic condition that causes many polyps to grow in the colon and rectum, increasing cancer risk. Researchers want to see if this supplement is safe and tolerable, and if it can reduce the need for frequent endoscopies and surgeries. To join, you must be 18 or older and have a diagnosis of FAP, confirmed by genetic testing or by two gastrointestinal cancer genetics experts. The study aims to enroll up to 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is an open-label study, so both you and the researchers will know which dose you are receiving. The study plans to enroll up to 20 participants.
- What's involved
- You would take R-1,3-Butanediol (HVMN Ketone-IQ) daily for either 2 weeks or 12 weeks, with a possible 12-week extension. This involves blood draws, stool samples, weekly at-home ketone level checks, and upper endoscopies and colonoscopies/sigmoidoscopies at specific times.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal of the study is to determine safety and tolerability, which will be measured throughout the study completion, approximately 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis
At a glance
Conditions
NCT06578637
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Bryson W Katona, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Determine whether oral BHB supplementation is safe and tolerable in FAPThrough study completion, which will be approximately 3 years
Assessment of FAP patient tolerance of BHB supplements through monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue BHB supplementation for the duration of the study, as well as the compliance with taking the BHB supplement.