Preliminary Investigation of ß-hydroxybutyrate Supplementation in Colorectal Cancer Prevention
- Conditions
- Colorectal Cancer
- Registration Number
- NCT05338307
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Age of 18 years or older<br><br> - Scheduled for a colonoscopy or flexible sigmoidoscopy as part of the patient's<br> standard care<br><br> - Can provide informed consent<br><br>Exclusion Criteria:<br><br> - Subject is pregnant, a prisoner, or is under 18 years of age<br><br> - Patient is not able to undergo colonoscopy or flexible sigmoidoscopy<br><br> - Prior total proctocolectomy<br><br> - History of inflammatory bowel disease<br><br> - History of diabetes mellitus and are currently on medical diabetes therapy<br><br> - History of chronic kidney disease with an eGFR < 60 mL/min/1.73m2<br><br> - Cancer diagnosis where the subject is receiving active therapy<br><br> - Use of either a ketogenic diet or intermittent fasting (defined as a fasting period<br> of 16 hours or more per day that is not associated with a medical procedure) during<br> the 4 weeks prior to enrollment
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine whether oral BHB supplementation is safe and tolerable
- Secondary Outcome Measures
Name Time Method Determine whether oral BHB supplementations increases serum BHB levels;Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa