Colorectal Cancer
Conditions
Brief summary
The aim of this study is to assess the feasibility of beta-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy.
Detailed description
The aim of this study is to assess the feasibility of β-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy in order to determine whether BHB supplementation is safe and tolerable. Additionally, this study will determine whether BHB supplementations increases serum BHB levels, and leads to transcription and protein expression changes in the colonic mucosa. BHB supplementation will be performed through oral administration of HVMN Ketone-IQ, a commercially available BHB supplement, with an active ingredient of R-1,3-Butanediol, which gets converted to BHB.
Interventions
DIETARY_SUPPLEMENTR-1,3-Butanediol
Study participants will be taking 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol.
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether oral BHB supplementation is safe and tolerable | Through study completion, which will be approximately 2 years | Assessment of patient tolerance of BHB supplements through weekly monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue through Visit 2, and the percentage continuing through Visit 3, as well as the compliance with taking the BHB supplement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether oral BHB supplementations increases serum BHB levels | Through study completion, which will be approximately 2 years | Assessment of fasting serum BHB levels before, during, and after BHB supplementation to determine if BHB supplementation appreciably increases serum BHB levels. |
| Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa | Through study completion, which will be approximately 2 years | Comparison of both transcription and protein changes in the colonic mucosa from mucosal biopsies before and after BHB supplementation to determine if BHB supplementation is having measurable effects on the colonic mucosa. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBryson W Katona, MD, PhD
University of Pennsylvania
Outcome results
None listed