Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

Colorectal Cancer Clinical Trial

— BHB-CRC  

Official title:

Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338307
• Other study ID #: UPCC 01222
• Secondary ID: IRB 850567
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• R-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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether oral BHB supplementation is safe and tolerable	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.	Through study completion, which will be approximately 2 years
Secondary	Determine whether oral BHB supplementations increases serum BHB levels	Assessment of fasting serum BHB levels before, during, and after BHB supplementation to determine if BHB supplementation appreciably increases serum BHB levels.	Through study completion, which will be approximately 2 years
Secondary	Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa	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.	Through study completion, which will be approximately 2 years