Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention (BHB-CRC)
Primary Purpose
Colorectal Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
R-1,3-Butanediol
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BHB supplementation
Arm Description
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, for a total of 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05338307
First Posted
April 14, 2022
Last Updated
April 25, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05338307
Brief Title
Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention
Acronym
BHB-CRC
Official Title
Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BHB supplementation
Arm Type
Experimental
Arm Description
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, for a total of 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
R-1,3-Butanediol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine whether oral BHB supplementation is safe and tolerable
Description
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.
Time Frame
Through study completion, which will be approximately 2 years
Secondary Outcome Measure Information:
Title
Determine whether oral BHB supplementations increases serum BHB levels
Description
Assessment of fasting serum BHB levels before, during, and after BHB supplementation to determine if BHB supplementation appreciably increases serum BHB levels.
Time Frame
Through study completion, which will be approximately 2 years
Title
Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa
Description
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.
Time Frame
Through study completion, which will be approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryson W Katona, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention
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