Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: R-1,3-Butanediol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BHB supplementation<br>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. | Dietary Supplement: R-1,3-Butanediol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |