Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

N/AActive Not RecruitingNCT05338307

Abramson Cancer Center at Penn Medicine20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

R-1,3-ButanediolDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, which will be approximately 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, which will be approximately 2 years

Data from ClinicalTrials.gov

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