Colon Cancer Clinical Trial

Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

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.

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Full 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.

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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

Study is for people with:

Colon Cancer

Estimated Enrollment:

20

Study ID:

NCT05338307

Recruitment Status:

Active, not recruiting

Sponsor:

Abramson Cancer Center at Penn Medicine

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There is 1 Location for this study

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Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

20

Study ID:

NCT05338307

Recruitment Status:

Active, not recruiting

Sponsor:


Abramson Cancer Center at Penn Medicine

How clear is this clinincal trial information?

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