Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

Last updated: July 15, 2025
Sponsor: Abramson Cancer Center at Penn Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

R-1,3-Butanediol

Clinical Study ID

NCT05338307
UPCC 01222
IRB 850567
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age of 18 years or older

  • Scheduled for a colonoscopy or flexible sigmoidoscopy as part of the patient'sstandard care

  • Can provide informed consent

Exclusion

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 periodof 16 hours or more per day that is not associated with a medical procedure) duringthe 4 weeks prior to enrollment

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: R-1,3-Butanediol
Phase:
Study Start date:
May 13, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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