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NCT Number: NCT05338307

Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

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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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R-1,3-Butanediol

Dietary 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.

Primary outcomes

  1. Determine whether oral BHB supplementation is safe and tolerable

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

    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 outcomes

  1. Determine whether oral BHB supplementations increases serum BHB levels

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

    Assessment of fasting serum BHB levels before, during, and after BHB supplementation to determine if BHB supplementation appreciably increases serum BHB levels.

  2. Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa

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

    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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer

Acronym: BHB-CRC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2022
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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