Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

NCT05338307 | Active Not Recruiting

• 2 other identifiers: UPCC 01222IRB 850567
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine whether oral BHB supplementations 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

  Through study completion, which will be approximately 2 years

Study Arms (1)

BHB supplementation

EXPERIMENTAL

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

Interventions

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.

BHB supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

beta-hydroxybutyrate-1,3-butanediol monoester

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bryson W Katona, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 21, 2022
• Study Start: May 13, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)