Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention

NCT ID: NCT05338307

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2026-06-30

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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BHB supplementation

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.

Group Type: EXPERIMENTAL

R-1,3-Butanediol

Intervention Type: 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.

Interventions

R-1,3-Butanediol

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryson W Katona, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB 850567

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 01222

Identifier Type: -

Identifier Source: org_study_id