Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention (BHB-CRC)

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: R-1,3-Butanediol

Study type: Interventional

Funder types: Other

Identifiers

NCT05338307

UPCC 01222 (Other Identifier)

IRB 850567

Details and patient eligibility

About

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.

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

BHB supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: R-1,3-Butanediol