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

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05338307

Collaborator

(none)

Enrollment

Location

Arm

24.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Dietary Supplement: R-1,3-Butanediol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer

Actual Study Start Date :

Apr 19, 2022

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

Determine whether oral BHB supplementation is safe and tolerable [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 Outcome Measures

Determine whether oral BHB supplementations increases serum BHB levels [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.
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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Bryson W Katona, MD, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05338307

Other Study ID Numbers:

IRB 850567
UPCC 01222

First Posted:

Apr 21, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of May 2, 2022