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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05338307
Recruitment Status : Active, not recruiting
First Posted : April 21, 2022
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Tracking Information
First Submitted Date  ICMJE April 14, 2022
First Posted Date  ICMJE April 21, 2022
Last Update Posted Date March 15, 2024
Actual Study Start Date  ICMJE May 13, 2022
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2022)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2022)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention
Official Title  ICMJE Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: R-1,3-Butanediol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2022)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05338307
Other Study ID Numbers  ICMJE UPCC 01222
IRB 850567 ( Other Identifier: University of Pennsylvania Abramson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abramson Cancer Center at Penn Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abramson Cancer Center at Penn Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bryson W Katona, MD, PhD University of Pennsylvania
PRS Account Abramson Cancer Center at Penn Medicine
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP