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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

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : May 13, 2022
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05338307


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
Investigators
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Principal Investigator: Bryson W Katona, MD, PhD University of Pennsylvania
More Information
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Responsible Party: Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT05338307    
Other Study ID Numbers: UPCC 01222
IRB 850567 ( Other Identifier: University of Pennsylvania Abramson Cancer Center )
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases