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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05338307|
Recruitment Status : Recruiting
First Posted : April 21, 2022
Last Update Posted : May 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Dietary Supplement: R-1,3-Butanediol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer|
|Actual Study Start Date :||April 19, 2022|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||April 30, 2024|
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.
- 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.
- 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.
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
|Contact: Bryson W Katona, MD, PhDemail@example.com|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Bryson W Katona, MD, PhD 215-349-8222 firstname.lastname@example.org|
|Principal Investigator:||Bryson W Katona, MD, PhD||University of Pennsylvania|