← Back to Search

Ketone Body Supplement

Ketone Supplement for Colorectal Cancer Prevention (BHB-CRC Trial)

N/A
Waitlist Available
Led By Bryson W Katona, MD, PhD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 18 years or older
Be older than 18 years old
Must not have
History of inflammatory bowel disease
History of diabetes mellitus and currently on medical diabetes therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, which will be approximately 2 years
Awards & highlights

Summary

This trial is testing whether a ketone supplement can help people undergoing a standard colonoscopy or sigmoidoscopy.

Who is the study for?
This trial is for adults over 18 who can consent and are scheduled for a standard colonoscopy or flexible sigmoidoscopy. It's not suitable for those with diabetes on medication, severe kidney disease, active cancer treatment, pregnancy, incarceration, under 18s, history of bowel diseases or recent fasting diets.Check my eligibility
What is being tested?
The study tests if taking β-hydroxybutyrate (BHB) supplement is feasible for people getting routine colon checks. BHB is thought to help in preventing colorectal cancer.See study design
What are the potential side effects?
Potential side effects of BHB supplementation may include gastrointestinal discomfort such as nausea or stomach pain. Since this is an initial investigation, other unexpected side effects might be observed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of inflammatory bowel disease.
Select...
I have diabetes and am currently receiving treatment for it.
Select...
I am currently undergoing treatment for my cancer.
Select...
I cannot have a colonoscopy or flexible sigmoidoscopy.
Select...
I have had surgery to remove my colon and rectum.
Select...
I am not pregnant, imprisoned, or under 18.
Select...
My kidney function is reduced with an eGFR below 60.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, which will be approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, which will be approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine whether oral BHB supplementation is safe and tolerable
Secondary outcome measures
Determine whether oral BHB supplementations increases serum BHB levels
Investigate whether oral BHB supplementation leads to transcription and protein expression changes in the colonic mucosa

Trial Design

1Treatment groups
Experimental Treatment
Group I: BHB supplementationExperimental Treatment1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, targeted therapy, immunotherapy, and emerging treatments like Beta-hydroxybutyrate (BHB) supplementation. Chemotherapy works by killing rapidly dividing cancer cells, while targeted therapy focuses on specific molecular targets involved in cancer growth and progression. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. BHB supplementation, an alternative energy source, impacts metabolic processes and inflammation, potentially inhibiting cancer cell growth and improving patient outcomes. Understanding these mechanisms helps tailor treatments to individual patient needs, improving efficacy and reducing side effects.
Effects of Intestinal Microbial⁻Elaborated Butyrate on Oncogenic Signaling Pathways.The enhancement of phase 2 enzyme activities by sodium butyrate in normal intestinal epithelial cells is associated with Nrf2 and p53.

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,901 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
396 Previous Clinical Trials
147,946 Total Patients Enrolled
Bryson W Katona, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Colorectal Cancer Clinical Trial 2023: R-1,3-Butanediol Highlights & Side Effects. Trial Name: NCT05338307 — N/A
~6 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top