Ketone Supplement for Colorectal Cancer Prevention

(BHB-CRC Trial)

Overseen By Bryson W Katona, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Pregnancy, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a BHB supplement, which is a type of ketone used for energy, in patients having a colonoscopy or flexible sigmoidoscopy. The goal is to see if the supplement is safe and if it changes the cells in the colon.

Who Is on the Research Team?

Bryson W Katona, MD, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Can provide informed consent

I am scheduled for a colonoscopy or sigmoidoscopy as part of my routine care.

Exclusion Criteria

I have a history of inflammatory bowel disease.

I have diabetes and am currently receiving treatment for it.

I am currently undergoing treatment for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BHB supplementation through oral administration of HVMN Ketone-IQ for 4 weeks

4 weeks

Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• R-1,3-Butanediol

Trial Overview 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.

How Is the Trial Designed?

Group I: BHB supplementation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+