Ketone Supplement for Colorectal Cancer Prevention

(BHB-CRC Trial)

BW
Overseen ByBryson W Katona, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abramson Cancer Center of the University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a ketone supplement, specifically beta-hydroxybutyrate (BHB), can help prevent colorectal cancer. Participants will take a liquid form of this supplement, called R-1,3-Butanediol, three times a day for four weeks. The trial targets individuals already scheduled for a colonoscopy or flexible sigmoidoscopy, standard procedures for checking colon health. Suitable candidates should not have certain medical conditions, such as diabetes or chronic kidney disease, and should not follow special diets like the ketogenic diet or intermittent fasting. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on cancer prevention.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have diabetes and are on diabetes medication, you cannot participate in this trial.

What prior data suggests that beta-hydroxybutyrate supplementation is safe?

Research has shown that R-1,3-Butanediol, an ingredient in the ketone supplement under testing, is generally safe for people. Studies indicate it can quickly increase levels of beta-hydroxybutyrate (BHB) in the blood. BHB is a type of ketone produced when fewer carbohydrates are consumed.

In studies where participants took R-1,3-Butanediol, no serious side effects occurred. Some individuals might experience mild stomach discomfort, but many find it manageable. This information is promising for those considering participation in a clinical trial with this supplement.12345

Why are researchers excited about this trial?

Unlike the standard treatments for colorectal cancer, which often involve surgery, chemotherapy, and radiation, the new approach with R-1,3-Butanediol focuses on prevention. This treatment is unique because it uses a ketone supplement, HVMN Ketone-IQ, which introduces R-1,3-Butanediol into the body. Researchers are excited about this because ketones provide an alternative energy source for cells, potentially reducing the growth of cancerous cells by limiting their access to glucose. This novel method could offer a non-invasive preventive strategy, setting it apart from more aggressive traditional treatments.

What evidence suggests that this treatment might be an effective treatment for colorectal cancer prevention?

Research has shown that beta-hydroxybutyrate (BHB), administered in this trial as R-1,3-Butanediol, might lower the risk of colorectal cancer. One study found that BHB treatment alone reduced the number of tumors in the colon. Additionally, BHB slowed the growth of colon cancer cells. Another study suggested that BHB can also slow the spread of abnormal cells in the colon. These findings support the potential of BHB in preventing colorectal cancer.56789

Who Is on the Research Team?

BW

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.
See 4 more

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

Find a Clinic Near You

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+

Citations

β-Hydroxybutyrate suppresses colorectal cancer - PMCStrikingly, the BHB treatment alone led to reduced tumour burden in the colon (Fig. 2j, k and Extended Data Fig. 4a, b). By contrast, butyrate ...
Investigation of β-hydroxybutyrate Supplementation as ...The aim of this study is to evaluate the potential of BHB supplementation as a novel strategy to impede the development and progression of intestinal adenomas ...
β-hydroxybutyrate resensitizes colorectal cancer cells to ...It has been reported that BHB can reduce the proliferation of colonic crypt cells and effectively inhibit intestinal tumor growth (Dmitrieva- ...
Ketogenic diet suppresses colorectal cancer through the ...Results. KD leads to reduced colonic tumor burden and immune inflammatory response in CRC. To study the relevance of the gut microbiome in CRC ...
BHB May Help Prevent Colorectal Cancer - NCIA study in mice suggests that a ketone called BHB can slow the growth of abnormal cells in the colon and colon cancer cells.
Preliminary Investigation of β-hydroxybutyrate ...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 ...
1,3-Butanediol, and Its Acute Effect on ß-Hydroxybutyrate ...Bis-octanoyl-(R)-1,3-butanediol (BO-BD) is a novel ketone ester (KE) ingredient which increases blood beta-hydroxybutyrate (BHB) concentration rapidly after ...
Ketone Supplement for Colorectal Cancer Prevention (BHB ...... R-1,3-Butanediol will have tolerable side effects & efficacy for patients with Colorectal Cancer and Colorectal Cancer. Learn more about the study.
The ketogenic diet modulates tumor-associated neutrophil ...These results suggest that BHB levels could serve as a prognostic biomarker for CRC. In conclusion, our findings indicate that BHB derived from KD regulates ...
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