Dietary Supplement (HVMN Ketone-IQ) for the Prevention of the Development and Progression of Intestinal Adenomas in Patients with Familial Adenomatous Polyposis, BHB-FAP Trial
This phase II trial tests the safety, side effects, best dose and effectiveness of a dietary supplement, HVMN Ketone-IQ, in preventing the development and progression of intestinal growths (adenomas, or polyps) in patients with familial adenomatous polyposis (FAP). FAP is the most common hereditary colonic polyposis syndrome. Individuals with FAP develop many colon polyps over their lifetime. These polyps can turn into colorectal cancer if not removed. Therefore, individuals with FAP undergo frequent colonoscopies or sigmoidoscopies and often have preventive surgeries where part of the colon is removed. Additionally, individuals with FAP develop polyps in their small intestine, especially in the beginning of the small intestine, an area called the duodenum. These duodenal polyps can turn into duodenal cancer if not removed. Finding methods to decrease the growth of polyps throughout the intestine (both in the duodenum, small intestine, and colon) would be important for individuals with FAP as it may decrease the need for colonoscopy/sigmoidoscopy or upper endoscopy, decrease the need for preventive surgery to remove part of the colon, and decrease colorectal and duodenal cancer risk. Recent research has shown that a natural metabolite called β-hydroxybutyrate (BHB) may reduce risk of developing colorectal polyps and colorectal cancer. β-hydroxybutyrate is generated when the body is fasting or if an individual is on a ketogenic diet, which is a diet that is high in fat and low in carbohydrates. Supplementation with HVMN Ketone-IQ may be able to increase levels of β-hydroxybutyrate, which may be safe and effective in reducing the risk of developing colorectal polyps and colorectal cancer.