Study of Oral -Hydroxybutyrate Supplement to Prevent Intestinal Polyps in Familial Adenomatous Polyposis

What this Trial Is About

Researchers are evaluating the potential of beta-hydroxybutyrate BHB supplementation as a new way to slow the growth and development of intestinal adenomas in people with Familial Adenomatous Polyposis FAP. This condition leads to numerous polyps in the intestines, increasing the risk of cancer. The study aims to reduce the need for frequent invasive procedures like upper endoscopies and colonoscopies, as well as prevent surgeries that lower cancer risk. The study includes two parts Part A involves up to 9 participants with FAP taking different doses of an oral BHB precursor called R-1,3-butanediol HVMN Ketone-IQ over two weeks. Part B is a longer open-label study involving up to 20 participants who will undergo colonoscopy or sigmoidoscopy and upper endoscopy before starting daily BHB supplementation for 12 weeks, with a possible 12-week extension. Doses vary from one to three 35mL oral doses daily, delivering 10 to 30 grams of R-1,3-butanediol. Participants will have blood and stool samples collected at multiple points, including before and during treatment, to measure ketone levels and biological changes. Colonoscopies and upper endoscopies are performed at the start, after 12 weeks, and after 24 weeks if participants continue in the extension. The study will assess safety, tolerability, changes in ketone levels, intestinal mucosa and polyp characteristics, and changes in polyp burden over approximately three years.

Investigation of β-hydroxybutyrate Supplementation as Chemoprevention in Familial Adenomatous Polyposis