RecruitingNot ApplicableNCT06578637

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


Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

20 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 in individuals with FAP, thus potentially reducing the need for frequent upper endoscopies and colonoscopies and preventing the need for risk-reducing surgical intervention.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether beta-hydroxybutyrate (BHB) supplements — a compound naturally produced during low-carb or fasting states — can help prevent polyps from growing in people with familial adenomatous polyposis (FAP), a genetic condition that causes many colon polyps and increases cancer risk. **You may be eligible if...** - You have been diagnosed with FAP (a genetic condition causing many colon polyps), confirmed by genetic testing or clinical diagnosis - You have already had a large portion of your colon surgically removed (subtotal colectomy or total colectomy with a pouch) - You still have remaining bowel tissue where polyps can develop (rectum, pouch, or small intestine) **You may NOT be eligible if...** - You have not had the required type of bowel surgery - You have active cancer (not just polyps) - You have serious liver, kidney, or metabolic conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTR-1,3-Butanediol (10G-A)

Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth per day (10 total grams of R-1,3-Butanediol) for 2 weeks

DIETARY_SUPPLEMENTR-1,3-Butanediol (20G-A)

Study participants will take two 35mL dose of HVMN Ketone-IQ by mouth per day (20 total grams of R-1,3-Butanediol) for 2 weeks

DIETARY_SUPPLEMENTR-1,3-Butanediol (30G-A)

Study participants will take three 35mL dose of HVMN Ketone-IQ by mouth per day (30 total grams of R-1,3-Butanediol) for 2 weeks

DIETARY_SUPPLEMENTR-1,3-Butanediol (30G-B)

Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth three times per day (30 total grams of R-1,3-Butanediol) for 12 weeks, with a possible additional 12 week extension


Locations(1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06578637


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