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

NCT06578637 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

R-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_SUPPLEMENT

R-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_SUPPLEMENT

R-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_SUPPLEMENT

R-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

Sponsors & Collaborators

  • The V Foundation for Cancer Research

    collaborator OTHER

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Bryson W Katona, MD, PhD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-20
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578637 on ClinicalTrials.gov