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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06578637
Status
Recruiting
Apply to this trial

Conditions

  • FAP
  • Familial Adenomatous Polyposis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • R-1,3-Butanediol (10G-A) — DIETARY_SUPPLEMENT
    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
  • R-1,3-Butanediol (20G-A) — DIETARY_SUPPLEMENT
    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
  • R-1,3-Butanediol (30G-A) — DIETARY_SUPPLEMENT
    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
  • R-1,3-Butanediol (30G-B) — DIETARY_SUPPLEMENT
    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

Study Details

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.

Key Dates

Start date
Sep 20, 2024
Status verified
Aug 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Part A - 10 grams
    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
  • Experimental: Part A - 20 grams
    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
  • Experimental: Part A - 30 grams
    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
  • Experimental: Part B - 30 grams
    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

Primary Outcome Measure

Determine whether oral BHB supplementation is safe and tolerable in FAP [ Time Frame: Through study completion, which will be approximately 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Bryson W Katona, MD, PhD
[email protected]
215-349-8222
Bryson W Katona, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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