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Dietary Supplement

Part A - 20 grams for Adenomatous Polyposis (BHB-FAP Trial)

N/A
Waitlist Available
Led By Bryson W Katona, MD, PhD
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part A
* Have a diagnosis of FAP with genetic testing demonstrating a pathogenic or likely pathogenic germline variant in APC, must have a clinical FAP phenotype with at least one member of the family who has a pathogenic or likely pathogenic germline variant in APC, or must have a clinical diagnosis of FAP as agreed by two gastrointestinal cancer genetics experts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, which will be approximately 3 years
Awards & highlights

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 reducing the need for frequent upper endoscopies and colonoscopies, and potentially preventing the need for risk-reducing surgical intervention.

Eligible Conditions
  • Adenomatous Polyposis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, which will be approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, which will be approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine whether oral BHB supplementation is safe and tolerable in FAP
Secondary study objectives
Change in transcription and protein expression in the intestinal mucosa and in intestinal polyps in FAP after oral BHB supplementation
Determine whether oral BHB supplementation in FAP reduces intestinal polyp burden
Measure whether oral BHB supplementations increases serum BHB levels in FAP

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B - 20 gramsExperimental Treatment1 Intervention
Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth twice per day (20 total grams of R-1,3-Butanediol) for 12 weeks
Group II: Part B - 10 gramsExperimental Treatment1 Intervention
Study participants will take one 35mL dose of HVMN Ketone-IQ by mouth per day along with one 35mL dose of placebo ketone drink by mouth per day (10 total grams of R-1,3-Butanediol) for 12 weeks
Group III: Part A - 30 gramsExperimental Treatment1 Intervention
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
Group IV: Part A - 20 gramsExperimental Treatment1 Intervention
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
Group V: Part A - 10 gramsExperimental Treatment1 Intervention
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
Group VI: Part B - PlaceboPlacebo Group1 Intervention
Study participants will take one 35mL dose of placebo ketone drink by mouth twice daily for 12 weeks

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor
397 Previous Clinical Trials
147,966 Total Patients Enrolled
The V Foundation for Cancer ResearchOTHER
19 Previous Clinical Trials
1,267 Total Patients Enrolled
Bryson W Katona, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
120 Total Patients Enrolled
~20 spots leftby Oct 2027
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