Health TrialsbyHealthPanel

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

ConditionsFAPFamilial Adenomatous Polyposis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Must have an extensive colonic resection with either a subtotal colectomy with ileorectal anastomosis (STC-IRA) or total proctocolectomy with ileal pouch anal anastomosis (TPC-IPAA)

Can provide informed consent

Disqualifiers

Subject is pregnant, a prisoner, or is under 18 years of age

Prior total proctocolectomy with end ileostomy

History of inflammatory bowel disease

History of diabetes mellitus and are currently on medical diabetes therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 4 treatment groups
Group A: Part A - 10 gramsExperimental treatment 1 intervention
Group B: Part A - 20 gramsExperimental treatment 1 intervention
Group C: Part A - 30 gramsExperimental treatment 1 intervention
Group D: Part B - 30 gramsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Determine whether oral BHB supplementation is safe and tolerable in FAP

Assessment of FAP patient tolerance of BHB supplements through monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue BHB supplementation for the duration of the study, as well as the compliance with taking the BHB supplement.

Time frame
Through study completion, which will be approximately 3 years

Secondary outcomes

1

Measure whether oral BHB supplementations increases serum BHB levels in FAP

Measure fasting serum BHB levels before, during, and at the end of BHB supplementation to determine if BHB supplementation significantly increases serum BHB levels.

Time frame
Through study completion, which will be approximately 3 years
2

Change in transcription and protein expression in the intestinal mucosa and in intestinal polyps in FAP after oral BHB supplementation

Transcriptional profiling and subsequent validation with protein level determination will be performed in the intestinal mucosa and in intestinal polyps before and after BHB supplementation to determine if BHB supplementation is having measurable transcriptional and protein effects on the intestinal mucosa and on intestinal polyps.

Time frame
Through study completion, which will be approximately 3 years
3

Determine whether oral BHB supplementation in FAP reduces intestinal polyp burden

The polyp burden in the duodenum as well as in the lower GI tract (rectal cuff, rectum, rectal pouch) will be calculated through polyp counting and measurement on endoscopy before and after BHB supplementation to permit comparison of polyp burden before and after BHB supplementation.

Time frame
Through study completion, which will be approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

The V Foundation for Cancer Research

Collaborator

Source ClinicalTrials.gov
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