Clinical trial · Interventional
Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer Prevention
Preliminary Investigation of β-hydroxybutyrate Supplementation in Colorectal Cancer
NCT05338307CI-TRIAL-00121786BHB-CRCactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to assess the feasibility of beta-hydroxybutyrate (BHB) supplementation in individuals who are undergoing a standard-of-care colonoscopy or flexible sigmoidoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-1,3-Butanediol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BHB supplementation
- description
- Study participants will be taking 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol, for a total of 4 weeks.
- interventionNames
- Dietary Supplement: R-1,3-Butanediol
Primary outcomes (1)
- measure
- Determine whether oral BHB supplementation is safe and tolerable
- timeFrame
- Through study completion, which will be approximately 2 years
- description
- Assessment of patient tolerance of BHB supplements through weekly monitoring of side effects and/or intolerances and patient compliance. We will monitor the percentage of individuals who continue through Visit 2, and the percentage continuing through Visit 3, as well as the compliance with taking the BHB supplement.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age of 18 years or older * Scheduled for a colonoscopy or flexible sigmoidoscopy as part of the patient's standard care * Can provide informed consent Exclusion Criteria: * Subject is pregnant, a prisoner, or is under 18 years of age * Patient is not able to undergo colonoscopy or flexible sigmoidoscopy * Prior total proctocolectomy * History of inflammatory bowel disease * History of diabetes mellitus and are currently on medical diabetes therapy * History of chronic kidney disease with an eGFR \< 60 mL/min/1.73m2 * Cancer diagnosis where the subject is receiving active therapy * Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.