N/A
N=15
Ketone Supplementation in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT04938726 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Pulmonary Function Testing — 1.9; 2.0 L/sec
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketone Monoester (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Function Testing |
1.9; 2.0 | — |
| PRIMARY Inflammatory Markers |
0.3; 0.1 | — |
| SECONDARY Subjective Respiratory Quality of Life |
70.1; 60.3 | — |
Summary
This study will examine the effects of a novel ketone monester supplement on patients with cystic fibrosis experiencing an acute pulmonary exacerbation requiring hospitalization. Patients will undergo standard testing along with blood sampling to examine concentrations of inflammatory markers. Patients will then receive the ketone supplement for 5 days followed by post-testing to examine changes in pulmonary function and inflammatory markers
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CF
- Age >19
- Colonization with P. Aeruginosa
- Acute pulmonary exacerbation requiring inpatient care
Exclusion Criteria
- Concurrent or recent (within 28 d of enrollment) use of corticosteroids
- Inability to produce sputum
- Acute respiratory failure
- Chronic liver or renal disease
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04938726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.