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
Up to 25 hospitalized patients with cystic fibrosis will take part in this study at UAB. Patients will be randomly assigned to receive either an exogenous ketone or placebo supplement. Participants will take the ketone or placebo for 5 days during hospitalization. Participants will drink one 60 mL bottle twice daily of either the ketone or placebo. On day 1 and day 5, before the patient drinks the ketone (or placebo) the patient will be asked to fast overnight for 8 hours. Following administration of the first morning dose of ketones (or placebo) blood samples will be obtained from a finger stick before (time 0 min) and following (15, 30, 60, 90, and 120 min) after they drink the supplement. A commercially available ketone meter (Keto-Mojo, Napa, CA) that provides instant assessment of circulating ketone concentrations will be used to measure ketone concentrations in the blood. Medical history history will be obtained at hospitalization. The study team will also examine the body for any abnormal signs and symptoms. Sputum and blood will be collected prior to and following the ketone supplement or placebo. The hypothesis is that ketone supplementation will reduce inflammation via a well known inflammatory pathway to improve outcomes in patients with cystic fibrosis experiencing an acute pulmonary exacerbation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Ketone supplement will be taken by mouth at a dose of 15 mL twice per day
University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Function Testing
FEV1.0 (L/sec)
Time frame: 5 days
Inflammatory Markers
Interleukin 1Beta (pg/mL)
Time frame: 5 days
Subjective Respiratory Quality of Life
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) was used to examine multiple domains related to quality of life. An outcome of the study was to examine subjective ratings of respiratory function using the CFQ-R comparing the ketone treated (KME) vs. control (placebo-control) groups. The measurement range for the score is from 0 - 100 with higher values representing a better outcome.
Time frame: 5-7 days
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