Clinical trial NCT04938726: Ketone Supplementation in Cystic Fibrosis
Official title: Ketone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-06-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-way ANOVA with repeated measures on time
Primary purpose: TREATMENT

Brief 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

Detailed description: 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

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

Primary outcomes:
measure: Pulmonary Function Testing
timeFrame: 5 days
measure: Inflammatory Markers
timeFrame: 5 days
Secondary outcomes:
measure: Subjective Respiratory Quality of Life
timeFrame: 5-7 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Eric P Plaisance, PhD
role: PRINCIPAL_INVESTIGATOR
References: