Ketone Supplementation in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Ketone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938726
• Other study ID #: IRB-300007323
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Dietary Supplement:
• Ketone Monoester
Ketone supplement will be taken by mouth at a dose of 15 mL twice per day

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Testing	FEV1.0 (L/sec)	5 days
Primary	Inflammatory markers	Interleukin 1Beta (ug/mL)	5 days
Secondary	Assessment of quality of life, respiratory symptoms, and patient outlook	A questionnaire will be used to assess quality of life and patient outlook 30 days following the intervention	5 days