Ketone Supplementation in Cystic Fibrosis

NCT04938726 | Completed Results

• 2 other identifiers: IRB-300007323P30DK079626
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• Pulmonary Function Testing

  FEV1.0 (L/sec)

  5 days

• Inflammatory Markers

  Interleukin 1Beta (pg/mL)

  5 days

Secondary Outcomes (1)

• Subjective Respiratory Quality of Life

  5-7 days

Study Arms (2)

Ketone Monoester

EXPERIMENTAL

The ketone used is from KetoneAid and is commercially available as KE4 and will be consumed at 30 mL twice daily (15 g / dose)

Dietary Supplement: Ketone Monoester

Placebo

PLACEBO COMPARATOR

A placebo is being manufactured by KetoneAid to match the taste and other characteristics of the ketone supplement for blinding purposes

Dietary Supplement: Ketone Monoester

Interventions

Ketone Monoester DIETARY_SUPPLEMENT

Ketone supplement will be taken by mouth at a dose of 15 mL twice per day

Ketone Monoester; Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF
• Age \>19
• Colonization with P. Aeruginosa
• Acute pulmonary exacerbation requiring inpatient care

You may not qualify if:

• Concurrent or recent (within 28 d of enrollment) use of corticosteroids
• Inability to produce sputum
• Acute respiratory failure
• Chronic liver or renal disease
• Pregnancy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Limitations and Caveats

Recruitment was difficult in this population because with the advent of CFTR modulators, patients are remarkably improved in health and have less incentive to participate in clinical studies outside of this domain.

Results Point of Contact

• Title: Dr. Eric P. Plaisance
• Organization: University of Alabama at Birmingham

plaisep@uab.edu

2057090980

Study Officials

• Eric P Plaisance, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All involved with blinded, except for the study pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair

Model Details: Two-way ANOVA with repeated measures on time

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 24, 2021
• Study Start: November 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)