Ketone Supplementation in Cystic Fibrosis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Breath Condensate Study in Patients With Cystic Fibrosis.

NCT02056132

Cystic Fibrosis

COMPLETED

Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis

NCT00970346

Cystic Fibrosis

COMPLETED PHASE1

Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis

NCT04496921

Cystic Fibrosis

WITHDRAWN NA

Nutrition Supplement for Cystic Fibrosis

NCT07163078

Cystic Fibrosis (CF)

NOT_YET_RECRUITING NA

Phase I Study of Liposome-Mediated Gene Transfer in Patients With Cystic Fibrosis

NCT00004806

Cystic Fibrosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-way ANOVA with repeated measures on time

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All involved with blinded, except for the study pharmacist

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketone Monoester

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

Group Type EXPERIMENTAL

Ketone Monoester

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Ketone Monoester

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketone Monoester

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No