Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30DK079626 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Placebo | Placebo Comparator | A placebo is being manufactured by KetoneAid to match the taste and other characteristics of the ketone supplement for blinding purposes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Monoester | Dietary Supplement | Ketone supplement will be taken by mouth at a dose of 15 mL twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function Testing | FEV1.0 (L/sec) | 5 days |
| Inflammatory Markers | Interleukin 1Beta (pg/mL) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric P Plaisance, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) Ketone Monoester: Ketone supplement will be taken by mouth at a dose of 15 mL twice per day |
| FG001 | Placebo | A placebo is being manufactured by KetoneAid to match the taste and other characteristics of the ketone supplement for blinding purposes Ketone Monoester: Ketone supplement will be taken by mouth at a dose of 15 mL twice per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) Ketone Monoester: Ketone supplement will be taken by mouth at a dose of 15 mL twice per day |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pulmonary Function Testing | FEV1.0 (L/sec) | Posted | Mean | Standard Deviation | L/sec | 5 days |
|
7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) Ketone Monoester: Ketone supplement will be taken by mouth at a dose of 15 mL twice per day |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric P. Plaisance | University of Alabama at Birmingham | 2057090980 | plaisep@uab.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2024 | Feb 12, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Two-way ANOVA with repeated measures on time
Not provided
Not provided
All involved with blinded, except for the study pharmacist
| 5-7 days |
A placebo is being manufactured by KetoneAid to match the taste and other characteristics of the ketone supplement for blinding purposes Ketone Monoester: Ketone supplement will be taken by mouth at a dose of 15 mL twice per day |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Inflammatory Markers | Interleukin 1Beta (pg/mL) | Posted | Mean | Standard Deviation | pg/mL | 5 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 5-7 days |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | A placebo is being manufactured by KetoneAid to match the taste and other characteristics of the ketone supplement for blinding purposes Ketone Monoester: Ketone supplement will be taken by mouth at a dose of 15 mL twice per day | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |