Trial Outcomes & Findings for Ketone Supplementation in Cystic Fibrosis (NCT NCT04938726)
NCT ID: NCT04938726
Last Updated: 2025-02-13
Results Overview
FEV1.0 (L/sec)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
5 days
Results posted on
2025-02-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketone Supplementation in Cystic Fibrosis
Baseline characteristics by cohort
| Measure |
Ketone Monoester
n=10 Participants
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
|
Placebo
n=5 Participants
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
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysFEV1.0 (L/sec)
Outcome measures
| Measure |
Ketone Monoester
n=9 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Pulmonary Function Testing
|
1.9 L/sec
Standard Deviation 0.9
|
2.0 L/sec
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 5 daysInterleukin 1Beta (pg/mL)
Outcome measures
| Measure |
Ketone Monoester
n=9 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Inflammatory Markers
|
0.3 pg/mL
Standard Deviation 0.1
|
0.1 pg/mL
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 5-7 daysThe 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.
Outcome measures
| Measure |
Ketone Monoester
n=9 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Subjective Respiratory Quality of Life
|
70.1 units on a scale
Standard Deviation 28.5
|
60.3 units on a scale
Standard Deviation 26
|
Adverse Events
Ketone Monoester
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eric P. Plaisance
University of Alabama at Birmingham
Phone: 2057090980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place