Trial Outcomes & Findings for Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease (NCT NCT05948956)
NCT ID: NCT05948956
Last Updated: 2026-04-28
Results Overview
Participants will cycle at their personalized fixed wattage at 80 rpm until failure, defined as the point at which the participant could not sustain a cadence of \>70 rpm for a cumulative total of 20 s, or until voluntarily choosing to end the test. Change in duration will be calculated by subtracting the baseline duration from duration at follow-up. Greater duration indicates better endurance. Measured in minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
After approximately 2 weeks of intervention
Results posted on
2026-04-28
Participant Flow
21 people were recruited for the study. Of those 21, 2 withdrew prior to completing the baseline. The study initially involved a 5-session intervention, which was later extended to a 12-session intervention. All 19 completed the 5-session intervention, while 4 of those 18 completed the 12-session intervention.
Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. The total number of participants that were automatically calculated is inflated due to the 4 participants who participated in both interventions.
Participant milestones
| Measure |
Ketone Ester Beverage & Exercise
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
Electrolyte Beverage & Exercise
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
5 Sessions Completed
|
9
|
10
|
|
Overall Study
12 Sessions Completed
|
2
|
2
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
Baseline characteristics by cohort
| Measure |
Ketone Ester Beverage & Exercise
n=9 Participants
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
Electrolyte Beverage & Exercise
n=10 Participants
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
5 Sessions
|
69.22 years
STANDARD_DEVIATION 4.55 • n=9 Participants • Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
|
66.8 years
STANDARD_DEVIATION 8.39 • n=10 Participants • Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
|
67.95 years
STANDARD_DEVIATION 6.78 • n=19 Participants • Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
|
|
Age, Continuous
12 Sessions
|
72 years
STANDARD_DEVIATION 1.41 • n=2 Participants • Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
|
74.5 years
STANDARD_DEVIATION 3.54 • n=2 Participants • Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
|
73.25 years
STANDARD_DEVIATION 2.63 • n=4 Participants • Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions.
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
18 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
10 participants
n=10 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: After approximately 2 weeks of interventionPopulation: 1 participant in the 5-session Ketone Ester group completed testing, but outcome measure data was not obtained.
Participants will cycle at their personalized fixed wattage at 80 rpm until failure, defined as the point at which the participant could not sustain a cadence of \>70 rpm for a cumulative total of 20 s, or until voluntarily choosing to end the test. Change in duration will be calculated by subtracting the baseline duration from duration at follow-up. Greater duration indicates better endurance. Measured in minutes.
Outcome measures
| Measure |
5-Session Ketone Ester Beverage & Exercise
n=8 Participants
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
5-Session Electrolyte Beverage & Exercise
n=10 Participants
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
12-Session Ketone Ester Beverage & Exercise
n=2 Participants
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
12-Session Electrolyte Beverage & Exercise
n=2 Participants
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
|---|---|---|---|---|
|
Change in Duration of 80 Rpm Endurance Test
Baseline
|
26.31 minutes
Standard Deviation 19.10
|
25.84 minutes
Standard Deviation 15.76
|
15.62 minutes
Standard Deviation 0.72
|
12.12 minutes
Standard Deviation 4.07
|
|
Change in Duration of 80 Rpm Endurance Test
Post-Intervention
|
31.89 minutes
Standard Deviation 19.57
|
33.21 minutes
Standard Deviation 20.74
|
20.16 minutes
Standard Deviation 6.84
|
15.52 minutes
Standard Deviation 4.97
|
PRIMARY outcome
Timeframe: After approximately 2 weeks of interventionVO2 max (defined as volume of oxygen consumed in mL divided by body weight in kg per minute) will be measured during a controlled cycling session on a stationary bike. Participants will begin at a cadence of 80 rpm at 50 watts for 4 minutes. Thereafter, wattage will increase by 10 watts every 2 minutes until the participant voluntarily ends the session or is no longer able to sustain a cadence of \>70 rpm. Participants will wear a face mask that measures their oxygen intake during the session. Change in VO2 max will be calculated by subtracting the baseline VO2 max from VO2 max at follow-up. Greater VO2 max indicates better cardiorespiratory fitness. VO2 max will be measured after 4 minute period.
Outcome measures
| Measure |
5-Session Ketone Ester Beverage & Exercise
n=8 Participants
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
5-Session Electrolyte Beverage & Exercise
n=10 Participants
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
12-Session Ketone Ester Beverage & Exercise
n=2 Participants
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
12-Session Electrolyte Beverage & Exercise
n=2 Participants
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
|---|---|---|---|---|
|
Change in Oxygen Uptake (VO2 Max)
Baseline
|
19.44 mL/kg/min
Standard Deviation 2.79
|
19.87 mL/kg/min
Standard Deviation 2.27
|
19.30 mL/kg/min
Standard Deviation 0.71
|
18.75 mL/kg/min
Standard Deviation 0.07
|
|
Change in Oxygen Uptake (VO2 Max)
Post-Intervention
|
18.80 mL/kg/min
Standard Deviation 2.80
|
19.15 mL/kg/min
Standard Deviation 3.35
|
16.95 mL/kg/min
Standard Deviation 3.18
|
19.15 mL/kg/min
Standard Deviation 2.90
|
Adverse Events
5-Session Ketone Ester Beverage & Exercise
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
5-Session Electrolyte Beverage & Exercise
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
12-Session Ketone Ester Beverage & Exercise
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
12-Session Electrolyte Beverage & Exercise
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5-Session Ketone Ester Beverage & Exercise
n=9 participants at risk
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
5-Session Electrolyte Beverage & Exercise
n=10 participants at risk
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
12-Session Ketone Ester Beverage & Exercise
n=2 participants at risk
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-Ketone Powder™ and electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise.
Ketone Ester Beverage: Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Qitone Pro-ketone Powder ™ and electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
|
12-Session Electrolyte Beverage & Exercise
n=2 participants at risk
Participants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise
Electrolyte Beverage: Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling Intervention: Five or twelve 1-hour sessions of cycling on the ergometer over a 2-6 week period. Sessions will consist of a 10 min warm up followed by 8 intervals consisting of 3 min "fast" cycling at 80-90 rpm followed by 2 min of "slow" cycling at ≤60rpm, followed by a 10-minute cool-down.
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|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
11.1%
1/9 • From time of enrollment to last study visit (2-6 weeks).
|
20.0%
2/10 • From time of enrollment to last study visit (2-6 weeks).
|
50.0%
1/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
General disorders
Sleep Changes
|
11.1%
1/9 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/10 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
50.0%
1/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
Gastrointestinal disorders
GI Upset
|
33.3%
3/9 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/10 • From time of enrollment to last study visit (2-6 weeks).
|
50.0%
1/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
Injury, poisoning and procedural complications
Controlled Fall
|
0.00%
0/9 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/10 • From time of enrollment to last study visit (2-6 weeks).
|
50.0%
1/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
Injury, poisoning and procedural complications
Finger Pain
|
11.1%
1/9 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/10 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
General disorders
Light Headedness
|
11.1%
1/9 • From time of enrollment to last study visit (2-6 weeks).
|
10.0%
1/10 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
General disorders
Headache
|
0.00%
0/9 • From time of enrollment to last study visit (2-6 weeks).
|
10.0%
1/10 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
Infections and infestations
Illness
|
11.1%
1/9 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/10 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9 • From time of enrollment to last study visit (2-6 weeks).
|
10.0%
1/10 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
0.00%
0/2 • From time of enrollment to last study visit (2-6 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place