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The main purpose of this study is to assess changes in exercise capacity in people with Parkinson's disease before and after an exercise training program with ketone ester supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-Session Ketone Ester Beverage & Exercise | Experimental | 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. |
|
| 5-Session Electrolyte Beverage & Exercise | Placebo Comparator | 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 |
|
| 12-Session Ketone Ester Beverage & Exercise | Experimental | 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. |
|
| 12-Session Electrolyte Beverage & Exercise | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Ester Beverage | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Duration of 80 Rpm Endurance Test | 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. | After approximately 2 weeks of intervention |
| Change in Oxygen Uptake (VO2 Max) | VO2 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. | After approximately 2 weeks of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chatkaew Pongmala, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Domino's Farms | Ann Arbor | Michigan | 48105 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. |
| 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 | Change in Duration of 80 Rpm Endurance Test | 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. | 1 participant in the 5-session Ketone Ester group completed testing, but outcome measure data was not obtained. | Posted | Mean | Standard Deviation | minutes | After approximately 2 weeks of intervention |
|
From time of enrollment to last study visit (2-6 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 5-Session 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 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chatkaew Pongmala, PhD | University of Michigan | 734-936-1168 | pchatkae@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2024 | Dec 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2024 | Dec 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Electrolyte Beverage | Dietary Supplement | Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise. |
|
| Cycling Intervention | Behavioral | 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. | Count of Participants | Participants |
|
| Region of Enrollment | Of the 19 participants who started the 5-session intervention, 4 of those continued to complete 12-sessions. | Number | participants |
|
| OG001 | 5-Session Electrolyte Beverage & Exercise | 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. |
| OG002 | 12-Session 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 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. |
| OG003 | 12-Session Electrolyte Beverage & Exercise | 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. |
|
|
| Primary | Change in Oxygen Uptake (VO2 Max) | VO2 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. | Posted | Mean | Standard Deviation | mL/kg/min | After approximately 2 weeks of intervention |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | 5-Session Electrolyte Beverage & Exercise | 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. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG002 | 12-Session 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 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | 12-Session Electrolyte Beverage & Exercise | 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. | 0 | 2 | 0 | 2 | 1 | 2 |
| Sleep Changes | General disorders | Systematic Assessment |
|
| GI Upset | Gastrointestinal disorders | Systematic Assessment |
|
| Controlled Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Finger Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Light Headedness | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
|
| Illness | Infections and infestations | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Post-Intervention |
|