Parkinson DiseaseCYCLENCT05948956
Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
A study testing Ketone Ester Beverage, Electrolyte Beverage and Cycling Intervention in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ketone Ester Beverage, Electrolyte Beverage and Cycling Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2023to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's Disease
Who cannot join
- Any recent changes in EKG, history of myocardial infarction or other cardiac event or other cardiac contraindications to exercise
- Inability to use a step, stand, walk, or use a stationary cycle ergometer
- History of symptoms in exercise that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema or medication side effects
- History of symptomatic cardiovascular or pulmonary disease interfering with exercise
- History of active rheumatoid arthritis
- History of uncontrolled chronic pain syndrome
Show all 11Show fewer
- Any other history of medical or psychiatric comorbidity precluding safe participation in the project
- Poorly controlled diabetes
- Pregnancy or breastfeeding
- Clinically significant dementia
- Any contraindications to MRI (metal implants, severe claustrophobia, inability to lie still for 1 hour, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- Ketone Ester Beverage, Electrolyte Beverage, Cycling Intervention
- Keywords
- Exercise, Ketone Ester, Keto
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Ester BeverageDietary supplement
Also called Qitone Pro-ketone Powder ™
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.
Electrolyte BeverageDietary supplement
Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.
Cycling InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ketone Ester Beverage; Behavioral: Cycling Intervention |
| 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 Receives: Dietary Supplement: Electrolyte Beverage; Behavioral: Cycling Intervention |
| 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. Receives: Dietary Supplement: Ketone Ester Beverage; Behavioral: Cycling Intervention |
| 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 Receives: Dietary Supplement: Electrolyte Beverage; Behavioral: Cycling Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After approximately 2 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start28 Jul 2023
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chatkaew Pongmala, University of Michigan
- Investigators
- Chatkaew Pongmala, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948956
- Sponsor's protocol ID
- HUM00232413
- Acronym
- CYCLE
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2023
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05948956
- Acronym / sponsor ID
- CYCLE / HUM00232413
- Conditions
- Parkinson Disease
- Keywords
- Exercise, Ketone Ester, Keto
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5-Session Ketone Ester Beverage & Exercise | Experimental | Dietary Supplement: Ketone Ester Beverage, Behavioral: Cycling InterventionParticipants 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 | Dietary Supplement: Electrolyte Beverage, Behavioral: Cycling InterventionParticipants 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 | Dietary Supplement: Ketone Ester Beverage, Behavioral: Cycling InterventionParticipants 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 | Dietary Supplement: Electrolyte Beverage, Behavioral: Cycling InterventionParticipants will consume placebo electrolyte (EL) beverage, consisting of an electrolyte solution diluted in water, before each of 12 1-hour sessions of aerobic exercise |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Parkinson's Disease
Key exclusion criteria (11 listed)
- Any recent changes in EKG, history of myocardial infarction or other cardiac event or other cardiac contraindications to exercise
- Inability to use a step, stand, walk, or use a stationary cycle ergometer
- History of symptoms in exercise that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema or medication side effects
- History of symptomatic cardiovascular or pulmonary disease interfering with exercise
- History of active rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Ester BeverageAlso: Qitone Pro-ketone Powder ™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. | Dietary supplement | 12-Session Ketone Ester Beverage & Exercise, 5-Session Ketone Ester Beverage & Exercise |
| Electrolyte BeverageParticipants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise. | Dietary supplement | 12-Session Electrolyte Beverage & Exercise, 5-Session Electrolyte Beverage & Exercise |
| Cycling InterventionFive 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. | Behavioural | 12-Session Electrolyte Beverage & Exercise, 12-Session Ketone Ester Beverage & Exercise, 5-Session Electrolyte Beverage & Exercise, 5-Session Ketone Ester Beverage & Exercise |
Primary outcome
Change in Duration of 80 Rpm Endurance Test
Time frame: After approximately 2 weeks of intervention
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.
Change in Oxygen Uptake (VO2 Max)
Time frame: After approximately 2 weeks of intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chatkaew Pongmala, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Ester Beverage, Electrolyte Beverage and Cycling Intervention in people with Parkinson Disease, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Duration of 80 Rpm Endurance Test (time frame: After approximately 2 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.