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Behavioural Intervention
Exercise + Ketone Supplement for Parkinson's Disease (CYCLE Trial)
N/A
Recruiting
Led By Chatkaew Pongmala, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after approximately 2-weeks of intervention
Awards & highlights
CYCLE Trial Summary
This trial tests how an exercise program plus a ketone supplement can improve exercise capacity in people with Parkinson's disease.
Who is the study for?
This trial is for individuals with Parkinson's Disease who can safely perform exercises like cycling. It's not suitable for those with recent heart issues, uncontrolled diabetes, pregnancy, severe dementia, or conditions that make exercise unsafe such as significant pain or active rheumatoid arthritis.Check my eligibility
What is being tested?
The study aims to see if a ketone ester beverage improves muscle strength and cardiovascular response when combined with an exercise program (cycling) in people with Parkinson's compared to just exercising while taking an electrolyte beverage.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort from the ketone ester beverage. Exercise might cause fatigue or muscle soreness. Specific side effects will depend on individual health conditions.
CYCLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after approximately 2-weeks of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after approximately 2-weeks of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in duration of 80 rpm endurance test
Change in isometric quadricep muscle strength
Change in oxygen uptake (VO2 max)
CYCLE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketone Ester Beverage & ExerciseExperimental Treatment2 Interventions
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C8-KE) of Juvenescence Cognitive Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Group II: Electrolyte Beverage & ExercisePlacebo Group2 Interventions
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
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,122 Total Patients Enrolled
Chatkaew Pongmala, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart or lung problems that affect my ability to exercise.I experience severe symptoms like dizziness or pain that prevent me from exercising safely.My diabetes is not well-managed.I have had recent heart issues or changes in my heart health.I cannot use steps, stand, walk, or cycle.I have an active case of rheumatoid arthritis.I have a history of chronic pain that is not well-managed.I have been diagnosed with Parkinson's Disease.
Research Study Groups:
This trial has the following groups:- Group 1: Ketone Ester Beverage & Exercise
- Group 2: Electrolyte Beverage & Exercise
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently open to recruitment?
"According to clinicaltrials.gov, this ongoing trial is actively recruiting suitable participants. It was first advertised on July 28th of 2023 and its details were most recently revised the same day."
Answered by AI
How many participants are being accepted into this research endeavor?
"Confirmed. Clinicaltrials.gov verifies that this experiment, first uploaded on July 28th 2023, is actively searching for test subjects. The team seeks 16 participants from a single recruitment site."
Answered by AI
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