Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease (CYCLE)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Cycling Intervention; Dietary supplement: Electrolyte Beverage; Dietary supplement: Ketone Ester Beverage

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Austin Luker, BS; Phone Number: 734-936-0111; Email: aluker@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • Domino's Farms
      • Contact: Robert Vangel, BSc; Phone Number: 734-936-1168; Email: rvangel@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Parkinson's Disease

Exclusion Criteria:

• 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
• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Behavioral: Cycling Intervention; Five 1-hour sessions of cycling on the ergometer over a 2-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.; Dietary supplement: Electrolyte Beverage; Participants will consume an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Experimental: Ketone Ester Beverage & Exercise; 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.	Behavioral: Cycling Intervention; Five 1-hour sessions of cycling on the ergometer over a 2-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.; Dietary supplement: Ketone Ester Beverage; 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.; Other Names: Juvenescence Cognitive Switch™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	After approximately 2-weeks of intervention
Change in isometric quadricep muscle strength	Participants will sit on an ergometer with their knee secured at a 90-degree angle. Participants will be instructed to perform a maximal effort static knee extension against the resistance of the ergometer for up to 5 trials. Isometric quadricep muscle strength will be measured as the mean torque in Newtons exerted on the ergometer by the participant across all trials. Change in strength will be calculated by subtracting the mean torque at baseline from the mean torque at follow up. Greater torque indicates greater isometric quadricep strength.	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.	After approximately 2-weeks of intervention

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Chatkaew Pongmala, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Ketone Ester; Keto
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HUM00232413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No