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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketone Ester Beverage
Electrolyte Beverage
Cycling Intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Exercise, Ketone Ester, Keto

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Domino's FarmsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketone Ester Beverage & Exercise

Electrolyte Beverage & Exercise

Arm Description

Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C6-KE) of Juvenescence Metabolic Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic 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

Outcomes

Primary Outcome Measures

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.
Change in One-minute Anaerobic Threshold Test Cadence
Participants will then engage in a 1-min anaerobic threshold test. Participants will be instructed to cycle at as high a cadence as possible at the ergometer resistance that achieves their personalized target wattage (calculated from baseline test) when cycling at 80 rpm. Change in cadence will be calculated by subtracting cadence at baseline from cadence at follow-up.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2023
Last Updated
July 28, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05948956
Brief Title
Effects of Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
Acronym
CYCLE
Official Title
Effects of Combined Exercise Training and Ketone Ester on Muscle Strength and Cardiovascular Response in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Exercise, Ketone Ester, Keto

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketone Ester Beverage & Exercise
Arm Type
Experimental
Arm Description
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C6-KE) of Juvenescence Metabolic Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Arm Title
Electrolyte Beverage & Exercise
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone Ester Beverage
Other Intervention Name(s)
Juvenescence Metabolic Switch™
Intervention Description
Participants will consume ketone ester (KE) beverage, consisting of 2 scoops (=25 g C6-KE) of Juvenescence Metabolic Switch ™ and electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Intervention Type
Dietary Supplement
Intervention Name(s)
Electrolyte Beverage
Intervention Description
Participants will consume an electrolyte solution diluted in water, before each of 5 1-hour sessions of aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Cycling Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in duration of 80 rpm endurance test
Description
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.
Time Frame
After approximately 2-weeks of intervention
Title
Change in One-minute Anaerobic Threshold Test Cadence
Description
Participants will then engage in a 1-min anaerobic threshold test. Participants will be instructed to cycle at as high a cadence as possible at the ergometer resistance that achieves their personalized target wattage (calculated from baseline test) when cycling at 80 rpm. Change in cadence will be calculated by subtracting cadence at baseline from cadence at follow-up.
Time Frame
After approximately 2-weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Austin Luker, BS
Phone
734-936-0111
Email
aluker@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chatkaew Pongmala, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Domino's Farms
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Griggs, BA
Phone
734-998-8400
Email
gralexis@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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