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

NCT05948956 | Completed Results

• 1 other identifier: HUM00232413
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Exercise; Ketone Ester; Keto

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

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

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.

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

Dietary Supplement: Electrolyte Beverage; Behavioral: Cycling Intervention

Interventions

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.

Also known as: Qitone Pro-ketone Powder ™

12-Session Ketone Ester Beverage & Exercise; 5-Session Ketone Ester Beverage & Exercise

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.

12-Session Electrolyte Beverage & Exercise; 5-Session Electrolyte Beverage & 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.

12-Session Electrolyte Beverage & Exercise; 12-Session Ketone Ester Beverage & Exercise; 5-Session Electrolyte Beverage & Exercise; 5-Session Ketone Ester Beverage & Exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's Disease

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Domino's Farms

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Results Point of Contact

• Title: Chatkaew Pongmala, PhD
• Organization: University of Michigan

pchatkae@umich.edu

734-936-1168

Study Officials

• Chatkaew Pongmala, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 17, 2023
• Study Start: July 28, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)