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

University of Michigan

Status: Completed

Conditions: Parkinson Disease

Treatments: Dietary Supplement: Electrolyte Beverage; Dietary Supplement: Ketone Ester Beverage; Behavioral: Cycling Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05948956

HUM00232413

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 45+ years old

Volunteers: No 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
• Any contraindications to MRI (metal implants, severe claustrophobia, inability to lie still for 1 hour, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups, including a placebo group

5-Session Ketone Ester Beverage & Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Cycling Intervention

Dietary Supplement: Ketone Ester Beverage

5-Session Electrolyte Beverage & Exercise

Placebo Comparator group

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

Treatment:

Behavioral: Cycling Intervention

Dietary Supplement: Electrolyte Beverage

12-Session Ketone Ester Beverage & Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Cycling Intervention

Dietary Supplement: Ketone Ester Beverage

12-Session Electrolyte Beverage & Exercise

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Cycling Intervention

Dietary Supplement: Electrolyte Beverage