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

NCT ID: NCT05948956

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-28

Study Completion Date

2025-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5-Session Ketone Ester Beverage & Exercise

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.

Group Type EXPERIMENTAL

Ketone Ester Beverage

Intervention Type 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.

Cycling Intervention

Intervention Type 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.

5-Session 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

Group Type PLACEBO_COMPARATOR

Electrolyte Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.

Cycling Intervention

Intervention Type 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 Ketone Ester Beverage & Exercise

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.

Group Type EXPERIMENTAL

Ketone Ester Beverage

Intervention Type 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.

Cycling Intervention

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Electrolyte Beverage

Intervention Type DIETARY_SUPPLEMENT

Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.

Cycling Intervention

Intervention Type 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.

Interventions

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Ketone Ester Beverage

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.

Intervention Type DIETARY_SUPPLEMENT

Electrolyte Beverage

Participants will consume an electrolyte solution diluted in water, before each of 5 or 12 1-hour sessions of aerobic exercise.

Intervention Type DIETARY_SUPPLEMENT

Cycling Intervention

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Qitone Pro-ketone Powder ™

Eligibility Criteria

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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.)
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Chatkaew Pongmala

Research Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chatkaew Pongmala, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Domino's Farms

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HUM00232413

Identifier Type: -

Identifier Source: org_study_id

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