CompletedNot Applicable

Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease

United States12 participantsStarted 2022-10-01

Plain-language summary

The purpose of this pilot study is to generate preliminary data on the impact of the dietary protein pattern on markers of skeletal muscle health and drug efficacy in Parkinson disease.

Who can participate

Age range

45 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of idiopathic PD for 5 or more years * 45 years or older * On a stable levodopa regimen for 3 or more months * Self-reported to experience motor fluctuations Exclusion Criteria: * Following a specific diet that would preclude participation * Renal disease * Deep brain stimulation * Known narcolepsy * Untreated sleep apnea * Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Markers of Skeletal Muscle Metabolism GDF15

Timeframe: Baseline to 5 weeks

Change in Markers of Skeletal Muscle Metabolism FGF21

Timeframe: Baseline to 5 weeks

Change in Handgrip Strength

Timeframe: Baseline to 5 weeks

Change in Sleep Efficiency

Timeframe: Baseline to 5 weeks

Change in Motor Symptoms

Timeframe: Baseline to 5 weeks

Trial details

NCT IDNCT05437640

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25

Results submitted2025-03-20

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

45 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Markers of Skeletal Muscle Metabolism GDF15

Timeframe: Baseline to 5 weeks

Change in Markers of Skeletal Muscle Metabolism FGF21

Timeframe: Baseline to 5 weeks

Change in Handgrip Strength

Timeframe: Baseline to 5 weeks

Change in Sleep Efficiency

Timeframe: Baseline to 5 weeks

Change in Motor Symptoms

Timeframe: Baseline to 5 weeks