N/A
N=12
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05437640 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Markers of Skeletal Muscle Metabolism GDF15
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Protein Redistribution Diet (Behavioral); Protein Consistent Diet (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Markers of Skeletal Muscle Metabolism GDF15 |
— | — |
| PRIMARY Change in Markers of Skeletal Muscle Metabolism FGF21 |
— | — |
| PRIMARY Change in Handgrip Strength |
— | — |
| PRIMARY Change in Sleep Efficiency |
— | — |
| PRIMARY Change in Motor Symptoms |
11.27; 9.58; 9.45; 9.42 | — |
| SECONDARY Change in Physical Activity |
— | — |
| SECONDARY Change in Total Parkinson Symptoms |
52.09; 51.17; 47.18; 48.75 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05437640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.