Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT05437640
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Protein Redistribution Diet — BEHAVIORALPD participants will be instructed by a Registered Dietitian to consume 10 grams or less of protein until their evening meal. They will then consume a high protein evening meal to meet their protein needs. They will receive one-on-one education and supportive materials to follow diet plan.
- Protein Consistent Diet — BEHAVIORALPD participants will be instructed by a Registered Dietitian to consume 20-30 grams of protein per meal. They will receive one-on-one education and supportive materials to follow diet plan.
Study Details
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.
Key Dates
- Start date
- Oct 1, 2022
- Status verified
- Jun 2025
- Primary completion
- Nov 25, 2024
- Completion
- Nov 25, 2024
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Protein Redistribution DietPD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.
- Active Comparator: Protein Consistent DietPD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.
Primary Outcome Measure
Change in Markers of Skeletal Muscle Metabolism GDF15 [ Time Frame: Baseline to 5 weeks ]
Locations (1)
| Facility | City | State | ZIP |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 |
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