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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK056336 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
Parkinson's disease (PD) is a complex neurological disease that affects ~6.1 million people worldwide - mostly older adults >60 years. The most effective treatment for PD is dopaminergic therapy, particularly levodopa (Ldopa). People with PD have variable responses to Ldopa, including degrees of motor fluctuations (MF) throughout the day. The half-life of Ldopa is ~1.5 h and therefore, dosage and timing are essential to mitigate MF. Ldopa is a large neutral amino acid (LNAA), and the bioavailability of Ldopa is compromised when simultaneously ingested with LNAA (e.g., leucine). Both Ldopa and LNAAs from food are absorbed through the same intestinal transporter, but LNAAs from food are preferentially absorbed by the enterocyte, limiting the bioavailability of Ldopa. Thus, the scientific community often recommends the protein-redistribution diet (PRD). With PRD, patients limit protein (<10 g) at the desired time of medication efficacy (daytime) and meet their protein needs during the evening meal (~70+g). There are deleterious implications of the PRD for older adults with PD; consumption of >30 g of protein, in a single meal, will not sufficiently increase muscle protein synthesis. Additionally, the impact of the PRD on skeletal muscle quality and function has not been determined, and it is unclear, based on prior studies, whether the PRD enhanced drug absorption. Therefore, the objective of this study is to address these gaps in knowledge. This study will quantify the effects of dietary protein pattern on skeletal muscle in PD; determine the effects of dietary protein pattern on sleep quality in PD. This study is an acute, 5-week, crossover intervention with PD participants randomly assigned to first adhere to either the PCD or PRD. Participants will receive diet prescriptions and meal plans for their respective diet, and outcome measures will be assessed at days 0, 14, 21, and 35.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Redistribution Diet | Active Comparator | PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet. |
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| Protein Consistent Diet | Active Comparator | PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein Redistribution Diet | Behavioral | PD 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Markers of Skeletal Muscle Metabolism GDF15 | Serum Growth Differentiation Factor 15 (GDF15) | Baseline to 5 weeks |
| Change in Markers of Skeletal Muscle Metabolism FGF21 | Serum Fibroblast Growth Factor 21 (FGF21) | Baseline to 5 weeks |
| Change in Handgrip Strength | Handgrip strength assessed via digital dynamometer | Baseline to 5 weeks |
| Change in Sleep Efficiency | Sleep efficiency assessed via actigraphy | Baseline to 5 weeks |
| Change in Motor Symptoms | Motor symptoms assessed via the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. Part II ranges from 0-52 with higher scores indicating greater symptom severity. | Baseline to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity | Physical activity assessed via actigraphy | Baseline to 5 weeks |
| Change in Total Parkinson Symptoms | Parkinson-related symptoms assessed by total MDS-UPDRS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine C Ferguson, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Protein Consistent Diet, Then Protein Redistribution Diet | PD participants first were randomized to follow the Protein Consistent Diet for 2 weeks. After a washout period of 2 weeks, they then followed by a Protein Redistribution Diet. |
| FG001 | Protein Redistribution Diet, Then Protein Consistent Diet | PD participants first were randomized to follow a Protein Redistribution diet. After a washout period of 2 weeks, they then followed a Protein Consistent Diet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 weeks) |
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| Washout (1 week) |
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| Second Intervention (2 weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | All participants were scheduled to follow both dietary interventions. One participant withdrew during the washout phase. Enrolled n=12, final n=11 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Markers of Skeletal Muscle Metabolism GDF15 | Serum Growth Differentiation Factor 15 (GDF15) | Posted | Jun 2026 | Mean | Standard Deviation | pg/mL | Baseline to 5 weeks |
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Adverse event information was assessed during the study period (5 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Protein Consistent Diet | PD 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. One participant withdrew during the washout phase after completing the Protein Consistent Diet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Ferguson | University of Alabama at Birmingham | 205-934-7773 | cfergus2@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2025 | May 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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PD participants randomly assigned to first adhere to either the Protein Consistent Diet or Protein Redistribution Diet for 2 weeks. Participants will enter a 1-week washout period between the diets where they follow their typical diet and then follow the other diet prescription for 2 weeks.
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Interpretation of blood biomarkers will be blinded to the intervention assignment.
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| Protein Consistent Diet | Behavioral | PD 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. |
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| Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity. |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
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| Primary | Change in Markers of Skeletal Muscle Metabolism FGF21 | Serum Fibroblast Growth Factor 21 (FGF21) | Posted | Jun 2026 | Mean | Standard Deviation | pg/mL | Baseline to 5 weeks |
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| Primary | Change in Handgrip Strength | Handgrip strength assessed via digital dynamometer | Posted | Jun 2025 | Mean | Standard Deviation | lbs | Baseline to 5 weeks |
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| Primary | Change in Sleep Efficiency | Sleep efficiency assessed via actigraphy | Posted | Jun 2025 | Mean | Standard Deviation | % of time in bed spent asleep | Baseline to 5 weeks |
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| Primary | Change in Motor Symptoms | Motor symptoms assessed via the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. Part II ranges from 0-52 with higher scores indicating greater symptom severity. | Posted | Mean | Standard Deviation | Score | Baseline to 5 weeks |
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| Secondary | Change in Physical Activity | Physical activity assessed via actigraphy | Not Posted | Jun 2026 | Baseline to 5 weeks | Participants |
| Secondary | Change in Total Parkinson Symptoms | Parkinson-related symptoms assessed by total MDS-UPDRS score | Posted | Mean | Standard Deviation | score on a scale | Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity. |
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| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Protein Redistribution Diet | PD 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. No participants experienced adverse events in PRD phase. | 0 | 12 | 0 | 12 | 0 | 12 |
| Migraines | General disorders | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |