Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein Redistribution Diet
Protein Consistent Diet
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Diet, Protein, Skeletal Muscle, Sleep
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
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Protein Redistribution Diet
Protein Consistent Diet
Arm Description
PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.
PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.
Outcomes
Primary Outcome Measures
Change in markers of skeletal muscle metabolism GDF15
Serum Growth Differentiation Factor 15 (GDF15)
Change in markers of skeletal muscle metabolism FGF21
Serum Fibroblast Growth Factor 21 (FGF21)
Change in handgrip strength
Handgrip strength assessed via digital dynamometer
Change in sleep efficiency
Sleep efficiency assessed via actigraphy
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.
Secondary Outcome Measures
Change in physical activity
Physical activity assessed via actigraphy
Change in total Parkinson symptoms
Parkinson-related symptoms assessed by total MDS-UPDRS score
Full Information
NCT ID
NCT05437640
First Posted
June 23, 2022
Last Updated
June 22, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05437640
Brief Title
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
Official Title
Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Diet, Protein, Skeletal Muscle, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Interpretation of muscle strength assessment, motor and non-motor symptoms, and blood biomarkers will be blinded to the intervention assignment.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Protein Redistribution Diet
Arm Type
Active Comparator
Arm Description
PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.
Arm Title
Protein Consistent Diet
Arm Type
Active Comparator
Arm Description
PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.
Intervention Type
Behavioral
Intervention Name(s)
Protein Redistribution Diet
Other Intervention Name(s)
PRD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Protein Consistent Diet
Other Intervention Name(s)
PCD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in markers of skeletal muscle metabolism GDF15
Description
Serum Growth Differentiation Factor 15 (GDF15)
Time Frame
Baseline to 5 weeks
Title
Change in markers of skeletal muscle metabolism FGF21
Description
Serum Fibroblast Growth Factor 21 (FGF21)
Time Frame
Baseline to 5 weeks
Title
Change in handgrip strength
Description
Handgrip strength assessed via digital dynamometer
Time Frame
Baseline to 5 weeks
Title
Change in sleep efficiency
Description
Sleep efficiency assessed via actigraphy
Time Frame
Baseline to 5 weeks
Title
Change in motor symptoms
Description
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.
Time Frame
Baseline to 5 weeks
Secondary Outcome Measure Information:
Title
Change in physical activity
Description
Physical activity assessed via actigraphy
Time Frame
Baseline to 5 weeks
Title
Change in total Parkinson symptoms
Description
Parkinson-related symptoms assessed by total MDS-UPDRS score
Time Frame
Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine C Ferguson, PhD
Phone
205-934-1167
Email
cfergus2@uab.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine C Ferguson, PhD
Phone
205-934-1167
Email
cfergus2@uab.edu
First Name & Middle Initial & Last Name & Degree
Christine C Ferguson, PhD
First Name & Middle Initial & Last Name & Degree
Anna Thalacker-Mercer, PhD
First Name & Middle Initial & Last Name & Degree
Amy Amara, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimizing Protein Patterns for Skeletal Muscle Preservation and Sleep in the Medical Management of Parkinson Disease
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