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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05437640

Collaborator

(none)

Enrollment

Location

Arms

9.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Protein Redistribution Diet Behavioral: Protein Consistent Diet	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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:

Single (Outcomes Assessor)

Masking Description:

Interpretation of muscle strength assessment, motor and non-motor symptoms, and blood biomarkers will be blinded to the intervention assignment.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Protein Redistribution Diet PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.	Behavioral: 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. Other Names: PRD
Active Comparator: Protein Consistent Diet PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.	Behavioral: 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. Other Names: PCD

Arm

Intervention/Treatment

Active Comparator: Protein Redistribution Diet

PD participants may first be randomized to follow the Protein Redistribution Diet followed by the Protein Consistent Diet.

Behavioral: 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.

Other Names:

PRD

Active Comparator: Protein Consistent Diet

PD participants may first be randomized to follow the Protein Consistent Diet followed by the Protein Redistribution Diet.

Behavioral: 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.

Other Names:

PCD

Outcome Measures

Primary Outcome Measures

Change in markers of skeletal muscle metabolism GDF15 and FGF21 [Baseline to 5 weeks]
Serum Growth Differentiation Factor 15 (GDF15) and Fibroblast Growth Factor 21 (FGF21)
Change in muscle strength [Baseline to 5 weeks]
Muscle strength assessed via Biodex
Change in sleep efficiency [Baseline to 5 weeks]
Sleep efficiency assessed via actigraphy
Change in motor symptoms [Baseline to 5 weeks]
Motor symptoms assessed via the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

Secondary Outcome Measures

Change in physical activity [Baseline to 5 weeks]
Physical activity assessed via actigraphy
Change in total Parkinson symptoms [Baseline to 5 weeks]
Parkinson-related symptoms assessed by total MDS-UPDRS score

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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