Clinical trial NCT05437640: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Diet
Protein
Skeletal Muscle
Sleep
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-06-29
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Markers of Skeletal Muscle Metabolism GDF15
timeFrame: Baseline to 5 weeks
measure: Change in Markers of Skeletal Muscle Metabolism FGF21
timeFrame: Baseline to 5 weeks
measure: Change in Handgrip Strength
timeFrame: Baseline to 5 weeks
measure: Change in Sleep Efficiency
timeFrame: Baseline to 5 weeks
measure: Change in Motor Symptoms
timeFrame: Baseline to 5 weeks
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline to 5 weeks
measure: Change in Total Parkinson Symptoms
timeFrame: Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christine C Ferguson, PhD
role: PRINCIPAL_INVESTIGATOR
References: