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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437640
• Other study ID #: IRB-300009538
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Christine C Ferguson, PhD
• Phone: 205-934-7773
• Email: cfergus2[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in markers of skeletal muscle metabolism GDF15	Serum Growth Differentiation Factor 15 (GDF15)	Baseline to 5 weeks
Primary	Change in markers of skeletal muscle metabolism FGF21	Serum Fibroblast Growth Factor 21 (FGF21)	Baseline to 5 weeks
Primary	Change in handgrip strength	Handgrip strength assessed via digital dynamometer	Baseline to 5 weeks
Primary	Change in sleep efficiency	Sleep efficiency assessed via actigraphy	Baseline to 5 weeks
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.	Baseline to 5 weeks
Secondary	Change in physical activity	Physical activity assessed via actigraphy	Baseline to 5 weeks
Secondary	Change in total Parkinson symptoms	Parkinson-related symptoms assessed by total MDS-UPDRS score	Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity.