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

NCT05437640 | Completed Results

• 2 other identifiers: IRB-300009538P30DK056336
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Diet; Protein; Skeletal Muscle; Sleep

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (2)

• Change in Physical Activity

  Baseline to 5 weeks

• Change in Total Parkinson Symptoms

  Baseline to 5 weeks. Total score ranges from 0-260 with higher scores indicating greater symptom severity.

Study Arms (2)

Protein Redistribution Diet

ACTIVE COMPARATOR

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

Behavioral: Protein Redistribution Diet

Protein Consistent Diet

ACTIVE COMPARATOR

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

Behavioral: Protein Consistent Diet

Interventions

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.

Also known as: PRD

Protein Redistribution Diet

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.

Also known as: PCD

Protein Consistent Diet

Eligibility Criteria

• Age: 45 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of idiopathic PD for 5 or more years
• years or older
• On a stable levodopa regimen for 3 or more months
• Self-reported to experience motor fluctuations

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Christine Ferguson
• Organization: University of Alabama at Birmingham

cfergus2@uab.edu

205-934-7773

Study Officials

• Christine C Ferguson, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interpretation of blood biomarkers will be blinded to the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: October 1, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)