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OpenTrials
Completed

NCT Number: NCT05437640

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

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.

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Key information

Age range

45 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PRD

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.

Other names: PCD

Primary outcomes

  1. Change in Markers of Skeletal Muscle Metabolism GDF15

    Time frame: Baseline to 5 weeks

    Serum Growth Differentiation Factor 15 (GDF15)

  2. Change in Markers of Skeletal Muscle Metabolism FGF21

    Time frame: Baseline to 5 weeks

    Serum Fibroblast Growth Factor 21 (FGF21)

  3. Change in Handgrip Strength

    Time frame: Baseline to 5 weeks

    Handgrip strength assessed via digital dynamometer

  4. Change in Sleep Efficiency

    Time frame: Baseline to 5 weeks

    Sleep efficiency assessed via actigraphy

  5. Change in Motor Symptoms

    Time frame: Baseline to 5 weeks

    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 outcomes

  1. Change in Physical Activity

    Time frame: Baseline to 5 weeks

    Physical activity assessed via actigraphy

  2. Change in Total Parkinson Symptoms

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

    Parkinson-related symptoms assessed by total MDS-UPDRS score

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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