Purpose

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

Eligibility

Eligible Ages
Between 45 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Treatment
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.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Christine C Ferguson, PhD
205-934-1167
cfergus2@uab.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Christine C Ferguson, PhD
205-934-1167
cfergus2@uab.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.