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临床试验/NCT05437640
NCT05437640已完成不适用

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

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in Markers of Skeletal Muscle Metabolism GDF15

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Interpretation of blood biomarkers will be blinded to the intervention assignment.

入排标准

年龄范围
45 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Protein Redistribution Diet

Active Comparator

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

干预措施: Protein Redistribution Diet (Behavioral)

Protein Consistent Diet

Active Comparator

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

干预措施: Protein Consistent Diet (Behavioral)

结局指标

主要结局

Change in Markers of Skeletal Muscle Metabolism GDF15

时间窗: Baseline to 5 weeks

Serum Growth Differentiation Factor 15 (GDF15)

Change in Markers of Skeletal Muscle Metabolism FGF21

时间窗: Baseline to 5 weeks

Serum Fibroblast Growth Factor 21 (FGF21)

Change in Handgrip Strength

时间窗: Baseline to 5 weeks

Handgrip strength assessed via digital dynamometer

Change in Sleep Efficiency

时间窗: Baseline to 5 weeks

Sleep efficiency assessed via actigraphy

Change in Motor Symptoms

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Ferguson, PhD, RD, LD

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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