Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione)
研究概览
简要总结
The goal of this clinical trial is to learn if a tailored amino acid supplement works to help adults living with Parkinson's disease to improve nutrition, metabolic function, body composition, and physical and mental function. The main questions it aims to answer are:
Does the tailored amino acid supplement increase essential amino acids (nutritional status)?
Does the tailored amino acid supplement increase an antioxidant (complex amino acid) and decrease an amino acid associated with oxidative stress?
Does the tailored amino acid supplement improve physical and mental health compared to a placebo supplement?
Researchers will compare the tailored amino acid supplement to a placebo (a look-alike substance that contains no active ingredients) to see if the tailored amino acid supplements work to support health for people with Parkinson's disease.
Participants will:
Take the tailored amino acid supplement or a placebo every day for 6 months, visit the lab at baseline, after 3 months, and after 6 months for fasting blood draws, body composition assessment, and physical and mental health testing and keep a diary of their food intake and supplement intake.
详细描述
The purpose of this trial is to determine the effects of a targeted amino acid supplement (T-AA) specifically designed to correct characteristic amino acid deficiencies and meet the unique nutritional needs of people with Parkinson's disease (PD) on 1) plasma amino acid (AA) bioavailability, 2) metabolic function, 3) body composition, 4) physical function and 5) self-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusionary Criteria:
- •Male and Females.
- •50-80 Years.
- •Previous diagnosis of idiopathic Parkinson's Disease by patient report.
- •Use of dopamine replacement medication (e.g. levodopa) for at least 2 years.
- •On a stable dose of dopamine replacement medication for at least 3 months with no plans for change in the next two months.
- •Exclusionary criteria
- •Apparent cognitive impairment as determined by phone screening (Telephone Interview for Cognitive Status <29).
- •Diagnosis of Parkinsonism or atypical Parkinson's Disease.
- •Prescription of Dopamine antagonist.
- •Any unstable medical condition.
- •Use of Deep Brain Stimulation.
- •Gastric or Bowel resection surgery.
- •Contraindications to blood draw.
排除标准
- 未提供
研究组 & 干预措施
Control
The inert amino acid (alanine) will serve as an isonitrogenous control.
干预措施: Control (placebo) (Dietary Supplement)
Targeted Amino Acid Supplement
Blend of the essential amino acids (Leucine & Tryptophan), a conditionally essential amino acids (Arginine & Taurine), and non-essential amino acids (Glutamate & Tyrosine) designed to meet the unique nutritional needs of people with Parkinson's disease (PD).
干预措施: Targeted Amino Acid Supplement (Dietary Supplement)
结局指标
主要结局
Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione)
时间窗: Baseline, 3 months, and 6 months
Circulating amino acid concentrations will be measured from blood samples using high performance liquid chromatography using a solid phase column specifically designed to test amino acids (e.g. 00F-4435-E0, Phenomenex, USA) along with appropriate column guards (e.g. AJ0-7597 \& KJ0-4282, Phenomenex, USA) and liquid phases. This analysis will be performed at the Laboratory of Mass Spectroscopy and Omics Analysis.
Oxidative stress
时间窗: Baseline, 3 months, and 6 months
Oxidative stress will be assessed with reduced/oxidized glutathione assays (e.g. ab138881, ABCAM, USA). It is a quantitative bioassay and will be assessed using laboratory facilities.
Oxidative stress
时间窗: Baseline, 3 months, 6 months
Oxidative stress will be measured using a total antioxidant power test (e.g. ab65329, ABCAM, USA). It is a quantitative bioassay and will be performed using the laboratory facilities.
次要结局
- Physical function: Physical activity(7 days prior to baseline visit and 7 days after the 6-month visit)
- Body composition: Bioelectrical impedance(Baseline, 3 months, 6 months)
- Body composition: Ultrasound & Shear Wave Elastography (Tissue Organization & Fibrosis)(Baseline, 3 months, 6 months)
- Physical function: Gait speed (4-meter walking test)(baseline, 3 months, 6 months)
- Physical function: Balance (Mini Balance Evaluation System Test)(baseline, 3 months, 6 months)
- Physical function: Gait speed (10-meter walk test)(baseline, 3 months, 6 months)
- Physical function: Functional lower extremity strength (5 Times Sit to Stand Test)(baseline, 3 months, 6 months)
- Physical function: Grip strength(baseline, 3 months, 6 months)
- Self-reported outcome: Fatigue (Parkinson's Fatigue Scale)(baseline, 3 months, 6 months)
- Self-reported outcome: Sleep (Scales for Outcomes in Parkinson disease- Sleep, nighttime sleep)(baseline, 3 months, 6 months)
- Physical function: Maximal voluntary isometric contraction(baseline, 3 months, 6 months)
- Self-reported outcome: Quality of Life (Parkinson Disease Questionnaire-39)(baseline, 3 months, 6 months)
- Self-reported outcome: Sleep (Scales for Outcomes in Parkinson disease- Sleep, daytime sleepiness)(Baseline, 3 months, 6 months)
- Self-reported outcome: Sleep (Scales for Outcomes in PD-Sleep, Global sleep quality)(Baseline, 3 months, 6 months)
- Self-reported outcome: Mood (Profile of Mood State)(baseline, 3 months, 6 months)
- Self-reported outcome: Anxiety (Beck Anxiety Inventory)(baseline, 3 months, 6 months)
- Self-reported outcome: Motivation (Behavioral Regulation in Exercise Questionnaire-2)(baseline, 3 months, 6 months)
- Self-reported outcome: Depression (Geriatric Depression Scale-short form)(baseline, 3 months, 6 months)
- Insulin sensitivity(baseline, 3 months, 6 months)
研究者
Cristina Colon-Semenza
Assistant Professor
University of Connecticut