Daily Amino Acid Supplementation for People With Parkinson's Disease

Официальное название

Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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).
• Пищевая добавка Control (placebo)
  The inert amino acid (alanine) will serve as an isonitrogenous control.

Первичные конечные точки

• Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione) [Срок оценки: Baseline, 3 months, and 6 months]
• Oxidative stress [Срок оценки: Baseline, 3 months, 6 months]
• Oxidative stress [Срок оценки: Baseline, 3 months, and 6 months]

Вторичные конечные точки (12)

• Body composition: Bioelectrical impedance [Срок оценки: Baseline, 3 months, 6 months]
• Body composition: Ultrasound & Shear Wave Elastography (Tissue Organization & Fibrosis) [Срок оценки: Baseline, 3 months, 6 months]
• Physical function: Physical activity [Срок оценки: 7 days prior to baseline visit and 7 days after the 6-month visit]
• Physical function: Balance (Mini Balance Evaluation System Test) [Срок оценки: baseline, 3 months, 6 months]
• Physical function: Gait speed (4-meter walking test) [Срок оценки: baseline, 3 months, 6 months]
• Physical function: Gait speed (10-meter walk test) [Срок оценки: baseline, 3 months, 6 months]
• Physical function: Functional lower extremity strength (5 Times Sit to Stand Test) [Срок оценки: baseline, 3 months, 6 months]
• Physical function: Grip strength [Срок оценки: baseline, 3 months, 6 months]
• Physical function: Maximal voluntary isometric contraction [Срок оценки: baseline, 3 months, 6 months]
• Self-reported outcome: Quality of Life (Parkinson Disease Questionnaire-39) [Срок оценки: baseline, 3 months, 6 months]
• Self-reported outcome: Fatigue (Parkinson's Fatigue Scale) [Срок оценки: baseline, 3 months, 6 months]
• Self-reported outcome: Sleep (Scales for Outcomes in Parkinson disease- Sleep, nighttime sleep) [Срок оценки: baseline, 3 months, 6 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Connecticut — Storrs

Публикации

• Earp JE, Colon-Semenza C, LoBuono DL. Considerations for developing a targeted amino acid supplement for people with Parkinson's disease that promotes health while accounting for pathophysiology and medication interference. Nutr Rev. 2023 Jul 10;81(8):1063-1076. doi: 10.1093/nutrit/nuad008. PMID 36809398

Идентификаторы

NCT: NCT07115563 · 25-02-219-910 · B2025-0194

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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