Menu
Recruiting NCT07115563

Daily Amino Acid Supplementation for People With Parkinson's Disease

No phase Interventional Parkinson Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Targeted Amino Acid Supplement, Control (placebo).
Who it may be relevant to
Registry conditions: Parkinson Disease (PD). Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione) [Time frame: Baseline, 3 months, and 6 months]
  • Oxidative stress [Time frame: Baseline, 3 months, 6 months]
  • Oxidative stress [Time frame: Baseline, 3 months, and 6 months]
Secondary outcome measures (12)
  • Body composition: Bioelectrical impedance [Time frame: Baseline, 3 months, 6 months]
  • Body composition: Ultrasound & Shear Wave Elastography (Tissue Organization & Fibrosis) [Time frame: Baseline, 3 months, 6 months]
  • Physical function: Physical activity [Time frame: 7 days prior to baseline visit and 7 days after the 6-month visit]
  • Physical function: Balance (Mini Balance Evaluation System Test) [Time frame: baseline, 3 months, 6 months]
  • Physical function: Gait speed (4-meter walking test) [Time frame: baseline, 3 months, 6 months]
  • Physical function: Gait speed (10-meter walk test) [Time frame: baseline, 3 months, 6 months]
  • Physical function: Functional lower extremity strength (5 Times Sit to Stand Test) [Time frame: baseline, 3 months, 6 months]
  • Physical function: Grip strength [Time frame: baseline, 3 months, 6 months]
  • Physical function: Maximal voluntary isometric contraction [Time frame: baseline, 3 months, 6 months]
  • Self-reported outcome: Quality of Life (Parkinson Disease Questionnaire-39) [Time frame: baseline, 3 months, 6 months]
  • Self-reported outcome: Fatigue (Parkinson's Fatigue Scale) [Time frame: baseline, 3 months, 6 months]
  • Self-reported outcome: Sleep (Scales for Outcomes in Parkinson disease- Sleep, nighttime sleep) [Time frame: baseline, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Connecticut — Storrs

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗