NCT07115563 · Cristina Colon-Semenza
Daily Amino Acid Supplementation for People With Parkinson's Disease
What this study is about
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.
View original scientific description
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.
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
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
Time frame: 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.
Oxidative stress
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ary 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.
Exclusion criteria
- ary 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.
Where
- Farmington, Connecticut
- Storrs, Connecticut
Collaborators
United States Department of Agriculture (USDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2026 · Source of record for eligibility and locations