Daily Amino Acid Supplementation for People With Parkinson's Disease

Cristina Colon-Semenza

Status: Enrolling

Conditions: Parkinson Disease (PD)

Treatments: Dietary Supplement: Targeted Amino Acid Supplement; Dietary Supplement: Control (placebo)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07115563

B2025-0194 (Other Grant/Funding Number)

25-02-219-910

Details and patient eligibility

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. 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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusionary Criteria:

• Male and Females.
• 60-80 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.
• Any known bleeding disorder or current consumption of blood thinners.
• Use of Deep Brain Stimulation.
• Gastric or Bowel resection surgery.
• Contraindications to blood draw.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The inert amino acid (alanine) will serve as an isonitrogenous control.

Treatment:

Dietary Supplement: Control (placebo)

Targeted Amino Acid Supplement

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Targeted Amino Acid Supplement