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Daily Amino Acid Supplementation for People With Parkinson's Disease

NCT07115563 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease (PD)

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.

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED

  • Cristina Colon-Semenza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-09-30
Completion
2027-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115563 on ClinicalTrials.gov