NCT07115563

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

Recruiting now NA Last updated 11 November 2025

What this trial tests

NA trial testing Targeted Amino Acid Supplement in Parkinson Disease (PD) in 30 participants. Currently enrolling.

Timeline

31 October 2025

Primary endpoint
1 September 2027

1 November 2027

Quick facts

Lead sponsor	Cristina Colon-Semenza
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	30
Start date	31 October 2025
Primary completion	1 September 2027
Estimated completion	1 November 2027
Sites	1 location across United States

Drugs / interventions tested

• Targeted Amino Acid Supplement
• Control (placebo)

Conditions studied

• Parkinson Disease (PD) — all drugs for Parkinson Disease (PD) →

Sponsor

Cristina Colon-Semenza

Who can join

Adults 60 to 80, any sex, with Parkinson Disease (PD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.