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Thymogen

Glu-Trp, EW dipeptide, Oglufanide, L-Glutamyl-L-tryptophan

Quick Stats
Studies 94
Trials 51
Recruiting NA INTERVENTIONAL NCT07115563

Daily Amino Acid Supplementation for People With Parkinson's Disease

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

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

Name: Targeted Amino Acid Supplement
Type: DIETARY_SUPPLEMENT
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).
Name: Control (placebo)
Type: DIETARY_SUPPLEMENT
Description: The inert amino acid (alanine) will serve as an isonitrogenous control.

Primary Outcomes

Measure: Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione)
TimeFrame: Baseline, 3 months, and 6 months
Description: 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.
Measure: Oxidative stress
TimeFrame: Baseline, 3 months, 6 months
Description: 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.
Measure: Oxidative stress
TimeFrame: Baseline, 3 months, and 6 months
Description: 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.

Trial Information

NCT ID

NCT07115563

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Cristina Colon-Semenza

Last Updated

December 15, 2025