Daily Amino Acid Supplementation for People With Parkinson's Disease

NCT07115563 | Recruiting

• 2 other identifiers: 25-02-219-910B2025-0194
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease (PD)

Keywords

Nutrition; Parkinson's disease; Amino acid supplements

Outcome Measures

Primary Outcomes (3)

• Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione)

  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.

  Baseline, 3 months, and 6 months

• Oxidative stress

  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.

  Baseline, 3 months, 6 months

• Oxidative stress

  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.

  Baseline, 3 months, and 6 months

Secondary Outcomes (19)

• Body composition: Bioelectrical impedance

  Baseline, 3 months, 6 months

• Body composition: Ultrasound & Shear Wave Elastography (Tissue Organization & Fibrosis)

  Baseline, 3 months, 6 months

• Physical function: Physical activity

  7 days prior to baseline visit and 7 days after the 6-month visit

• Physical function: Balance (Mini Balance Evaluation System Test)

  baseline, 3 months, 6 months

• Physical function: Gait speed (4-meter walking test)

  baseline, 3 months, 6 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Control (placebo)

Targeted Amino Acid Supplement

EXPERIMENTAL

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: Targeted Amino Acid Supplement

Interventions

Targeted Amino Acid Supplement DIETARY_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).

Targeted Amino Acid Supplement

Control (placebo) DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cristina Colon-Semenza: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

RECRUITING

Related Publications (1)

• Earp JE, Colon-Semenza C, LoBuono DL. Considerations for developing a targeted amino acid supplement for people with Parkinson's disease that promotes health while accounting for pathophysiology and medication interference. Nutr Rev. 2023 Jul 10;81(8):1063-1076. doi: 10.1093/nutrit/nuad008.

  PMID: 36809398 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Carlos Rehbein, MS

CONTACT

860-486-1121; carlos.rehbein@uconn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 11, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 1 year after publication and ending 3 years after the publication of results
• Access Criteria: A proposal for planned analyses must be submitted, a data sharing agreement must be signed, and documents must be submitted to the PIs, Dr. Earp and Dr. Colón-Semenza via email. Requests will be reviewed by the PIs to determine eligibility. Eligible individuals must have expertise in Parkinson disease, nutrition, and/or oxidative stress and antioxidant capacity, and have a position at a research institution with a dissemination plan of making their results publicly available through peer-reviewed publications. This data will not be shared with commercial entities.

Locations

US (1)