Recruiting

Amino Acid Supplement

Sponsor:

Cristina Colon-Semenza

Code:

NCT07115563

Conditions

Parkinson Disease (PD)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Targeted Amino Acid Supplement

Control (placebo)

Study Details

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)

Study ID

NCT07115563

Start date

Oct 31, 2025

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusionary Criteria:

  • Male and Females.
  • 50-80 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.
  • Use of Deep Brain Stimulation.
  • Gastric or Bowel resection surgery.
  • Contraindications to blood draw.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Control

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

experimental: 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).

Interventions

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).

Control (placebo)

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

Primary outcome measure

  • Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione) [ Time Frame: Baseline, 3 months, and 6 months ]
  • Oxidative stress [ Time Frame: Baseline, 3 months, 6 months ]
  • Oxidative stress [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts and Locations

Central contacts

Locations

UConn Health

Recruiting

Farmington, Connecticut, United States, 06030

Contacts

University of Connecticut

Recruiting

Storrs, Connecticut, United States, 06269

Contacts

Principal Investigator:

Jacob Earp, PhD

More Information

Sponsor

Cristina Colon-Semenza

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Nutrition
  • Parkinson&#39;s disease
  • Amino acid supplements

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cristina Colon-Semenza on 2026-08-13.