Daily Amino Acid Supplementation for People With Parkinson's Disease
Part of paid clinical trials in Storrs, Connecticut.
- Sponsor
- Cristina Colon-Semenza
- Study ID
- NCT07115563
- Status
- Recruiting
Conditions
- Parkinson Disease (PD)
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Targeted Amino Acid Supplement — DIETARY_SUPPLEMENTBlend 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) — DIETARY_SUPPLEMENTThe inert amino acid (alanine) will serve as an isonitrogenous control.
Study Details
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.
Key Dates
- Start date
- Oct 31, 2025
- Status verified
- Nov 2025
- Primary completion
- Sep 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Placebo Comparator: ControlThe inert amino acid (alanine) will serve as an isonitrogenous control.
- Experimental: Targeted Amino Acid SupplementBlend 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).
Primary Outcome Measure
Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione) [ Time Frame: Baseline, 3 months, and 6 months ]
Central Contacts
- Carlos Rehbein, MS860-486-1121
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | Carlos Rehbein Jacob Earp, PhD (PRINCIPAL_INVESTIGATOR) Cristina Colon-Semenza, PT, MPT, PhD (PRINCIPAL_INVESTIGATOR) |
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