Daily Amino Acid Supplementation for People With Parkinson's Disease
NCT ID: NCT07115563
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-10-31
2027-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Control
The inert amino acid (alanine) will serve as an isonitrogenous control.
Control (placebo)
The inert amino acid (alanine) will serve as an isonitrogenous control.
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).
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
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
60 Years
80 Years
ALL
No
Sponsors
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United States Department of Agriculture (USDA)
FED
Cristina Colon-Semenza
OTHER
Responsible Party
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Cristina Colon-Semenza
Assistant Professor
Locations
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University of Connecticut
Storrs, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Jacob Earp, MS
Role: primary
Carlos Rehbein
Role: backup
References
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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.
Other Identifiers
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B2025-0194
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
25-02-219-910
Identifier Type: -
Identifier Source: org_study_id