Effects of a Targeted Amino Acid Supplement on Health and Amino Acid Levels in Adults with Parkinsons Disease Ages 50 to 80
Led by Cristina Colon-Semenza · Updated on 2026-07-02
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a targeted amino acid supplement designed to meet the unique nutritional needs of adults living with Parkinsons disease PD. This study aims to understand whether this supplement can improve amino acid levels, metabolic function, body composition, physical abilities, and mental health. The study compares the tailored amino acid supplement to a placebo to see if it supports better health outcomes in people with PD.
Participants will be randomly assigned to receive either the targeted amino acid blend, which includes essential, conditionally essential, and non-essential amino acids, or a placebo containing an inert amino acid. They will take the assigned supplement daily for six months. The study involves a parallel design with visits at the start, after three months, and at the six-month mark.
During the study, participants will visit the lab three times for fasting blood tests, body composition measurements using bioelectrical impedance and ultrasound, and assessments of physical function like balance, gait speed, strength, and self-reported outcomes such as quality of life, fatigue, sleep, mood, anxiety, motivation, and depression. Researchers will monitor amino acid bioavailability, oxidative stress, insulin sensitivity, and other health markers. Participants will also keep a diary of their food and supplement intake throughout the study.
CONDITIONS
Brief Title
Daily Amino Acid Supplementation for People With Parkinson's Disease
Research Team
C
Carlos Rehbein, MS
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Targeted Amino Acid Supplement
Placebo Control
What it is
A daily blend of essential, conditionally essential, and non-essential amino acids (leucine, tryptophan, arginine, taurine, glutamate and tyrosine) formulated to support nutrition, metabolic function and physical and mental health in people with Parkinson’s disease
An inert isonitrogenous placebo composed of alanine serving as a control supplement
Role in trial
Experimental intervention being tested for effects on bioavailability, oxidative stress, body composition and functional outcomes
Control arm providing a matched supplement without active amino acids to assess efficacy against placebo
Primary use
Studied as a nutritional supplement to improve amino acid levels, oxidative stress markers, body composition, physical function and mental health
Serves as a placebo comparator to control for nonspecific effects
How it is given or performed
Taken orally every day for 6 months, with assessments at baseline, 3 months and 6 months
Taken orally every day for 6 months, with the same assessment schedule as the investigational supplement
Evidence status
No results are yet available—the effects are under investigation and results are pending following trial completion
Placebo has no expected active effect; serves as control and results are pending
Important risks
Not yet established—safety data will be collected during the trial
Not yet established—safety data for placebo arm will be collected during the trial
Important limitations
Small sample size (around 30 participants) and early-stage trial limit generalizability until results are confirmed
Same limitations apply as to investigational arm
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 50Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
Male and female adults aged 50 to 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
Stable dose of dopamine replacement medication for at least 3 months with no planned changes in the next 2 months
You will not qualify if you...
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 medication
Any unstable medical condition
Use of Deep Brain Stimulation
History of gastric or bowel resection surgery
Contraindications to blood draw
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 6 months
Participants take either the targeted amino acid supplement or a placebo daily for six months.
Visits at baseline, 3 months, and 6 months for assessments
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Considerations for developing a targeted amino acid supplement for people with Parkinson's disease that promotes health while accounting for pathophysiology and medication interference.
Jacob E Earp, Cristina Colon-Semenza, Dara L LoBuono