Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers
Led by Cristina Colon-Semenza · Updated on 2025-11-13
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Participants Needed
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8 weeks
Total Duration
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C
Cristina Colon-Semenza
Lead Sponsor
U
United States Department of Agriculture (USDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a specially designed amino acid supplement can help adults with Parkinson's disease improve their nutrition, metabolism, body composition, and physical and mental health. The study aims to see if this tailored supplement increases key essential amino acids and antioxidants, reduces harmful amino acids linked to oxidative stress, and improves overall health compared to a placebo. The trial focuses on people aged 60 to 80 years who have Parkinson's disease and are on stable dopamine replacement therapy.
Participants will be randomly assigned to take either the targeted amino acid supplement or an inactive placebo containing alanine daily for six months. The supplement includes a blend of essential, conditionally essential, and non-essential amino acids chosen to meet the unique nutritional needs of people with Parkinson's disease. The study is designed as a quadruple-blind trial, meaning neither participants nor researchers know who receives the supplement or placebo during the study.
During the trial, participants will visit the lab at the start, after three months, and after six months for fasting blood tests to measure amino acid levels and oxidative stress. Their body composition will be assessed using bioelectrical impedance and ultrasound techniques. Physical function tests such as balance, walking speed, strength, and grip will be conducted, along with questionnaires on quality of life, fatigue, sleep, mood, anxiety, motivation, and depression. Physical activity will be monitored before and after the study, and insulin sensitivity will also be evaluated. Participants will keep diaries of their food and supplement intake throughout the six months.
CONDITIONS
Brief Title
Daily Amino Acid Supplementation for People With Parkinson's Disease
Who Can Participate
Age: 60Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
Male and female adults aged 60 to 80 years
Previous diagnosis of idiopathic Parkinson's Disease by patient report
Use of dopamine replacement medication for at least 2 years
On a stable dose of dopamine replacement medication for at least 3 months with no planned changes in the next two months
You will not qualify if you...
Apparent cognitive impairment as determined by phone screening
Diagnosis of Parkinsonism or atypical Parkinson's Disease
Prescription of dopamine antagonist medication
Any unstable medical condition
Known bleeding disorder or current use of blood thinners
Use of Deep Brain Stimulation
History of gastric or bowel resection surgery
Contraindications to blood draw
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants take a targeted amino acid supplement or placebo daily to assess effects on amino acid profiles and health markers.
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