Actively Recruiting

Phase Not Applicable
Age: 60Years - 80Years
All Genders
ID07115563

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

30

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

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

Eligible

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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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.

Visits at baseline, 3 months, and 6 months

Trial Site Locations

Total: 1 location

1

University of Connecticut

Storrs, Connecticut, United States, 06269

Actively Recruiting

Loading map...

Research Team

C

Carlos Rehbein, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evalu...

Parkinson Disease (PD)

Actively Recruiting

1 location

Clinical Research on Optimization of Acute Levodopa Challeng...

Vascular Parkinsonism

Actively Recruiting

1 location

Changes in Motor Function, Quality of Life, Cardiorespirator...

Parkinson Disease (PD)

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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

https://pubmed.ncbi.nlm.nih.gov/36809398