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NCT07115563 | RECRUITING | Parkinson Disease (PD)

Daily Amino Acid Supplementation for People With Parkinson's Disease
Sponsor:

Cristina Colon-Semenza

Information provided by (Responsible Party):

Cristina Colon-Semenza

Brief Summary:

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.

Condition or disease

Parkinson Disease (PD)

Intervention/treatment

Targeted Amino Acid Supplement

Control (placebo)

Phase

NA

Detailed Description:

The purpose of this trial is to determine the effects of a targeted amino acid supplement (T-AA) specifically designed to correct characteristic amino acid deficiencies and meet the unique nutritional needs of people with Parkinson's disease (PD) on 1) plasma amino acid (AA) bioavailability, 2) metabolic function, 3) body composition, 4) physical function and 5) self-reported outcomes.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
Official Title : Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers
Actual Study Start Date : 2025-10-31
Estimated Primary Completion Date : 2027-09
Estimated Study Completion Date : 2027-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusionary Criteria
  • * Male and Females.
  • * 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.
Daily Amino Acid Supplementation for People With Parkinson's Disease

Location Details

NCT07115563

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How to Participate

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Locations

RECRUITING

United States, Connecticut

University of Connecticut

Storrs, Connecticut, United States, 06269