A Targeted Amino Acid Supplement for People With Parkinson's Disease

NCT06954662 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 24-017S-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if an amino acid supplement that is specifically made for people with Parkinson disease can improve nutrition without interfering with dopamine medication in people living with Parkinson disease. The main question it aims to answer is:

• Does an amino acid supplement that is specifically made for people with Parkinson disease have short-term improvements in nutrition deficiencies, while minimally interfering with Parkinson disease medication? Researchers will compare the short-term effects of this specialized nutrition supplement to a supplement that is available for everyone to purchase in a store (whey protein supplement-a milk by-product) and to an inactive supplement. Researchers will then check for the indicators of nutrition levels and the presence of dopamine medication in the blood. Researchers will also assess mood and movement abilities in participants. Participants will be asked to:
• attend 4 study visits over the course of 4 weeks (initial orientation visit plus 3 intervention visits).
• drink one of the 3 supplements (supplements will be mixed into water to create a beverage) at each of the 3 intervention visits.
• participate in blood drawings and mood and movement assessments at each of the intervention visits.
• engage in a phone call after each intervention visit to determine any delayed responses.

Conditions

Parkinson Disease, Idiopathic

Keywords

Nutrition; Amino acid supplementation; Parkinson disease

Outcome Measures

Primary Outcomes (2)

• Circulating levodopa

  Circulating levodopa will be measured from the 10 blood samples at each of the three study visits.

  study session 2 (Week 2), 3 (Week 3), and 4 (Week 4). Each session will last approximately 3-4 hours.

• Circulating amino acids concentrations

  High performance liquid chromatography will be used to assess amino acid concentrations in blood samples (10) from each intervention session

  Session 2 (Week 2), Session 3 (Week 3), Session 4 (Week 4)

Secondary Outcomes (4)

• Unified Parkinson Disease Rating Scale, Part III

  This test will be performed prior to medication (Pre/+0 minutes) and at the end of testing (+180 minutes) at each of the 3 intervention sessions (Session 2/Week 2, Session 3/Week 3, Session 4/Week 4)

• Timed Up and Go Test

  This test will be performed every 30 minutes (+0, +30, +60, +90, +120, +150, and +180 minutes) at each of the intervention sessions (Session 2/Week 2, Session 3/Week 3, Session 4/Week 4).

• Abbreviated Profile of Mood State

  This test will be performed prior to medication (Pre/+0 minutes) and at the end of testing (+180 minutes) at each intervention session.

• 30 second Finger Tapping

  This test will be performed every 30 minutes (+0, +30, +60, +90, +120, +150, and +180 minutes) at each intervention session

Study Arms (3)

Whey Protein Supplement (WP-S)

ACTIVE COMPARATOR

Whey protein is one of the primary proteins found in all dairy products. It is a complete protein as it contains all the essential amino acids. It is commercially available as a dietary supplement (a standard 20 g dose of whey).

Dietary Supplement: Whey Protein Supplement

Isonitrogenous Placebo Supplement (CON-S)

PLACEBO COMPARATOR

The control supplement used in this study is an isonitrogenous placebo beverage. This supplement will consist of an inert amino acid (alanine) with the same amino acid load as the WP-S and AA-S (16.2 g).

Dietary Supplement: Isonitrogenous Placebo Supplement

Amino acid supplement (AA-S)

EXPERIMENTAL

designed off the amino acid composition of the why protein supplement, but then was modified to minimize interference with levodopa by reducing the quantity of amino acids which are known to interfere with levodopa, which collectively resulted in a 59% reduction in competing amino acids. Additionally, the concentrations of other non-competing amino acids were modified in order to fill the previously identified nutritional deficiency observed in people with PD.

Drug: Amino acid supplement

Interventions

Amino acid supplement DRUG

a targeted amino acid supplement designed to provide dietary nutrients that are commonly deficient in people with PD while minimizing interference with L-Dopa medication

Also known as: AA-S

Amino acid supplement (AA-S)

Whey Protein Supplement DIETARY_SUPPLEMENT

Whey protein is one of the primary proteins found in all dairy products. It is a complete protein as it contains all the essential amino acids. We will use a 20 gram dose.

Also known as: WP-S

Whey Protein Supplement (WP-S)

Isonitrogenous Placebo Supplement DIETARY_SUPPLEMENT

The control supplement used in this study is an isonitrogenous placebo beverage. This supplement will consist of an inert amino acid (alanine) with the same amino acid load as the whey protein and the targeted amino acid supplement (16.2 grams).

Also known as: CON-S

Isonitrogenous Placebo Supplement (CON-S)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of idiopathic Parkinson disease by patient report
• years or older
• Has been using 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.

You may not qualify if:

• Apparent cognitive impairment as determined by phone screening (TICS)
• Diagnosis of Parkinsonism or atypical Parkinson's Disease
• Are prescribed a dopamine antagonist
• Any unstable medical condition
• Any known bleeding disorder or currently taking blood thinners
• Using deep brain stimulation
• Gastric or bowel resection surgery

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health, Clinical Research Center

Farmington, Connecticut, 06030-3805, United States

Location

Related Publications (1)

• 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.

  PMID: 36809398 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Cristina Colon-Semenza, PT, MPT, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

• Jacob Earp, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a prospective, double-blind, randomized control trial with a repeated measures design in a single group.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 1, 2025
• Study Start: May 22, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)