Suspended

Whey Protein and Amino Acid Supplements for Amino Acid and Levodopa Levels in Parkinson's Disease

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What is being tested

Amino acid supplement

+ Whey Protein Supplement

+ Isonitrogenous Placebo Supplement

DrugDietary Supplement
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

Over 55 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorUConn Health
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 22, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring the effects of different protein and amino acid supplements on people with Parkinson's Disease who are taking levodopa, a common medication for this condition. The goal is to understand how these supplements affect the levels of amino acids and levodopa in the blood, and how they might influence symptoms of the disease. Participants are individuals with Parkinson's Disease who are already on a stable dose of their medication. This research is important as it could help optimize dietary recommendations and medication management for people with Parkinson's Disease, potentially improving their quality of life. Participants will take part in three different sessions where they will consume either a whey protein supplement, a specially formulated amino acid supplement, or a placebo beverage, all given orally. Blood samples will be collected at various intervals to measure the levels of levodopa and amino acids. The study will also assess changes in both movement-related and mood-related symptoms to see how these are affected by the different supplements. The supplements are provided in a way that keeps both the participants and the researchers unaware of which supplement is being taken, ensuring unbiased results.

Official TitleComparison of Whey Protein and Amino Acid Supplementation on Amino Acid and Levodopa Concentrations in People With Parkinson's Disease
NCT06954662
Principal SponsorUConn Health
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

4 inclusion criteria required to participate
On a stable dose of dopamine replacement medication for at least 3 months with no plans for change in the next two months.
diagnosis of idiopathic Parkinson disease by patient report
55 years or older
Has been using dopamine replacement medication (e.g. levodopa) for at least 2 years.
7 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

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).

Group III

Placebo
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UConn Health, Clinical Research Center

Farmington, United StatesOpen UConn Health, Clinical Research Center in Google Maps
SuspendedOne Study Center