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Parkinson Disease, IdiopathicEarly Phase 1NCT06954662

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

A Early Phase 1 study testing Amino acid supplement and Whey Protein Supplement in people with Parkinson Disease, Idiopathic, run by UConn Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Parkinson Disease, Idiopathic
What is being tested?
Amino acid supplement and Whey Protein Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
22 May 2025to 17 Jul 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • On a stable dose of dopamine replacement medication for at least 3 months with no plans for change in the next two months.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UConn Health, Clinical Research Center

    Farmington, Connecticut, 06030-3805

Other trials in United States

About this study

Official title: Comparison of Whey Protein and Amino Acid Supplementation on Amino Acid and Levodopa Concentrations in People With Parkinson's Disease

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?
Read more

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.
Read the detailed description

This is a prospective, double-blind, randomized control trial with a repeated measures design. After being screened via phone screens and completing an initial visit that includes additional in person screening and the collection of descriptive information, participants will be invited to take part in three experimental sessions. On three separate days participants with idiopathic Parkinson's Disease and taking a stable dose of dopamine replacement medication, 2-3 hours after a standardized low-protein meal, will orally take a habitual dose of L-Dopa medication and then engage in one of the three interventions 1) WP-S: whey protein supplement (20 g), 2) AA-S: targeted amino acid supplement (equivalent amino acid load to whey protein beverage) 3) CON-S: an isonitrogenous placebo beverage (equivalent amino acid load to whey protein beverage), prescribed in a randomized and counterbalanced manner. Prior to, and up to 3 hours after medication, blood samples will be collected every 15 min for 90 min and every 30 min thereafter and then analyzed to determine circulating L-dopa and amino acid profiles using high-performance liquid chromatography. During this observation period changes in both motor (Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part 3 (MDSUPDRS III), finger tapping, and Timed Up and Go Test) and non-motor disease symptoms (Profile of Mood State with component analysis of depression, fatigue, and anxiety) will be measured every 30 minutes.

All supplements will be provided for the study in coded prepackaged envelopes by an independent nutritional supplement company based on the formulas provided below, to ensure double blinding.

Whey Protein Supplement (WP-S): 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. A previous investigation has been performed looking at the long -term (6 months) effects of whey protein supplementation on health and disease symptoms of people with Parkinson's Disease. This study validated the safety and efficacy of whey protein supplementation in people with Parkinson's Disease, but a non-significant increase in disease symptoms (during medication off time) was reported. Similar to this previous study, we will use a standard 20 g dose of whey protein.

Targeted Amino Acid Supplement (AA-S): Previous studies have investigated the long-term (6 months) effects of amino acid supplementation on health and disease symptoms of people with Parkinson's Disease. The previous whey protein study, and the previous amino acid supplement study, validated the safety and efficacy of an amino acid supplement in people with Parkinson's Disease but a non-significant increase in disease symptoms (during medication off time) was reported. However, the supplement in these studies was not designed to minimize the components which could interfere with levodopa medication.

In contrast, the AA-S used in the present study was designed off the amino acid composition of WP-S, but then was modified to minimize interference with levodopa by reducing the quantity of amino acids which are known to interfere with levodopa (large neutral amino acids), 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.

Isonitrogenous Placebo Supplement (CON-S): 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).

Being tested
Amino acid supplement, Whey Protein Supplement, Isonitrogenous Placebo Supplement
Keywords
Nutrition, Amino acid supplementation, Parkinson disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amino acid supplementDrug

    Also called AA-S

    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

  • Whey Protein SupplementDietary supplement

    Also called WP-S

    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.

  • Isonitrogenous Placebo SupplementDietary supplement

    Also called CON-S

    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).

Study groups in NCT06954662
Study groupRoleWhat they receive
Whey Protein Supplement (WP-S)Active comparatorWhey 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).
Receives: Dietary Supplement: Whey Protein Supplement
Isonitrogenous Placebo Supplement (CON-S)Placebo comparatorThe 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).
Receives: Dietary Supplement: Isonitrogenous Placebo Supplement
Amino acid supplement (AA-S)Experimentaldesigned 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.
Receives: Drug: Amino acid supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circulating levodopa

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

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

  2. Circulating amino acids concentrations

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

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

Secondary outcomes (4)
  1. Unified Parkinson Disease Rating Scale, Part III

    Disease motor symptoms will be assessed via Part 3 of the UPDRS. Research staff that have completed training to administer and grade this test by the International Parkinson and Movement Disorder Society will complete this assessment. This portion of the UPDRS is designed to test motor symptoms related to Parkinson's Disease. The test includes quick clinical assessments of passive rigidity, finger and toe tapping, hand and forearm movement, chair standing, gait (10 meter) assessment, and postural assessment.

    Measured: 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)

  2. Timed Up and Go Test

    The timed up and go test will be performed as an additional physical symptom assessment. In this test the participant will start in a seated position, then stand up, walk 3 meters and then turn around and return to the chair.

    Measured: 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).

  3. Abbreviated Profile of Mood State

    Abbreviated Profile of Mood States (POMS) Questionnaire: This an assessment of current mood state. It is a 40-item self-report survey that evaluates the degree to which a participant is feeling a selected emotion at the moment.

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

  4. 30 second Finger Tapping

    The 30 second finger tapping test is an assessment of fine motor control. The participant will sit upright in a chair with their most affected (with the greatest disease symptoms) hand positioned over a tablet. In this position the participant will tap the screen as many times as they can for 30 seconds, and the total number of taps will be recorded.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start22 May 2025
  3. Primary completion17 Jul 2025
  4. Study completion17 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
This is a prospective, double-blind, randomized control trial with a repeated measures design in a single group.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06954662
Sponsor's protocol ID
24-017S-1
Status last verified
Aug 2026
First submitted
28 Mar 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The funding for reviewing requests, storing and managing data, and sharing IPD is undetermined at this time.

Publications

  • 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.

    PubMed 36809398

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Amino acid supplement and Whey Protein Supplement in people with Parkinson Disease, Idiopathic, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating levodopa (time frame: study session 2 (Week 2), 3 (Week 3), and 4 (Week 4). Each session will last approximately 3-4 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06954662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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