AzTrials
AzTrials

Parkinson Disease (PD)NCT07115563

Daily Amino Acid Supplementation for People With Parkinson's Disease

A study testing Targeted Amino Acid Supplement in people with Parkinson Disease (PD), run by Cristina Colon-Semenza at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
Targeted Amino Acid Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
31 Oct 2025to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusionary Criteria:

  • Male and Females.
  • 50-80 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.
  • Use of Deep Brain Stimulation.
  • Gastric or Bowel resection surgery.
  • Contraindications to blood draw.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carlos Rehbein, MS contact

860-634-8203

carlos.rehbein@uconn.edu

United States2 sites, 2 recruiting
  • UConn Health

    Farmington, Connecticut, 06030

    Carlos Rehbein, MS, 860-486-1121, carlos.rehbein@uconn.edu

    Bernardo Rodrigues, MD, PhD

    Recruiting
  • University of Connecticut

    Storrs, Connecticut, 06269

    Jacob Earp, MS, 860-486-2671, jacob.earp@uconn.edu

    Carlos Rehbein, carlos.rehbein@uconn.edu

    Recruiting

Other trials in United States

About this study

Official title: Effects of Targeted Amino Acid Supplementation for People With Parkinson's Disease on Amino Acid Profiles and Health Related Markers

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)?

Read more

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.

Read the 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.

Being tested
Targeted Amino Acid Supplement, Control (placebo)
Keywords
Nutrition, Parkinson&#39;s disease, Amino acid supplements
Medical subject headings
Parkinson Disease

What participants receive

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

  • Targeted Amino Acid SupplementDietary supplement

    Blend of the essential amino acids (Leucine \& Tryptophan), a conditionally essential amino acids (Arginine \& Taurine), and non-essential amino acids (Glutamate \& Tyrosine) designed to meet the unique nutritional needs of people with Parkinson's disease (PD).

  • Control (placebo)Dietary supplement

    The inert amino acid (alanine) will serve as an isonitrogenous control.

Study groups in NCT07115563
Study groupRoleWhat they receive
ControlPlacebo comparatorThe inert amino acid (alanine) will serve as an isonitrogenous control.
Receives: Dietary Supplement: Control (placebo)
Targeted Amino Acid SupplementExperimentalBlend of the essential amino acids (Leucine \& Tryptophan), a conditionally essential amino acids (Arginine \& Taurine), and non-essential amino acids (Glutamate \& Tyrosine) designed to meet the unique nutritional needs of people with Parkinson's disease (PD).
Receives: Dietary Supplement: Targeted Amino Acid Supplement

What is being measured

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

  1. Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione)

    Circulating amino acid concentrations will be measured from blood samples using high performance liquid chromatography using a solid phase column specifically designed to test amino acids (e.g. 00F-4435-E0, Phenomenex, USA) along with appropriate column guards (e.g. AJ0-7597 \& KJ0-4282, Phenomenex, USA) and liquid phases. This analysis will be performed at the Laboratory of Mass Spectroscopy and Omics Analysis.

    Measured: Baseline, 3 months, and 6 months

  2. Oxidative stress

    Oxidative stress will be measured using a total antioxidant power test (e.g. ab65329, ABCAM, USA). It is a quantitative bioassay and will be performed using the laboratory facilities.

    Measured: Baseline, 3 months, 6 months

  3. Oxidative stress

    Oxidative stress will be assessed with reduced/oxidized glutathione assays (e.g. ab138881, ABCAM, USA). It is a quantitative bioassay and will be assessed using laboratory facilities.

    Measured: Baseline, 3 months, and 6 months

Secondary outcomes (19)
  1. Body composition: Bioelectrical impedance

    Body composition will be assessed using a multi-spectral bioelectrical impedance (Mediana i55, Mediana, South Korea). During this test participants will clean their feet and hands using a sanitary wipe and then stand barefoot on the impedance machine while holding two electrodes. Then a small and imperceivable multi-spectral electrical current will be sent between limbs which the machine will use to estimate the fat content and distribution based on the resistance (i.e., impedance) of this current.

    Measured: Baseline, 3 months, 6 months

  2. Body composition: Ultrasound & Shear Wave Elastography (Tissue Organization & Fibrosis)

    A trained (>20 hr. logged research scanning) ultrasound researcher will use an ultrasound (ACUSON Sequoia, Siemens Healthineers, USA) to assess muscle thickness of the primary knee extensors (quadriceps femoris) and the plantar flexors (gastrocnemius and soleus) as well as their tendons. Longitudinal panoramic 2D ultrasound will be used to measure muscle fascicle length and angle of each muscle. To assess tissue composition of these muscles shear-wave elastography will be used to measure localized muscle stiffness based on propagation of a concentrated acoustic shear (push-pull) wave applied to the center of the muscle.

    Measured: Baseline, 3 months, 6 months

  3. Physical function: Physical activity

    Participants will be sent a research-grade activity monitor, Actigraph GT9X device, in the standard mail at their residence. After receiving the device, participants will engage in a telephone or virtual meeting with a research assistant to learn how to use the device. (approximately 30-40 minutes). Participants will be asked to wear the activity monitor for 7 days prior to the first baseline visit. They will be asked to continuously wear the device on their wrist for the 7 days. Participants will return the device in a pre-paid envelope. The same procedure will occur at the conclusion of the intervention for a post-intervention assessment.

    Measured: 7 days prior to baseline visit and 7 days after the 6-month visit

  4. Physical function: Balance (Mini Balance Evaluation System Test)

    This test assesses balance impairments across 14 items consisting of dynamic balance, anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. The total score ranges from 0 to 28, with each item scored on a scale from 0 to 2 with higher scores indicating better balance.

    Measured: baseline, 3 months, 6 months

  5. Physical function: Gait speed (4-meter walking test)

    This physical test measures the speed at which a person can walk for 4 meters which is related to overall functional ability. The patient is asked to walk at normal speed for 4 meters, while the evaluator records the time required for it. The gait speed is calculated dividing the distance (4m) by the time completed by the participant. The fastest of 2 trials is then recorded.

    Measured: baseline, 3 months, 6 months

  6. Physical function: Gait speed (10-meter walk test)

    This test measures the speed at which a person can walk for 10 meters. The participant will walk for 10 meters, divided by 2 initial meters of acceleration and 2 final meters for deacceleration. The walking speed during the central 6 meters is then recorded.

    Measured: baseline, 3 months, 6 months

  7. Physical function: Functional lower extremity strength (5 Times Sit to Stand Test)

    The Five Times Sit to Stand Test is a physical test for measuring functional strength in the lower limbs. For this test, the participant must stand up and sit down on an armless chair with their arms crossed on their chest as fast as possible 5 times. A practice trial is permitted before the test trial.

    Measured: baseline, 3 months, 6 months

  8. Physical function: Grip strength

    Bilateral grip strength will be assessed with the use of a handheld dynamometer. For this test the participant must be seated on a chair, with the assessed limb at 90º of elbow flexion and holding the dynamometer in a neutral wrist position. Two sub-maximal trials at 50% and 70% of the Maximal voluntary Isometric grip contraction will be performed as a warmup. Then, 3 maximal trials separated by 1 minute of rest will be performed. If there is a 5% or bigger difference in strength for any trial, a fourth attempt must be completed. The highest value obtained for each limb is recorded.

    Measured: baseline, 3 months, 6 months

  9. Physical function: Maximal voluntary isometric contraction

    In these tests participants will be seated in an isometric dynamometer (Biodex System 4, Biodex, USA) with their body and dynamometers positioned according to manufacturer instructions. In these positions participants will perform three submaximal practice isometric contractions (~25%, 50%, and 75% maximal effort) and then 5 maximal effect isometric contractions with each contraction separated 1 min of rest.

    Measured: baseline, 3 months, 6 months

  10. Self-reported outcome: Quality of Life (Parkinson Disease Questionnaire-39)

    This questionnaire assesses the difficulties that people with PD experience across 8 dimensions of daily living; Activities of Daily Living, Attention \& Working Memory, Cognition, Communication, Depression, Functional Mobility, Quality of Life, Social Relationships and Social Support. The score ranges from 0-100 with higher scores indicating worse quality of life.

    Measured: baseline, 3 months, 6 months

  11. Self-reported outcome: Fatigue (Parkinson's Fatigue Scale)

    This is a 16-Item patient-rated questionnaire that quantifies fatigue in people with PD. The scores range from 16 to 80 with higher scores indicating higher levels of fatigue.

    Measured: baseline, 3 months, 6 months

  12. Self-reported outcome: Sleep (Scales for Outcomes in Parkinson disease- Sleep, nighttime sleep)

    This is a patient-reported questionnaire that assess nighttime sleep across 5 items in patients with Parkinson's disease. The score ranges from 0-15 with higher scores indicating worse sleep.

    Measured: baseline, 3 months, 6 months

  13. Self-reported outcome: Sleep (Scales for Outcomes in Parkinson disease- Sleep, daytime sleepiness)

    This is a patient-reported questionnaire that assess daytime sleepiness across 6 items in patients with Parkinson's disease. The score ranges from 0-18 with higher scores indicating more daytime sleepiness.

    Measured: Baseline, 3 months, 6 months

  14. Self-reported outcome: Sleep (Scales for Outcomes in PD-Sleep, Global sleep quality)

    This is a patient-reported questionnaire that assess the individual's global assessment of nighttime sleep with one item in patients with Parkinson disease. The score ranges from 0-6 with higher scores indicating worse global sleep quality.

    Measured: Baseline, 3 months, 6 months

  15. Self-reported outcome: Mood (Profile of Mood State)

    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. The score ranges from -30 to 200 with higher scores indicating worse mood.

    Measured: baseline, 3 months, 6 months

  16. Self-reported outcome: Anxiety (Beck Anxiety Inventory)

    This is an assessment of somatic and cognitive symptoms of anxiety. It consists of 21 items in the form of self-reported questionnaire. The score ranges from 0-63 with higher scores indicating higher levels of anxiety.

    Measured: baseline, 3 months, 6 months

  17. Self-reported outcome: Motivation (Behavioral Regulation in Exercise Questionnaire-2)

    This is the most used measure of motivators for exercise. It is a 19-item survey that evaluates the stages of motivation to exercise. This includes amotivation, external regulation, introjected regulation, identified regulation, and intrinsic regulation. The score ranges from -24 to +20 with higher scores indicating increased motivation.

    Measured: baseline, 3 months, 6 months

  18. Self-reported outcome: Depression (Geriatric Depression Scale-short form)

    This is a 15-item self-report measure of depression in older adults. Scores range from 0-15 with higher scores indicating more severe depression.

    Measured: baseline, 3 months, 6 months

  19. Insulin sensitivity

    Blood drawn will be used to analyze blood glucose. A test strip will be inserted into a glucose meter and a small sample of blood will be applied. The blood glucose level will be recorded.

    Measured: baseline, 3 months, 6 months

Timeline

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

  1. First posted11 Aug 2025
  2. Study start31 Oct 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

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
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07115563
Sponsor's protocol ID
25-02-219-910
Other IDs
B2025-0194
Status last verified
Aug 2026
First submitted
29 Jul 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication

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 study testing Targeted Amino Acid Supplement in people with Parkinson Disease (PD), run by Cristina Colon-Semenza at 2 sites 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?

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: looking for participants now, 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 2 sites 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Carlos Rehbein, MS (860-634-8203, carlos.rehbein@uconn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amino Acid bioavailability (Lysine, Tryptophan, Arginine, Glutamate, Leucine, Taurine, Glutathione) (time frame: Baseline, 3 months, and 6 months). The study lists 3 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 NCT07115563, 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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in