Daily Amino Acid Supplementation for People With Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorCristina Colon-Semenza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Targeted Amino Acid Supplement

    Dietary 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: Targeted Amino Acid SupplementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Baseline, 3 months, and 6 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
baseline, 3 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cristina Colon-Semenza

Lead sponsor

University of Connecticut

Sponsor institution

United States Department of Agriculture (USDA)

Collaborator