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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Targeted Amino Acid Supplement
Dietary supplementBlend 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 supplementThe inert amino acid (alanine) will serve as an isonitrogenous control.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Cristina Colon-Semenza
Lead sponsor
University of Connecticut
Sponsor institution
United States Department of Agriculture (USDA)
Collaborator