Amino Acid Supplement for Parkinson's Disease

Overseen By Jacob Earp, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: UConn Health

Must be taking: Dopamine replacement

Must not be taking: Dopamine antagonists, Blood thinners

Disqualifiers: Cognitive impairment, Unstable condition, others

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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? 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.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you need to be on a stable dose of your dopamine medication for at least 3 months before joining the trial.

Is the amino acid supplement generally safe for humans, especially those with Parkinson's disease?

The safety of amino acid supplements for Parkinson's disease patients is not well-documented, and many patients are unaware of potential side effects or interactions with medications. It's important to consult a doctor before starting any supplement, as there can be risks, especially with protein intake affecting medication absorption. ^{1 2 3 4 5}

How does the amino acid supplement treatment for Parkinson's disease differ from other treatments?

This amino acid supplement is unique because it is designed to address the specific amino acid imbalances found in people with Parkinson's disease, potentially improving symptoms and reducing interference with levodopa medication. Unlike standard treatments, it focuses on precision nutrition by targeting amino acids that are either deficient or in excess in Parkinson's patients. ^{1 6 7 8 9}

What data supports the effectiveness of the amino acid supplement treatment for Parkinson's disease?

Research suggests that dietary amino acids can affect Parkinson's disease symptoms and the effectiveness of levodopa medication. While some studies indicate that a low-protein diet may improve symptoms, the specific role of amino acid supplements remains unclear, and further research is needed to determine their effectiveness. ^{1 10 11 12 13}

Who Is on the Research Team?

Cristina Colon-Semenza, PT, MPT, PhD

Principal Investigator

University of Connecticut

Jacob Earp, PhD

Principal Investigator

University of Connecticut

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are looking to improve their nutrition without affecting their dopamine medication. Participants must be willing to attend four study visits over a month, consume one of the three supplements provided, and undergo blood tests as well as mood and movement assessments.

Inclusion Criteria

I am 55 years old or older.

I have been diagnosed with Parkinson's disease.

I have been on dopamine replacement medication for over 2 years.

Exclusion Criteria

Any unstable medical condition

I am taking medication that affects dopamine in my brain.

I have been diagnosed with Parkinsonism or atypical Parkinson's Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phone screen and 1 in-person visit

Treatment

Participants attend 4 study visits over 4 weeks, consuming one of three supplements and undergoing assessments

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for any delayed responses via phone calls after each intervention visit

4 weeks

3 phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Amino acid supplement

Trial Overview The trial is testing an amino acid supplement designed for those with Parkinson's against a common whey protein supplement and an inactive placebo. It aims to see if the targeted supplement can enhance nutrition while not interfering with Parkinson's medications.

How Is the Trial Designed?

Group I: Amino acid supplement (AA-S) Experimental Treatment 1 Intervention

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: Whey Protein Supplement (WP-S) Active Control 1 Intervention

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: Isonitrogenous Placebo Supplement (CON-S) Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Dietary influences on the antiparkinsonian response to levodopa. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Protein redistribution diet restores motor function in patients with dopa-resistant "off" periods. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Model-based dietary optimization for late-stage, levodopa-treated, Parkinson's disease patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Considerations for developing a targeted amino acid supplement for people with Parkinson's disease that promotes health while accounting for pathophysiology and medication interference. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Dietary modification of Parkinson's disease. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Use of nutritional supplements in Parkinson's disease patients. [2015]

7. Norway pubmed.ncbi.nlm.nih.gov

[Diet therapy in Parkinson disease]. [2008]

8. England pubmed.ncbi.nlm.nih.gov

L-tryptophan supplementation in Parkinson's disease. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A balanced carbohydrate: protein diet in the management of Parkinson's disease. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Decreased cerebrospinal fluid levels of neutral and basic amino acids in patients with Parkinson's disease. [2019]

11. Austria pubmed.ncbi.nlm.nih.gov

Rotations induced by L-dopa in parkinsonian rats are reduced by an ingestion of amino acids. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Changes in the concentration of amino acids in serum and cerebrospinal fluid of patients with Parkinson's disease. [2022]

13. Ireland pubmed.ncbi.nlm.nih.gov

Increased plasma concentrations of aspartate, glutamate and glycine in Parkinson's disease. [2022]