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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new amino acid supplement designed for people with Parkinson's disease to determine if it improves nutrition without affecting their usual medication. The study compares this specialized supplement to a common whey protein supplement and a placebo (inactive supplement) to assess changes in nutrition levels, mood, and movement. Participants will attend four study visits over four weeks and consume one of the supplements at each visit. The trial seeks individuals who have had Parkinson's disease for at least two years and are on stable dopamine medication. As an Early Phase 1 trial, this research aims to understand how the new supplement works in people, offering participants a chance to be among the first to try this innovative approach.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that amino acid supplements can be safe for people with Parkinson's disease. In previous studies, patients who took these supplements experienced no negative effects on brain or nerve function, nor did it interfere with their medication. This indicates that the supplements were generally well-tolerated.

One study examined whey protein, a key component of the amino acid supplement, and found it safe for people with Parkinson's disease. There was no noticeable increase in disease symptoms, which supports its safety.

While the current trial remains in the early stages, these findings suggest that the amino acid supplement could be safe for people. However, more information from ongoing research will help confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the amino acid supplement for Parkinson's Disease because it offers a unique approach compared to standard treatments like levodopa, which mainly focus on replenishing dopamine. This supplement is specially formulated to minimize interference with levodopa by reducing certain amino acids that compete with it, while also addressing nutritional deficiencies commonly seen in Parkinson's patients. By targeting both medication interaction and nutritional support, this treatment could potentially enhance the effectiveness of existing therapies and improve overall patient health.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research has shown that amino acid supplements might aid people with Parkinson's disease by enhancing nutrition without disrupting their medication. Some studies suggest these dietary amino acids can influence Parkinson's symptoms and the effectiveness of levodopa, a common Parkinson's medication. In this trial, participants may receive an amino acid supplement specifically designed to reduce amino acids that might interfere with levodopa and increase those often needed by people with Parkinson's. Although more research is necessary, early results suggest these changes can help maintain balanced nutrition and might support overall well-being in people with Parkinson’s. ^{1 3 5 6 7}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07115563

Daily Amino Acid Supplementation for People With ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36809398/

Considerations for developing a targeted amino acid ... Considerations for the development of a precision nutritional supplement that targets AAs specific to the needs of people with PD are discussed.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561414003057

Amino acid supplementation in l-dopa treated Parkinson's ... Participants were comparable at baseline for all assessed parameters. Neurological outcomes and l-dopa requirement were comparable in both group after 6-month ...

4. withpower.com withpower.com/trial/amino-acid-supplement-for-parkinsons-disease-65065

Amino Acid Supplement 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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06954662

Study Details | NCT06954662 | A Targeted Amino Acid ... This study validated the safety and efficacy of whey protein supplementation in people with Parkinson's Disease, but a non-significant increase in disease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3068871/

Amino acid management of Parkinson's disease: a case study While this is a case study report, the authors of this paper possess data on the amino acid dosing needs of over 254 Parkinson's patients who have been treated ...

7. ctv.veeva.com ctv.veeva.com/study/a-targeted-amino-acid-supplement-for-people-with-parkinsons-disease

A Targeted Amino Acid Supplement for People With ... This study validated the safety and efficacy of whey protein supplementation in people with Parkinson's Disease, but a non-significant increase ...