Amino Acid Supplement for Parkinson's Disease

Overseen By Carlos Rehbein, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cristina Colon-Semenza

Must be taking: Dopamine replacement

Must not be taking: Dopamine antagonists, Blood thinners

Disqualifiers: Cognitive impairment, Unstable conditions, others

Compensation: Varies

Number of Visits: 3

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a special amino acid supplement can benefit people with Parkinson's disease. Researchers aim to determine if this targeted supplement can enhance nutrition, body health, and mental well-being. Participants will take either the supplement or a placebo (a look-alike substance with no active ingredients) for six months. It suits those who have used dopamine replacement medication, such as levodopa, for at least two years. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve the quality of life for Parkinson's patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a stable dose of dopamine replacement medication for at least 3 months and have no plans to change it in the next two months.

What prior data suggests that this amino acid supplement is safe for people with Parkinson's disease?

Research has shown that amino acid supplements can be safe for people with Parkinson's disease. One study examined whey protein, a similar supplement, and found it was generally well-tolerated, with no major safety concerns. Another source mentions that specific amino acid supplements are being tested for safety in Parkinson's patients, suggesting that researchers believe any side effects might be manageable.

The amino acids in the supplement—such as leucine, arginine, and glutamate—are either essential (needed for health) or non-essential (the body can produce them). These amino acids aim to meet the unique nutritional needs of people with Parkinson's. Although specific data on the exact supplement in this trial is not available, existing research suggests it should be safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Parkinson's disease, which often include medications like Levodopa and dopamine agonists aimed at managing symptoms by boosting dopamine levels, this targeted amino acid supplement offers a novel approach. This treatment is designed specifically to address the unique nutritional needs of individuals with Parkinson's by providing a blend of both essential and non-essential amino acids, including Leucine, Tryptophan, Arginine, Taurine, Glutamate, and Tyrosine. Researchers are excited about this treatment because it represents a shift towards nutritional support, potentially offering a complementary strategy to enhance overall health and well-being in Parkinson's patients, beyond just symptom control.

What evidence suggests that this amino acid supplement might be an effective treatment for Parkinson's disease?

Research has shown that specific amino acid supplements might aid people with Parkinson's disease by enhancing nutrition and body function. In this trial, participants will receive a targeted amino acid supplement tailored to the unique nutritional needs of individuals with Parkinson's disease. One study found a strong connection between amino acid levels and diseases like Parkinson's, suggesting that managing amino acids could positively affect the condition. Another study examined how amino acids might alleviate issues caused by common Parkinson's treatments. These findings suggest that amino acid supplements could improve both physical and mental health in people with Parkinson's. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with Parkinson's Disease who are interested in whether a daily amino acid supplement can improve their nutrition, metabolism, body composition, and overall physical and mental health. Participants will be required to take the supplement or placebo daily for 6 months and attend lab visits.

Inclusion Criteria

I am between 60 and 80 years old.

I am either male or female.

I've been on a steady dose of dopamine medication for 3 months with no changes expected soon.

Exclusion Criteria

I have had surgery to remove part of my stomach or intestines.

I have a bleeding disorder or am currently taking blood thinners.

Apparent cognitive impairment as determined by phone screening (Telephone Interview for Cognitive Status <29)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take the tailored amino acid supplement or a placebo every day for 6 months

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Amino Acid Supplement

Trial Overview Researchers are testing if a tailored amino acid supplement can boost essential amino acids, increase antioxidants, reduce oxidative stress markers, and enhance physical and mental health in Parkinson's patients compared to a placebo over six months.

How Is the Trial Designed?

Group I: Targeted Amino Acid Supplement Experimental Treatment 1 Intervention

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).

Group II: Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Cristina Colon-Semenza

Lead Sponsor

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

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. 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 ...

3. 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.

4. cambridge.org cambridge.org/core/journals/canadian-journal-of-neurological-sciences/article/assessment-of-the-relationship-between-amino-acid-status-and-parkinsons-disease-a-comprehensive-review-and-metaanalysis/BAED9FA70A7AC459EE88FCE3E16D63BF

Assessment of the Relationship Between Amino Acid ... This study provides strong evidence that neurodegenerative diseases, particularly PD, are closely related to the amino acid profiles of ...

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

Amino acid management of Parkinson's disease: a case study A case study outlining a novel approach for the treatment of Parkinson's disease that allows for management of problems associated with l-dopa administration.

6. withpower.com withpower.com/trial/phase-parkinson-disease-8-2025-aa5b7

Amino Acid Supplement for Parkinson's Disease This N/A medical study run by Cristina Colon-Semenza needs participants to evaluate whether Targeted Amino Acid Supplement will have tolerable side effects ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295359/

Branched-Chain Amino Acids in Parkinson's Disease We explored the dualistic role of BCAAs as both potential neuroprotective agents and metabolic stressors, and critically examined the therapeutic prospects and ...