Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease. The principal objective is to evaluate the changes in biomarkers of oxidative stress and,plasma amino acids, as well as improvement of clinical symptoms and brain function

Official Title
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Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain Function

Conditions
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Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

Intervention / Treatment
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* Dietary Supplement: Whey protein
* Dietary Supplement: Soy protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Idiopathic Parkinson's Disease Subjects who are willing and able to participate in the trial and has provided written, informed consent. Exclusion Criteria: Subjects who are allergic to Whey protein (HMS 90®). Subjects who are treated with chemotherapy . Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease. Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HMS 90®<br> | Dietary Supplement: Whey protein<br>* 1 sachect (10 g) 2times/ day<br>|
| Placebo Comparator: Placebo (Soy protein)<br> | Dietary Supplement: Soy protein<br>* 1 sachect (10g) 2times/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status |  | 6 months | 
| Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24 |  | 6 months | 
| Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24 |  | 6 months | 
| • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24 |  | 6 months | 
| • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24 |  | 6 months | 
| • Parkinson's Disease quality of life questionnaire score change from baseline to week 24 |  | 6 months | 
| Nutrition Questionnaire score change baseline to week 24 |  | 6 months |