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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMS 90® | Active Comparator |
| |
| Placebo (Soy protein) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | 1 sachect (10 g) 2times/ day |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roongroj Bhidayasiri, MD | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University Hospital | Pathumwan | Bangkok | 10330 | Thailand |
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| Soy protein |
| Dietary Supplement |
1 sachect (10g) 2times/day |
|
| • 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D000080874 | Synucleinopathies |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D010940 | Plant Proteins |
| D014674 | Plant Proteins, Dietary |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
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