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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01662414 |
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Date of registration:
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07/08/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
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Scientific 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 |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01662414 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Roongroj Bhidayasiri, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chulalongkorn University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects with Idiopathic Parkinson's Disease
2. Subjects who are willing and able to participate in the trial and has provided
written, informed consent.
Exclusion Criteria:
1. Subjects who are allergic to Whey protein (HMS 90®).
2. Subjects who are treated with chemotherapy .
3. Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.
4. Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Central Nervous System Diseases
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Parkinsonian Disorders
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Movement Disorders
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Nervous System Diseases
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Neurodegenerative Diseases
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Parkinson Disease
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Basal Ganglia Diseases
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Brain Diseases
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Intervention(s)
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Dietary Supplement: Whey protein
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Dietary Supplement: Soy protein
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Primary Outcome(s)
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Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
[Time Frame: 6 months]
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Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
[Time Frame: 6 months]
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Secondary Outcome(s)
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Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
[Time Frame: 6 months]
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• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
[Time Frame: 6 months]
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• Parkinson's Disease quality of life questionnaire score change from baseline to week 24
[Time Frame: 6 months]
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Nutrition Questionnaire score change baseline to week 24
[Time Frame: 6 months]
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• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
[Time Frame: 6 months]
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Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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