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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662414
First Posted: August 10, 2012
Last Update Posted: September 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chulalongkorn University
August 7, 2012
August 10, 2012
September 30, 2013
April 2011
December 2012   (Final data collection date for primary outcome measure)
  • Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status [ Time Frame: 6 months ]
  • Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01662414 on ClinicalTrials.gov Archive Site
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24 [ Time Frame: 6 months ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24 [ Time Frame: 6 months ]
  • • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24 [ Time Frame: 6 months ]
  • • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24 [ Time Frame: 6 months ]
  • • Parkinson's Disease quality of life questionnaire score change from baseline to week 24 [ Time Frame: 6 months ]
  • Nutrition Questionnaire score change baseline to week 24 [ Time Frame: 6 months ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24 [ Time Frame: 6 months ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24 [ Time Frame: 6 months ]
  • • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24 [ Time Frame: 6 months ]
  • • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24 [ Time Frame: 6 months ]
  • • Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 24 [ Time Frame: 6 months ]
  • Nutrition Questionnaire score change baseline to week 24 [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
  • Parkinson Disease
  • Parkinsonian Disorders
  • Basal Ganglia Diseases
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Movement Disorders
  • Neurodegenerative Diseases
  • Dietary Supplement: Whey protein
    1 sachect (10 g) 2times/ day
  • Dietary Supplement: Soy protein
    1 sachect (10g) 2times/day
  • Active Comparator: HMS 90®
    Intervention: Dietary Supplement: Whey protein
  • Placebo Comparator: Placebo (Soy protein)
    Intervention: Dietary Supplement: Soy protein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01662414
53653
Not Provided
Not Provided
Not Provided
Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Roongroj Bhidayasiri, MD Chulalongkorn University
Chulalongkorn University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP