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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01662414
First received: August 7, 2012
Last updated: September 27, 2013
Last verified: September 2013

August 7, 2012
September 27, 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 ] [ Designated as safety issue: Yes ]
  • Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Parkinson's Disease quality of life questionnaire score change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nutrition Questionnaire score change baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Clinical Global impression (CGI) - Change scale score, change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Clinical Global impression (CGI) - Severity scale score change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • • Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nutrition Questionnaire score change baseline to week 24 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01662414
53653
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