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

This study is currently recruiting participants.
Verified August 2012 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01662414
First received: August 7, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
 Dietary Supplement: Whey protein
Dietary Supplement: Soy protein
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HMS 90® Dietary Supplement: Whey protein
1 sachect (10 g) 2times/ day
Placebo Comparator: Placebo (Soy protein) Dietary Supplement: Soy protein
1 sachect (10g) 2times/day

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662414

Contacts
Contact: Roongroj Bhidayasiri, MD +662 256 4630 rbh1@ucla.edu

Locations
Thailand
Chulalongkorn University Hospital Recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Roongroj Bhidayasiri, MD     +662 256 4630     rbh1@ucla.edu    
Principal Investigator: Roongroj Bhidayasiri, MD            
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Roongroj Bhidayasiri, MD Chulalongkorn University
  More Information

No publications provided

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01662414     History of Changes
Other Study ID Numbers: 53653
Study First Received: August 7, 2012
Last Updated: August 7, 2012
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Ganglion Cysts
Movement Disorders
Nervous System Diseases
Parkinson Disease
 Parkinsonian Disorders
Neurodegenerative Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 16, 2013