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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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]
  • Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: April 2011
Study Completion Date: December 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662414


Locations
Thailand
Chulalongkorn University Hospital
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Roongroj Bhidayasiri, MD Chulalongkorn University
  More Information

Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01662414     History of Changes
Other Study ID Numbers: 53653
First Submitted: August 7, 2012
First Posted: August 10, 2012
Last Update Posted: September 30, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Disease
Parkinson Disease
Nervous System Diseases
Movement Disorders
Brain Diseases
Neurodegenerative Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Pathologic Processes


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