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
  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:


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 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: September 27, 2013
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 August 20, 2014