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

Tracking Information

First Received Date ^ICMJE

August 7, 2012

Last Updated Date

August 7, 2012

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

Intervention ^ICMJE

Dietary Supplement: Whey protein
1 sachect (10 g) 2times/ day
Dietary Supplement: Soy protein
1 sachect (10g) 2times/day

Study Arm (s)

Active Comparator: HMS 90®
Intervention: Dietary Supplement: Whey protein
Placebo Comparator: Placebo (Soy protein)
Intervention: Dietary Supplement: Soy protein

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with Idiopathic Parkinson's Disease
Subjects who are willing and able to participate in the trial and has provided written, informed consent.

Exclusion Criteria:

Subjects who are allergic to Whey protein (HMS 90®).
Subjects who are treated with chemotherapy .
Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease.
Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roongroj Bhidayasiri, MD

+662 256 4630

rbh1@ucla.edu

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01662414

Other Study ID Numbers ^ICMJE

53653

Has Data Monitoring Committee

Not Provided

Responsible Party

Chulalongkorn University

Study Sponsor ^ICMJE

Chulalongkorn University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Roongroj Bhidayasiri, MD

Chulalongkorn University

Information Provided By

Chulalongkorn University

Verification Date

August 2012

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

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