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

Primary Purpose

Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Whey protein
Soy protein
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chulalongkorn University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HMS 90®

Placebo (Soy protein)

Arm Description

Outcomes

Primary Outcome Measures

Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
• Parkinson's Disease quality of life questionnaire score change from baseline to week 24
Nutrition Questionnaire score change baseline to week 24

Full Information

First Posted
August 7, 2012
Last Updated
September 27, 2013
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01662414
Brief Title
Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HMS 90®
Arm Type
Active Comparator
Arm Title
Placebo (Soy protein)
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Intervention Description
1 sachect (10 g) 2times/ day
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy protein
Intervention Description
1 sachect (10g) 2times/day
Primary Outcome Measure Information:
Title
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
Time Frame
6 months
Title
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
Time Frame
6 months
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
Time Frame
6 months
Title
• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
Time Frame
6 months
Title
• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
Time Frame
6 months
Title
• Parkinson's Disease quality of life questionnaire score change from baseline to week 24
Time Frame
6 months
Title
Nutrition Questionnaire score change baseline to week 24
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roongroj Bhidayasiri, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn University Hospital
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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

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