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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662414
• Other study ID #: 53653
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2012
• Last updated: September 27, 2013
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Thailand	Chulalongkorn University Hospital	Pathumwan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status		6 months	Yes
Primary	Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan		6 months	Yes
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24		6 months	No
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24		6 months	No
Secondary	• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24		6 months	No
Secondary	• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24		6 months	No
Secondary	• Parkinson's Disease quality of life questionnaire score change from baseline to week 24		6 months	No
Secondary	Nutrition Questionnaire score change baseline to week 24		6 months	No