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

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

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

Study Overview

• Status: Completed
• Conditions: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases
• Intervention / Treatment: Dietary supplement: Whey protein; Dietary supplement: Soy protein

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathumwan, Bangkok, Thailand, 10330
      • Chulalongkorn University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status	6 months
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24	6 months
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24	6 months
• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24	6 months
• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24	6 months
• Parkinson's Disease quality of life questionnaire score change from baseline to week 24	6 months
Nutrition Questionnaire score change baseline to week 24	6 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Roongroj Bhidayasiri, MD, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: August 7, 2012
• First Posted (Estimate): August 10, 2012

Study Record Updates

• Last Update Posted (Estimate): September 30, 2013
• Last Update Submitted That Met QC Criteria: September 27, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Synucleinopathies; Disease; Parkinson Disease; Nervous System Diseases; Brain Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Central Nervous System Diseases; Basal Ganglia Diseases
• Other Study ID Numbers: 53653