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

Chulalongkorn University38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status

Time frame: 6 months

Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan

Time frame: 6 months

Secondary Outcomes

Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24

Time frame: 6 months

Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24

Time frame: 6 months

• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24

Time frame: 6 months

• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24

Time frame: 6 months

• Parkinson's Disease quality of life questionnaire score change from baseline to week 24

Time frame: 6 months

Nutrition Questionnaire score change baseline to week 24

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes