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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01662414

Enrollment

Registered

2012-08-10

Start date

2011-04-30

Completion date

2012-12-31

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DIETARY_SUPPLEMENTWhey protein

1 sachect (10 g) 2times/ day

DIETARY_SUPPLEMENTSoy protein

1 sachect (10g) 2times/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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

Design outcomes

Primary

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

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026