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

Chulalongkorn University

Status and phase: Completed; Phase 4

Conditions: Basal Ganglia Diseases; Parkinsonian Disorders; Neurodegenerative Diseases; Movement Disorders; Central Nervous System Diseases; Parkinson Disease; Nervous System Diseases; Brain Diseases

Treatments: Dietary Supplement: Soy protein; Dietary Supplement: Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT01662414

53653

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

HMS 90®

Active Comparator group

Treatment:

Dietary Supplement: Whey protein

Placebo (Soy protein)

Placebo Comparator group

Treatment:

Dietary Supplement: Soy protein