Completed

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

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What is being tested

Whey protein

+ Soy protein

Dietary Supplement
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 30 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorChulalongkorn University
Last updated: September 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

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

NCT01662414
Principal SponsorChulalongkorn University
Last updated: September 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

2 inclusion criteria required to participate
Subjects who are willing and able to participate in the trial and has provided written, informed consent
Subjects with Idiopathic Parkinson's Disease
4 exclusion criteria prevent from participating
Subjects who are allergic to Whey protein (HMS 90)
Subjects who are treated with chemotherapy
Subjects with any history of neurodegenerative diseases, e.g., Alzheimer's disease
Subjects with history of diabetes. 4.5. Subjects with abnormal liver function test

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Chulalongkorn University Hospital

Pathumwan, ThailandOpen Chulalongkorn University Hospital in Google Maps
CompletedOne Study Center