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NCT Number: NCT01662414

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

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

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chulalongkorn University Hospital

Pathumwan, Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with Idiopathic Parkinson's Disease
  • Subjects who are willing and able to participate in the trial and has provided written, informed consent.

Exclusion criteria

  • 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

Treatment and study plan

Whey Protein

Dietary Supplement

1 sachect (10 g) 2times/ day

Soy protein

Dietary Supplement

1 sachect (10g) 2times/day

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

  6. Nutrition Questionnaire score change baseline to week 24

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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