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

NCT ID: NCT01662414

Last Updated: 2013-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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HMS 90®

Group Type ACTIVE_COMPARATOR

Whey protein

Intervention Type DIETARY_SUPPLEMENT

1 sachect (10 g) 2times/ day

Placebo (Soy protein)

Group Type PLACEBO_COMPARATOR

Soy protein

Intervention Type DIETARY_SUPPLEMENT

1 sachect (10g) 2times/day

Interventions

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Whey protein

1 sachect (10 g) 2times/ day

Intervention Type DIETARY_SUPPLEMENT

Soy protein

1 sachect (10g) 2times/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roongroj Bhidayasiri, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Chulalongkorn University Hospital

Pathumwan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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53653

Identifier Type: -

Identifier Source: org_study_id