Parkinson DiseasePhase 4NCT01662414
Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
A Phase 4 study testing Whey protein and Soy protein in people with Parkinson Disease and Parkinsonian Disorders, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases
- What is being tested?
- Whey protein and Soy protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with Idiopathic Parkinson's Disease
- Subjects who are willing and able to participate in the trial and has provided written, informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Being tested
- Whey protein, Soy protein
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
1 sachect (10 g) 2times/ day
Soy proteinDietary supplement
1 sachect (10g) 2times/day
| Study group | Role | What they receive |
|---|---|---|
| HMS 90® | Active comparator | Not described Receives: Dietary Supplement: Whey protein |
| Placebo (Soy protein) | Placebo comparator | Not described Receives: Dietary Supplement: Soy protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
Measured: 6 months
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
Measured: 6 months
Secondary outcomes (6)
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
Measured: 6 months
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
Measured: 6 months
• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
Measured: 6 months
• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
Measured: 6 months
• Parkinson's Disease quality of life questionnaire score change from baseline to week 24
Measured: 6 months
Nutrition Questionnaire score change baseline to week 24
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roongroj Bhidayasiri, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662414
- Sponsor's protocol ID
- 53653
- Status last verified
- Sep 2013
- First submitted
- 7 Aug 2012
- Last updated
- 30 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01662414
- Acronym / sponsor ID
- 53653
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMS 90® | Active comparator | Dietary Supplement: Whey protein |
| Placebo (Soy protein) | Placebo comparator | Dietary Supplement: Soy protein |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with Idiopathic Parkinson's Disease
- Subjects who are willing and able to participate in the trial and has provided written, informed consent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein1 sachect (10 g) 2times/ day | Dietary supplement | HMS 90® |
| Soy protein1 sachect (10g) 2times/day | Dietary supplement | Placebo (Soy protein) |
Primary outcome
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status
Time frame: 6 months
Concentrationsrofiles of plasma amino acids and their derivatives Brain function by PET-Scan
Time frame: 6 months
6 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 24
Time frame: 6 months
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change baseline to week 24
Time frame: 6 months
• Clinical Global impression (CGI) - Change scale score, change from baseline to week 24
Time frame: 6 months
• Clinical Global impression (CGI) - Severity scale score change from baseline to week 24
Time frame: 6 months
• Parkinson's Disease quality of life questionnaire score change from baseline to week 24
Time frame: 6 months
Nutrition Questionnaire score change baseline to week 24
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roongroj Bhidayasiri, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Whey protein and Soy protein in people with Parkinson Disease and Parkinsonian Disorders, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of oxidative stress, i.e., plasma glutathione (reduced and oxidized forms), urinary 8-hydroxydeoxyguanosine, and urinary total antioxidant status (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.