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Physiological Effects of Nutritional Support in Patients With Parkinson's Disease

Tracking Information
First Received Date  ICMJE	January 23, 2015
Last Updated Date	May 15, 2015
Start Date  ICMJE	March 2014
Estimated Primary Completion Date	March 2017   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE  (submitted: May 14, 2015)	Changes in the dopamine transporter (DAT) which reflects the overall health of the dopaminergic system [ Time Frame: Baseline and 90 ± 30 days ] [ Designated as safety issue: No ] Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan) of Dopamine Uptake
Original Primary Outcome Measures  ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02445651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE	Not Provided
Original Secondary Outcome Measures  ICMJE	Not Provided
Current Other Outcome Measures  ICMJE	Not Provided
Original Other Outcome Measures  ICMJE	Not Provided
Descriptive Information
Brief Title  ICMJE	Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Official Title  ICMJE	Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Brief Summary	Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more than a million Americans. It's most prominent pathology is the degeneration of dopaminergic neurons in the brain. It is believed that oxidative stress and inflammation play an important role in the pathophysiology of Parkinson's disease as well. The object of this study is to evaluate whether nutritional supplementation with compounds that have been shown to have either anti- inflammatory, or antioxidant effects, might support brain function in patients with Parkinson's disease, particularly in regards to the dopamine system. Enrolled patients will be randomly assigned to receive oral nutritional supplementation, oral and intravenous n-acetyl cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan) single photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD. Subjects will receive a DaTSCAN and MRS initially and after completing the supplement or NAC regimen.
Detailed Description	The study consists of three arms. The nutritional supplementation will be one arm, and will include Baicalin, Curcumin, Omega 3 fatty acids, and Ganoderma, which are commonly used by PD patients. Each of these compounds is available currently as an oral dietary supplement. The purpose of this study is to explore whether these supplements provide additional support for dopamine function in the brain of patients with PD. Baicalin is one of several constituents of Scutellaria baicalensis. Scutellaria as a genus is a hardy perennial herb native to North America. It is a member of the mint family Lamiaceae, which also includes many other edible herbs. Baicalin is a dietary bioflavonoid, which has been found to support anti-inflammatory effects in the body. Turmeric is derived from the Curcuma longa plant. It is a gold-colored spice commonly used in India. Curcumin is a major component of turmeric and gives turmeric its unique yellow color. Curcumin is used as a spice and a food coloring agent. It has powerful antioxidant and anti-inflammatory properties. Omega-3 Fatty acids are commonly found in foods and are believed to support anti-inflammatory effects. Ganoderma is a mushroom that has been widely used as dietary supplement and is believed to support immune function. A second arm of this study will receive intravenous and oral NAC, which is a strong antioxidant that increases brain glutathione, which may be beneficial in PD. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC, such as its potential to counteract intracellular damage that leads to dopaminergic neuron death. It also has the potential to reduce markers of oxidative damage, protect against dopamine cell death from MPTP toxicity, and to increase glutathione in blood, which might be useful in preventing oxidative damage in PD patients. The third arm will be a waitlist control receiving standard PD care. It should be noted that all three arms will receive standard PD care which will be augmented with the oral supplements or NAC.
Study Type  ICMJE	Interventional
Study Phase	Not Provided
Study Design  ICMJE	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition  ICMJE	Parkinson Disease Idiopathic Parkinson Disease
Intervention  ICMJE	Dietary Supplement: Baicalin, Curcumin, Ganoderma, Omega 3 Dietary Supplement: Intravenous and Oral n—acetyl cysteine
Study Arm (s)	Supplement Cohort Baicalin - 400mg (Narula Research) 2 x per day Curcumin Phytosome - 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Intervention: Dietary Supplement: Baicalin, Curcumin, Ganoderma, Omega 3 N-acetyl Cysteine Cohort Intravenous N-acetyl Cysteine - 50mg in 200ml of D5W over one hour 1 x per week Oral N-acetyl Cysteine - 1 600mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered) Intervention: Dietary Supplement: Intravenous and Oral n—acetyl cysteine No Intervention: Control Cohort Standard of Care Treatment

Study 1: Ketogenic Diets for Symptoms of Parkinson's Disease
  Recruitment: Recruiting
  Study Results: No Results Available
  Conditions: Parkinson's Disease
  Interventions: Dietary Supplement: Ketone ester drink|Dietary Supplement: Placebo (carbohydrate containing) drink
  Sponsor/Collaborators:  University of Oxford
  Gender: Both
  Age Groups:  Adult|Senior
  Phases:                   
  Enrollment:  20
  Funded Bys:  Other
  Study Types:  Interventional
  Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject, Outcomes Assessor)
  Other IDs: 10/H0606/74
  First Received:  May 18, 2011
  Start Date: May 2011
  Completion Date:  null
  Last Updated: June 1, 2011
  Last Verified: May 2011
  Acronym:  null
  Results First Received: No Study Results Posted
  Primary Completion Date:  May 2012
  Outcome Measures: Unified Parkinson's Disease rating Scale, part III (motor)|Timed motor tasks as per CAPSIT|Computerised reaction time and cogntive tests|Unified Parkinson's disease rating scale, parts I, II, IV|Dopaminergic medication requirements (expressed as levodopa dose equivalent, mg/day)
  URL:  http://ClinicalTrials.gov/show/NCT01364545

Study 2: Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease
  Recruitment: Not yet recruiting
  Study Results: No Results Available
  Conditions: Parkinson Disease
  Interventions: Dietary Supplement: different diets
  Sponsor/Collaborators:  Sheba Medical Center|Tel Aviv University
  Gender: Both
  Age Groups: Adult|Senior
  Phases:                   
  Enrollment: 20
  Funded Bys: Other
  Study Types: Interventional
  Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Crossover Assignment|Primary Purpose: Treatment|Masking: Single Blind (Investigator)
  Other IDs: 1310-14-SMC
  First Received: October 22, 2014
  Start Date:  October 2014
  Completion Date:  December 2017
  Last Updated: October 23, 2014
  Last Verified: October 2014
  Acronym: null
  Results First Received: No Study Results Posted
  Primary Completion Date:  October 2017
  Outcome Measures: quality of life|dyskinesias|fluctuations|motor function
  URL:  http://ClinicalTrials.gov/show/NCT02274324

Study 3: Evaluation of a Diet in Patients With Senile Dementia
  Recruitment:  Recruiting
  Study Results: No Results Available
  Conditions: Alzheimer's Disease|Parkinson's Disease|Senile Dementia
  Interventions: Dietary Supplement: Supressi. T-Diet plus Range|Dietary Supplement: High Protein. T-Diet plus Range
  Sponsor/Collaborators:  Vegenat, S.A.
  Gender:  Both
  Age Groups:  Senior
  Phases:                   
  Enrollment: 184
  Funded Bys: Industry
  Study Types: Interventional
  Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Supportive Care|Masking: Double Blind (Subject,  Caregiver)
  Other IDs: VEGENAT-SUPR|SUPRESSI2010-PROYECTO CDTI
  First Received:  August 30, 2010
  Start Date:  October 2010
  Completion Date: December 2012
  Last Updated: June 21, 2012
  Last Verified: February 2011
  Acronym: SUPRESSI
  Results First Received:  No Study Results Posted
  Primary Completion Date:  September 2012
  Outcome Measures: Nutritional and cognitive status in elderly people|Biochemical parameters measure
  URL: http://ClinicalTrials.gov/show/NCT01192529

Study 5: Parkinson's Genes and Environment Study
  Recruitment: Completed
  Study Results: No Results Available
  Conditions: Parkinson's Disease
  Interventions:            
  Sponsor/Collaborators: National Institute of Environmental Health Sciences (NIEHS)|National Institutes of Health Clinical Center (CC)
  Gender:  Both
  Age Groups: Adult|Senior
  Phases:                   
  Enrollment:  3100
  Funded Bys: NIH
  Study Types: Observational
  Study Designs: Time Perspective: Prospective
  Other IDs: 999906093|06-E-N093
  First Received: August 22, 2006
  Start Date: February 2006
  Completion Date: null
  Last Updated:  May 22, 2015
  Last Verified:  May 2015
  Acronym:  null
  Results First Received:  No Study Results Posted
  Primary Completion Date: null
  Outcome Measures:         
  URL:  http://ClinicalTrials.gov/show/NCT00367900

Study 5: Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease
  Recruitment:  Suspended
  Study Results:  No Results Available
  Conditions:  Parkinson's Disease
  Interventions:  Dietary Supplement: Vitamin D3|Dietary Supplement: Vitamin D3 - high dose|Dietary Supplement: Placebo
  Sponsor/Collaborators:  Emory University
  Gender: Both
  Age Groups: Adult|Senior
  Phases: Phase 4
  Enrollment: 31
  Funded Bys: Other
  Study Types: Interventional
  Study Designs: Allocation: Randomized|Endpoint Classification: Efficacy Study|Intervention Model: Parallel Assignment|Primary Purpose: Treatment|Masking: Double Blind (Subject,  Caregiver,  Investigator,  Outcomes Assessor)
  Other IDs:  IRB00004539|VIDIP PILOT
  First Received: December 7, 2007
  Start Date:               June 2007
  Completion Date:          December 2015
  Last Updated:             December 16, 2014
  Last Verified:            December 2014
  Acronym:  VIDIP PILOT
  Results First Received:  No Study Results Posted
  Primary Completion Date: January 2011
  Outcome Measures:  Change from Baseline Visit to 3 month (Treatment Visit #1)in the TUG , timed walking task (8-meters) and UPDRS III subscore|1. Change from Baseline Visit to 3 month (Visit #1) and 6 month (Visit #2) in the UPDRS II, BAI-II and BDI-II score.
  URL:  http://ClinicalTrials.gov/show/NCT00571285