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

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 oral and IV N acetyl cysteine 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 and intravenous (IV) n-acetyl cysteine (NAC), a control group of standard PD care, or an oral supplement group who will receive Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin. (Please note, the Oral Supplements arm, was amended and not included in analysis.

This study utilized 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 received a DaTSCAN and MRS initially and after completing oral and IV NAC regimen. Subjects in the control group received pre and post DaTScans and MRS and similar evaluations to the Dietary Supplement oral and IV NAC group.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Idiopathic Parkinson Disease
• Intervention / Treatment: Dietary supplement: Intravenous and Oral n-acetyl cysteine; Other: Control group; Dietary supplement: Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin

Detailed Description

The first arm of this study received 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. NAC 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 second arm was a waitlist control group who received no intervention. The control group continued to receive clinical standard of care treatment for PD care provided by their neurologist.

A third arm of the study was an oral supplement group who received Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin.This oral supplement group continued to receive clinical standard of care treatment for PD provided by their neurologist.

The protocol was amended to include only the NAC arm and the standard of care waitlist control groups.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical Diagnosis of Parkinson's disease
• Subject is between 30 - 80 years of age
• Subject has a Hoehn and Yahr score of I - II inclusive
• Subject is on stable or on antiparkinsonian medication for at least a month
• Women of Childbearing potential will confirm a negative pregnancy test

Exclusion Criteria:

• Subject is allergic to iodine, cobalt, or any of the supplements that will be given in the study
• Subject has had previous brain surgery
• Subject has a score of 25 or less on Mini-Mental Status examination
• Subject is wheelchair-bound or bed-ridden; non ambulatory
• Subject has intracranial abnormalities that may complicate interpretation of the brain scans(e.g., stroke, tumor, vascular abnormality affecting the target area)
• Subject has a history of head trauma with loss of consciousness greater than 48 hours
• Subject has any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of parkinsonian syndrome symptoms, or with any of the study assessments including the SPECT imaging.
• Subject has evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study
• Subject has a current alcohol or drug abuse
• Subject is pregnant or lactating
• Subject is enrolled in active clinical (drug or device) trial within the prior 30 days
• Subject is pending surgery during the course of the study
• History of very low blood pressure
• History of thrombocytopenia or clotting disorders
• Cancer patients receiving active chemotherapy
• History of active gallstone problems or a bile duct obstruction
• History of uncontrolled diabetes, asthma, gastroesophageal reflex disease, or thyroid
• History of severe kidney disease (if the patient reports this problem, a serum creatinine will be checked to assess GFR; if it is less than 30, the patient will be excluded)
• History of Leber's disease, a hereditary eye disease
• History of uncontrolled hypercalcemia
• History of active sarcoidosis, histoplasmosis, or lymphoma
• Patients taking medication that might interact with the supplements involved in this study will be evaluated on a case-by-case basis by PI study physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral and IV N acetyl Cysteine Cohort; Administration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of D5W, frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 600 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)	Dietary supplement: Intravenous and Oral n-acetyl cysteine
Active Comparator: Control Cohort; Standard of Care Treatment	Other: Control group; Standard of Care
Active Comparator: Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin; Baicalin 400mg (Narula Reasearch) 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 Frequency: over one hour 1 x per week for 90 days ± 30 days The protocol was amended; this cohort was not included in analysis that was reported in results.	Dietary supplement: Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin; Baicalin 400mg (Narula Reasearch) 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 Frequency: over one hour 1 x per week for 90 days ± 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution Volume Ratio	Distribution Volume Ratio reflects Iofluvane absorption by the dopamine transporters (Dopamine Uptake) that reflects binding in the dopamine transporter (DAT) overall. Striatal Binding Ratio in the regions of interest (ROI), caudate, putamen, and midbrain Serotonin Transporter (SERT) binding and Dopamine Transporter (5-HTT) Binding was measured during Single Photon Emission Computed Tomography (SPECT) Brain Imaging with DATScan (Iofluvane). Regions of interest in the caudate, putamen and in midbrain SERT binding are affected in Parkinson's Disease. Less dopamine transporter binding (lower number) indicates less activated dopamine transporters (worse); more binding (higher number) indicates more binding (better), thus, measuring the overall health of the dopaminergic system in the brain. Analysis was completed only for the Oral and IV N acetyl Cysteine Cohort and Control Cohort; the Oral Supplements arm of the study was discontinued and not included in analysis	Baseline and 90 ± 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Years: Number of Years With Parkinson's	Eligibility requires a diagnosis of Parkinson's disease. Duration of Parkinson's Disease in years will be calculate by participant self-report and review of source documentation, each year since onset of Parkinson's Disease represents one unit. A higher number in years indicates a longer duration since the onset of Parkinson's Disease.	Baseline to evaluate inclusion criteria
Severity of Parkinson's Disease Symptom Progression Based Upon the Hoehn and Yahr Scale	"The Hoehn and Yahr scale is used to describe the symptom progression of Parkinson disease. The scale originally was described in 1967 and included stages 1 through 5. It has since been modified with the addition of stages 1.5 and 2.5 to account for the intermediate course of Parkinson disease." Grade 0: No signs of disease. Grade 1: Mild symptoms; only unilateral involvement. Grade 1.5: Unilateral and axial involvement. "On this scale, stages 1 and 2 represent early-stage, 2 and 3 mid-stage, and 4 and 5 advanced-stage Parkinson's Disease." A higher score on the Hoehn & Yahr Scale is an indication of more advanced Parkinson's Disease; a higher score is an indication of the severity of disease (higher is worse). The Oral supplement arm of the study was closed.	Baseline to evaluate inclusion criteria
Whether Each Participant is Prescribed and Taking Carbidopa/Levodopa for Parkinson's Disease	Self report of medications including Carbidopa/Levodopa to determine whether each study participant is currently prescribed and taking Carbidopa/Levodopa for Parkinson's Disease? A score of 1 = Yes and 2 = no Is each study participant currently prescribed and taking Carbidopa/Levodopa for Parkinson's Disease? The response to this question is binary: Yes or No. Characteristics of the enrolled study population will be analyzed based on whether each participant is prescribed and taking Carbidopa/Levodopa for PD. This data will be used in descriptive analysis of the enrolled participant NAC and Standard of Care Control Cohorts.	Baseline

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Daniel A Monti, MD,MBA, Thomas Jefferson University

Publications and helpful links

General Publications

• Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
• Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Bazzan AJ, Zhong L, Bowens BK, Chervoneva I, Intenzo C, Newberg AB. N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease. Clin Pharmacol Ther. 2019 Oct;106(4):884-890. doi: 10.1002/cpt.1548. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimated): May 15, 2015

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Movement Disorders; Central Nervous System Diseases; Parkinson's disease; Neurodegenerative Diseases; Integrative Medicine; Brain Diseases; Complementary Medicine; N-acetyl cysteine; Alternative Medicine; Idiopathic Parkinson's disease; Single Photon Emission Computed Tomography (SPECT); Oral supplements
• Additional Relevant MeSH Terms: Synucleinopathies; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Parkinson Disease; Brain Diseases; Nervous System Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Fatty Acids; Lipids; Hydrocarbons, Acyclic; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amino Acids; Diarylheptanoids; Heptanes; Alkanes; Catechols; Phenols; Benzene Derivatives; Cysteine; Amino Acids, Sulfur; Fatty Acids, Unsaturated; Oils; Dietary Fats; Fats; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Fish Oils; Curcumin; Acetylcysteine; Control Groups; Docosahexaenoic Acids
• Other Study ID Numbers: 14D.141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.
• IPD Sharing Time Frame: Study scan report will be offer to the subject after subject completes study
• IPD Sharing Access Criteria: Authorized research personnel
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No