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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2022-08-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease Idiopathic Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To evaluate whether IV/oral N acetyl cysteine, compared to standard of care ,no intervention, (or the discontinued oral supplementation arm) helps support dopamine function in the brains of patients with Parkinson's disease measured using Iofluvane (DATScan); clinical symptoms will be measured.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an Open Label study. Randomization will occur via a 2:1 ratio of the NAC group and the control and oral supplement groups using the method of random permuted blocks with random block sizes without stratification. 28 subjects in the NAC arm, 14 subjects have been enrolled in the standard of care arm. 9 subjects who were enrolled in a discontinued oral supplement arm of the study were not included in final study analysis.

Study Groups

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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)

Group Type EXPERIMENTAL

Intravenous and Oral n-acetyl cysteine

Intervention Type DIETARY_SUPPLEMENT

Control Cohort

Standard of Care Treatment

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

Standard of Care

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.

Group Type ACTIVE_COMPARATOR

Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Intravenous and Oral n-acetyl cysteine

Intervention Type DIETARY_SUPPLEMENT

Control group

Standard of Care

Intervention Type OTHER

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No