Trial Outcomes & Findings for Physiological Effects of Nutritional Support in Patients With Parkinson's Disease (NCT NCT02445651)
NCT ID: NCT02445651
Last Updated: 2025-12-15
Results Overview
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
COMPLETED
NA
51 participants
Baseline and 90 ± 30 days
2025-12-15
Participant Flow
Subjects will be recruited from patients presenting to either the Marcus Integrative Health at the Myrna Brind Center - Philadelphia and Villanova or the Thomas Jefferson University Department of Neurology Movement Disorders Clinic. Neurology Department physicians can refer directly to the study. Participants were recruited from the Thomas Jefferson University, All enrolled participants received their baseline and 3-month follow-up visit between June 26, 2014, and December 8, 2016.
Participants must meet eligibility criteria and be available to participate in the research study. Potential participants who do not meet inclusion and exclusion criteria may be enrolled in the study. Eligible enrolled participants received a baseline neurological evaluation of their symptoms using the UPDRS and an initial SPECT DATscan before proceeding to randomization.
Participant milestones
| Measure |
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)
Intravenous and Oral n-acetyl cysteine
|
Control Cohort
Standard of Care Treatment
|
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 Fatty Acids and Curcumin
Self administration of 4 oral supplements Baicalin, Ganoderma, Omega 3 and Curcumin
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
14
|
9
|
|
Overall Study
COMPLETED
|
28
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Oral and IV N Acetyl Cysteine Cohort
n=28 Participants
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)
Intravenous and Oral n-acetyl cysteine
|
Control Cohort
n=14 Participants
Standard of Care Treatment
|
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin
n=9 Participants
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
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=6009 Participants
|
9 Participants
n=42 Participants
|
6 Participants
n=77 Participants
|
31 Participants
n=387 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=6009 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=77 Participants
|
20 Participants
n=387 Participants
|
|
Age, Continuous
|
62.4 Years
n=6009 Participants
|
61.3 Years
n=42 Participants
|
60.6 Years
n=77 Participants
|
62 Years
n=387 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=6009 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=77 Participants
|
28 Participants
n=387 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=6009 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=77 Participants
|
23 Participants
n=387 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=6009 Participants
|
14 Participants
n=42 Participants
|
9 Participants
n=77 Participants
|
51 Participants
n=387 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=387 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=6009 Participants
|
14 participants
n=42 Participants
|
9 participants
n=77 Participants
|
51 participants
n=387 Participants
|
PRIMARY outcome
Timeframe: Baseline and 90 ± 30 daysPopulation: 51 participants were enrolled for full course of the study. Using a 2:1 randomization technique, 28 subjects, 14 men and 14 women, were randomized to the NAC arm; 14 subjects, 7 men and 7 women, were assigned to the waitlist control arm. 9 participants in the Oral Supplement arm. The Oral supplement arm of the study was discontinued to focus on a comparison of NAC and controls. Swallowing multiple oral supplements was difficult for persons with Parkinson's disease.
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
Outcome measures
| Measure |
Oral and IV N acetyl Cysteine Cohort
n=28 Participants
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)
Intravenous and Oral n-acetyl cysteine
|
Control Cohort
n=14 Participants
Standard of Care Treatment
|
Oral Supplements Cohort: Baicalin, Ganoderma, Omega 3 and Curcumin
n=9 Participants
Oral supplements Baicalin, Curcumin, Omega 3 fatty acids, and Ganoderma 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
|
|---|---|---|---|
|
Distribution Volume Ratio
Degree of DAT binding Caudate DAT-binding pre
|
2.65 Distribution volume ratios
Interval 2.5 to 2.8
|
2.70 Distribution volume ratios
Interval 2.49 to 2.92
|
2.96 Distribution volume ratios
Interval 2.04 to 3.69
|
|
Distribution Volume Ratio
Degree of DAT binding Caudate DAT-binding post
|
2.74 Distribution volume ratios
Interval 2.59 to 2.89
|
2.65 Distribution volume ratios
Interval 2.44 to 2.86
|
2.93 Distribution volume ratios
Interval 2.0 to 3.53
|
|
Distribution Volume Ratio
Degree of DAT binding Putamen DAT-binding pre
|
1.68 Distribution volume ratios
Interval 1.54 to 1.83
|
1.84 Distribution volume ratios
Interval 1.63 to 2.05
|
1.83 Distribution volume ratios
Interval 1.4 to 2.5
|
|
Distribution Volume Ratio
Degree of DAT binding Putamen DAT-binding post
|
1.82 Distribution volume ratios
Interval 1.67 to 1.97
|
1.73 Distribution volume ratios
Interval 1.52 to 1.94
|
1.80 Distribution volume ratios
Interval 1.48 to 2.33
|
|
Distribution Volume Ratio
Degree of DAT binding Caudate pre-post change
|
0.092 Distribution volume ratios
Interval 0.013 to 0.17
|
-0.059 Distribution volume ratios
Interval -0.171 to 0.052
|
-0.031 Distribution volume ratios
Interval -0.381 to 0.232
|
|
Distribution Volume Ratio
Degree of DAT binding Putamen pre-post change
|
0.135 Distribution volume ratios
Interval 0.056 to 0.214
|
-0.110 Distribution volume ratios
Interval -0.222 to 0.001
|
-0.032 Distribution volume ratios
Interval -0.463 to 0.19
|
|
Distribution Volume Ratio
Degree of SERT binding Midbrain SERT binding pre measures
|
1.48 Distribution volume ratios
Interval 1.41 to 1.55
|
1.59 Distribution volume ratios
Interval 1.49 to 1.69
|
1.55 Distribution volume ratios
Interval 1.32 to 1.81
|
|
Distribution Volume Ratio
Degree of SERT binding Midbrain SERT binding pre measures Midbrain SERT binding post measures
|
1.62 Distribution volume ratios
Interval 1.55 to 1.69
|
1.48 Distribution volume ratios
Interval 1.38 to 1.57
|
1.54 Distribution volume ratios
Interval 1.43 to 1.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to evaluate inclusion criteriaPopulation: Demographic characteristics of the enrolled study population will be analyzed based on the duration of Parkinson's Disease in years. This data will be used in descriptive analysis of the enrolled participant cohorts. The Oral Supplement data was not collected or analyzed; the protocol was amended to close this arm of the study.
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.
Outcome measures
| Measure |
Oral and IV N acetyl Cysteine Cohort
n=28 Participants
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)
Intravenous and Oral n-acetyl cysteine
|
Control Cohort
n=14 Participants
Standard of Care Treatment
|
Oral Supplements Cohort: Baicalin, Ganoderma, Omega 3 and Curcumin
Oral supplements Baicalin, Curcumin, Omega 3 fatty acids, and Ganoderma 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
|
|---|---|---|---|
|
Years: Number of Years With Parkinson's
|
4.3 Years
Standard Deviation 3.9
|
4.1 Years
Standard Deviation 3.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to evaluate inclusion criteriaPopulation: Analysis was conducted only in the Parkinson's patients in the Oral and IV NAC Cohort and the Standard of Care Control Group
"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.
Outcome measures
| Measure |
Oral and IV N acetyl Cysteine Cohort
n=28 Participants
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)
Intravenous and Oral n-acetyl cysteine
|
Control Cohort
n=14 Participants
Standard of Care Treatment
|
Oral Supplements Cohort: Baicalin, Ganoderma, Omega 3 and Curcumin
Oral supplements Baicalin, Curcumin, Omega 3 fatty acids, and Ganoderma 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
|
|---|---|---|---|
|
Severity of Parkinson's Disease Symptom Progression Based Upon the Hoehn and Yahr Scale
|
1.8 Group comparison between Mean and SD in
Standard Deviation 0.7
|
1.8 Group comparison between Mean and SD in
Standard Deviation 0.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: 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 cohorts. Parkinson's Patients enrolled in the NAC and standard of care cohorts were included in the analysis. Medications were reviewed to determine whether participant was taking levodopa/carbidopa at the time of enrollment.
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.
Outcome measures
| Measure |
Oral and IV N acetyl Cysteine Cohort
n=28 Participants
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)
Intravenous and Oral n-acetyl cysteine
|
Control Cohort
n=14 Participants
Standard of Care Treatment
|
Oral Supplements Cohort: Baicalin, Ganoderma, Omega 3 and Curcumin
Oral supplements Baicalin, Curcumin, Omega 3 fatty acids, and Ganoderma 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
|
|---|---|---|---|
|
Whether Each Participant is Prescribed and Taking Carbidopa/Levodopa for Parkinson's Disease
No
|
9 participants
|
7 participants
|
—
|
|
Whether Each Participant is Prescribed and Taking Carbidopa/Levodopa for Parkinson's Disease
Yes
|
19 participants
|
7 participants
|
—
|
Adverse Events
Oral and IV N acetyl Cysteine Cohort
Control Cohort
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place