Ischemic Stroke

Hanyang University

Stroke in Korean Young Adults Study

Information will be obtained from participant's last practitioner or care-giver.

Minimum necessary time interval between original event and recurrent stoke is 21 days. If a stroke occured within 21 days, it has to be located in the different vascular territory as the original event.

Subsequent fatal or nonfatal myocardial infarction

Two or more unprovoked epileptic seizures occuring at ≥1 week after the ischemic stroke event.

Young Seo Kim

Professor

Hallym University Medical Center

Seoul National University Hospital

Seoul National University Bundang Hospital

Severance Hospital

Seoul National University Boramae Hospital

Kyung Hee University Hospital

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Cerebrovascular Research Club

Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator

Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).

Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Sugar Pill

Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Protandim Dietary Supplement

Total

Sex: Female, Male

Region of Enrollment

Weight

Fasting Blood Glucose

5-km running performance time was measured twice at the beginning of the study, and then once post-supplementation. The best 5 km time from both initial sessions was counted as the baseline 5-km time. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559

Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator

Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).

5-km Running Time

Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559

Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).

Lipid Peroxides (TBARS)

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.

Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).

Glutathione Peroxidase (GPX)

This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.
Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).
Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).
Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).
Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable).

Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Placebo Group

Protandim Group

Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.

Total Antioxidant Capacity (TAC)

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.

Whole Blood Glutathione Content (GSH)

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.

Superoxide Dismutase (SOD)

Overall Study

Dr. Gerald S. Zavorsky

Oxidative Stress

This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given 675 mg per day (1 pill per day) of Protandim for 90 days. Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given 675 mg per day (1 pill per day) of corn starch for 90 days. Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.

Genova Diagnostics: The company that will analyze blood markers of oxidative stress

Crawford Gym, Room 17a, University of Louisville

The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

The Effect of 90 Days of Protandim Supplementation on Markers of Oxidative Stress, Athletic Performance, and Recovery

The de-identified data is in SPSS format placed as a supplement in the published PLOS ONE article: http://dx.doi.org/10.1371/journal.pone.0160559

Gerald S Zavorsky, PhD

Associate Professor

University of Louisville

Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent

Multiple System Atrophy

EGCG as putative neuroprotective agent

Placebo

Fox trial finder of the Michael J Fox foundation

Neurology Department, Ludwig-Maximilians University

Department of Neurology, Klinikum rechts der Isar, Technische Universität München

Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus für Bewegungsstörungen

Charité - Universitätsmedizin Berlin

Technische Universität Dresden

Heinrich-Heine-Universität, Neurologische Klinik

Paracelsus-Elena-Klinik Kassel

Universität Leipzig

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Philipps Universität Marburg

Eberhard Karls Universität Tübingen

Universitätsklinikum Ulm

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Double-blind, Randomised, Placebo-controlled Parallel Group Study to Investigate the Effect of EGCG Supplementation on Disease Progression of Patients With Multiple System Atrophy (MSA)

To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in UMSARS total score

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in clinical global impression

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral atrophy (3D MP-RAGE MRI volumetry, 3D FLAIR)

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in global and regional cerebral iron deposition in pons and striatum (T2* MRI)

Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time)

To assess any effect of EGCG vs. Placebo on the evolution of the above mentioned parameters during the wash-out phase (from V6 to V7) to explore possible symptomatic effects.

To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 in Albumine, total protein, ferritin, iron, transferrin

Dr. Johannes Levin

Sponsor delegated person

German Center for Neurodegenerative Diseases (DZNE)

Deutsche Parkinson Vereinigung

German Foundation for Neurology

ParkinsonFonds Deutschland gGmbH

Each patient will take pills twice per day containing 100-200 mg of caffeine (as synthetic caffeine alkaloid). Patients will be instructed to take whatever caffeine-containing beverages they are accustomed to taking, without changing their habitual schedule (note that all will be taking <200 mg per day). Caffeine intake will be assessed at each visit. Patients will continue their usual PD medications, without change in dose or timing for the entire duration of the study. Medication will be provided in pre-packaged dosettes.

Parkinson's Disease

The following intervention will be provided for six consecutive weeks:
Week 1 (100 mg BID), Week 2 (200 mg BID), Week 3 (300 mg BID), Week 4 (400 mg BID), Week 5 and 6(500 mg BID). At the conclusion of the study, patients will decrease their dose by 100 mg BID every other day, until caffeine is stopped. This gradual reduction will be to prevent withdrawal symptoms. If a patient experiences a dose-limiting event, they will be terminated from the study, and will withdraw from the medication in the same manner. If dose-limiting events occur between visits, patients will be encouraged to decrease the caffeine dose back to the previously-tolerated dose until in-person assessment can be performed.

Caffeine alkaloid

Ongoing study investigating caffeine for excessive daytime somnolence in Parkinson's Disease

Montreal General Hospital

Caffeine for Motor Manifestations of Parkinson's Disease

Caffeine for Motor Manifestations of Parkinson's Disease: An Open-Label Dose-Response Study.

Patients will be given a structured questionnaire targeting common side effects of caffeine, as well as a series of open-ended questions for other side effects. Vital signs will be measured. Questionnaire symptoms will be selected, where available, from the common terminology criteria for adverse events, version 3.0, developed by the National Cancer Institute. A severity of 2 or greater on the 5-point scale will delineate a dose-limiting effect. Evaluations will occur in person after 2 weeks, 4 weeks, 6 weeks (at study termination) and via telephone follow-up at the end of weeks 1,3 and 5.

Will systematically track changes in ESS.

Systematically performing part II of the UPDRS, motor examination.

This is a measure of gait and transfer speed.

This self-completion questionnaire addresses aspects of functioning and well-being in those affected by Parkinson's Disease (PD). Considered to be the industry 'gold standard' in the assessment of quality of life in PD patients. The 39-point PDQ provides scores on 8 scales: mobility, activities of daily living, emotions, stigma, social support, cognition, communications and bodily discomfort.

Systematically querying I (non-motor aspects of activities of daily living), II (motor aspects of activities of daily living) and IV (motor complications)

Ron Postuma

Neurologist

Canadian Institutes of Health Research (CIHR)

Coltect contains natural compounds: curcumin, green tea and selenium which are approved as food supplements by the Ministry of Health in Israel. Curcumin and green tea are widely used in the food industry.

Ulcerative Colitis

Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.

camellia rosthorniana/headache

Stroke in Korean Young Adults Study

The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach

Caffeine for Motor Manifestations of Parkinson's Disease

The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

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