ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02172625
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Gerald S Zavorsky, PhD, University of Louisville

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Oxidative Stress
Interventions: Dietary Supplement: Protandim Dietary Supplement
Other: Placebo Group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
40 subjects were recruited. 2 subjects were excluded. 1 not meeting inclusion criteria, and 1 declined to participate. Thus, 38 subjects were randomized into either the Protandim Group (n = 19) or Placebo Group (n = 19)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sugar Pill

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.

Protandim Dietary Supplement

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.


Participant Flow:   Overall Study
    Sugar Pill   Protandim Dietary Supplement
STARTED   19   19 
COMPLETED   19   16 
NOT COMPLETED   0   3 
Adverse Event                0                1 
Pregnancy                0                1 
car accident                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill

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.

Protandim Dietary Supplement

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.

Total Total of all reporting groups

Baseline Measures
   Sugar Pill   Protandim Dietary Supplement   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 35  (8)   34  (6)   34  (7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      10  52.6%      8  42.1%      18  47.4% 
Male      9  47.4%      11  57.9%      20  52.6% 
Region of Enrollment 
[Units: Participants]
     
United States   19   19   38 
Region of Enrollment 
[Units: Participants]
     
United States   19   19   38 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 64.6  (11.1)   68.1  (11.4)   66.4  (11.2) 
Fasting Blood Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 89  (9)   90  (5)   90  (7) 


  Outcome Measures

1.  Primary:   5-km Running Time   [ Time Frame: Baseline and 88 (SD 4) days ]

Measure Type Primary
Measure Title 5-km Running Time
Measure Description 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
Time Frame Baseline and 88 (SD 4) days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Runners from the Louisville, KY, USA, community

Reporting Groups
  Description
Sugar Pill 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 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).

Measured Values
   Sugar Pill   Protandim Dietary Supplement 
Participants Analyzed   19   16 
5-km Running Time 
[Units: Minutes]
Mean (Standard Deviation)
   
Baseline   20.2  (2.0)   20.4  (2.3) 
88 days Post-supplementation   20.0  (2.1)   20.1  (2.7) 

No statistical analysis provided for 5-km Running Time



2.  Primary:   Lipid Peroxides (TBARS)   [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]

Measure Type Primary
Measure Title Lipid Peroxides (TBARS)
Measure Description 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
Time Frame Baseline, 30 days, 57 days, and 88 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The values reported here are the values in a fasted state. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559

Reporting Groups
  Description
Sugar Pill 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 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).

Measured Values
   Sugar Pill   Protandim Dietary Supplement 
Participants Analyzed   19   16 
Lipid Peroxides (TBARS) 
[Units: umol/L]
Mean (Standard Deviation)
   
TBARS, rest, baseline   7.8  (1.8)   8.1  (2.0) 
TBARS, rest, 30 (SD 2) days post-supplementation   8.2  (2.2)   8.0  (3.5) 
TBARS, rest, 57 (SD 2) days post-supplementation   8.0  (2.6)   9.5  (5.1) 
TBARS, rest, 88 (SD 4) days post-supplementation   7.9  (4.0)   7.1  (2.3) 
TBARS, 10-min post-exercise, Baseline   8.5  (2.5)   8.5  (2.4) 
TBARS, 10-min post-exercise, 88 days post-suppl   6.8  (2.5)   7.5  (2.6) 


Statistical Analysis 1 for Lipid Peroxides (TBARS)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
week-to-week coefficient of variation % [3] 26
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.



3.  Secondary:   Glutathione Peroxidase (GPX)   [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]

Measure Type Secondary
Measure Title Glutathione Peroxidase (GPX)
Measure Description 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.
Time Frame Baseline, 30 days, 57 days, and 88 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill 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 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).

Measured Values
   Sugar Pill   Protandim Dietary Supplement 
Participants Analyzed   19   16 
Glutathione Peroxidase (GPX) 
[Units: U/g Hb]
Mean (Standard Deviation)
   
GPX, fasted, rest, baseline   28.4  (7.4)   27.8  (4.6) 
GPX, rest, 30 (SD 2) days post-supplementation   28.7  (7.2)   27.5  (4.0) 
GPX, rest, 57 (SD 2) days post-supplementation   29.0  (5.3)   28.6  (4.1) 
GPX, rest, 88 (SD 4) days post-supplementation   31.9  (7.8)   31.0  (4.4) 


Statistical Analysis 1 for Glutathione Peroxidase (GPX)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
week-to-week coefficient of variation % [3] 15
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.



4.  Secondary:   Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)   [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]

Measure Type Secondary
Measure Title Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)
Measure Description

This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.

  1. Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).
  2. Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).
  3. Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).
  4. Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable).
Time Frame Baseline, 30 days, 57 days, and 88 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Healthy community runners.

Reporting Groups
  Description
Placebo Group

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.

Protandim Group 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).

Measured Values
   Placebo Group   Protandim Group 
Participants Analyzed   19   19 
Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief) 
[Units: Units on a scale]
Mean (Standard Deviation)
   
Physical Health, Baseline   27.6  (5.2)   27.2  (4.4) 
Physical Health, 30 (2) days post-supplementation   28.0  (4.5)   24.3  (4.6) 
Physical Health, 57 (2) days post-supplementation   27.1  (4.8)   27.0  (4.6) 
Physical Health, 88 (4) days post-supplementation   28.4  (4.1)   27.1  (4.8) 
Psychological Health, Baseline   22.8  (5.2)   22.4  (3.9) 
Psychological Health 30 days post-supplementation   23.4  (4.5)   22.7  (4.4) 
Psychological Health 57 days post-supplementation   23.4  (4.6)   22.5  (4.2) 
Psychological Health, 88 days post-supplementation   23.6  (4.9)   22.2  (4.4) 
Social Health, Baseline   11.9  (3.7)   12.2  (2.2) 
Social Health, 30 days post-supplementation   12.1  (2.1)   12.5  (2.1) 
Social Health, 57 days post-supplementation   12.3  (2.9)   12.1  (2.1) 
Social Health, 88 days post-supplmentation   12.6  (3.0)   11.9  (2.5) 
Environmental Health, Baseline   34.6  (6.2)   32.6  (4.0) 
Environmental Health, 30 days post-supplmentation   32.1  (5.0)   33.1  (4.7) 
Environmental Health, 57days post-supplementation   32.3  (4.8)   32.1  (5.1) 
Environmental Health, 88 days post-supplementation   35.5  (4.6)   32.2  (4.8) 

No statistical analysis provided for Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)



5.  Secondary:   Total Antioxidant Capacity (TAC)   [ Time Frame: Baseline and 88 (SD 4) days. All pre-exercise values. ]

Measure Type Secondary
Measure Title Total Antioxidant Capacity (TAC)
Measure Description 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.
Time Frame Baseline and 88 (SD 4) days. All pre-exercise values.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Runners from the Louisville, KY, USA, community

Reporting Groups
  Description
Sugar Pill 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 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).

Measured Values
   Sugar Pill   Protandim Dietary Supplement 
Participants Analyzed   19   16 
Total Antioxidant Capacity (TAC) 
[Units: mmol/L]
Mean (Standard Deviation)
   
Baseline   0.86  (0.06)   0.86  (0.07) 
88 days Post-supplementation   0.80  (0.06)   0.80  (0.07) 

No statistical analysis provided for Total Antioxidant Capacity (TAC)



6.  Secondary:   Whole Blood Glutathione Content (GSH)   [ Time Frame: Baseline and 88 (SD 4) days. All pre-exercise values. ]

Measure Type Secondary
Measure Title Whole Blood Glutathione Content (GSH)
Measure Description 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.
Time Frame Baseline and 88 (SD 4) days. All pre-exercise values.  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Runners from the Louisville, KY, USA, community

Reporting Groups
  Description
Sugar Pill 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 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).

Measured Values
   Sugar Pill   Protandim Dietary Supplement 
Participants Analyzed   19   16 
Whole Blood Glutathione Content (GSH) 
[Units: umol/L x 10]
Mean (Standard Deviation)
   
Baseline   102  (19)   103  (13) 
88 days Post-supplementation   96  (18)   104  (30) 

No statistical analysis provided for Whole Blood Glutathione Content (GSH)



7.  Secondary:   Superoxide Dismutase (SOD)   [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]

Measure Type Secondary
Measure Title Superoxide Dismutase (SOD)
Measure Description 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.
Time Frame Baseline, 30 days, 57 days, and 88 days  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill 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 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).

Measured Values
   Sugar Pill   Protandim Dietary Supplement 
Participants Analyzed   19   16 
Superoxide Dismutase (SOD) 
[Units: U/g Hb x 1000]
Mean (Standard Deviation)
   
SOD, fasted, rest, baseline   11.7  (3.6)   11.4  (3.2) 
SOD, rest, 30 (SD 2) days post-supplementation   14.1  (5.7)   15.3  (4.4) 
SOD, rest, 57 (SD 2) days post-supplementation   11.3  (4.7)   9.9  (3.1) 
SOD, rest, 88 (SD 4) days post-supplementation   18.7  (6.2)   20.0  (8.1) 


Statistical Analysis 1 for Superoxide Dismutase (SOD)
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
week-to-week coefficient of variation % [3] 24
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant estimation information:
  This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.




  Serious Adverse Events


  Other Adverse Events

Time Frame Over a period of 3 months (88 days)
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
Sugar Pill 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 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).

Other Adverse Events
    Sugar Pill   Protandim Dietary Supplement
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   4/19 (21.05%)   6/19 (31.58%) 
Gastrointestinal disorders     
Stomach ache † [2]     
# participants affected / at risk   2/19 (10.53%)   5/19 (26.32%) 
# events   2   18 
Diarrhea † [3]     
# participants affected / at risk   1/19 (5.26%)   5/19 (26.32%) 
# events   1   10 
Vomiting † [4]     
# participants affected / at risk   1/19 (5.26%)   2/19 (10.53%) 
# events   2   2 
Gas † [5]     
# participants affected / at risk   4/19 (21.05%)   1/19 (5.26%) 
# events   137   51 
Constipation † [6]     
# participants affected / at risk   1/19 (5.26%)   2/19 (10.53%) 
# events   8   17 
Nausea † [7]     
# participants affected / at risk   2/19 (10.53%)   5/19 (26.32%) 
# events   7   17 
General disorders     
Insomnia † [8]     
# participants affected / at risk   0/19 (0.00%)   1/19 (5.26%) 
# events   0   1 
Head Cold / Congestion † [9]     
# participants affected / at risk   0/19 (0.00%)   1/19 (5.26%) 
# events   0   1 
Metabolism and nutrition disorders     
Low Blood Sugar † [10]     
# participants affected / at risk   0/19 (0.00%)   2/19 (10.53%) 
# events   0   18 
Increased Appetite † [11]     
# participants affected / at risk   1/19 (5.26%)   0/19 (0.00%) 
# events   1   0 
Musculoskeletal and connective tissue disorders     
Joint Pain † [12]     
# participants affected / at risk   3/19 (15.79%)   2/19 (10.53%) 
# events   6   12 
Nervous system disorders     
Headache † [13]     
# participants affected / at risk   3/19 (15.79%)   6/19 (31.58%) 
# events   12   40 
Drowsiness † [14]     
# participants affected / at risk   4/19 (21.05%)   2/19 (10.53%) 
# events   17   3 
Dizziness † [15]     
# participants affected / at risk   2/19 (10.53%)   5/19 (26.32%) 
# events   5   33 
Skin and subcutaneous tissue disorders     
Itching † [16]     
# participants affected / at risk   0/19 (0.00%)   1/19 (5.26%) 
# events   0   8 
Events were collected by systematic assessment
[2] Stomach Ache
[3] Diarrhea
[4] Vomiting
[5] Gas
[6] Constipation
[7] Nausea
[8] Insomnia
[9] Head Cold / Congestion
[10] Low Blood Sugar
[11] Increased Appetite
[12] Joint Pain
[13] Headache
[14] Drowsiness
[15] Dizziness
[16] Itching



  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • Serum TBARS to detect lipid peroxidation is not specific.
  • TBARS may have been measured too quickly post-exercise.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gerald S. Zavorsky
Organization: Georgia State University
phone: 404-413-1271
e-mail: zavorsky@gsu.edu


Publications of Results:
Other Publications:

Responsible Party: Gerald S Zavorsky, PhD, University of Louisville
ClinicalTrials.gov Identifier: NCT02172625     History of Changes
Other Study ID Numbers: 14.0614
First Submitted: June 20, 2014
First Posted: June 24, 2014
Results First Submitted: August 14, 2016
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017