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The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

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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):

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 ]

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

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

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 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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