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NCT02172625 · ClinicalTrials.gov registry record · NA
The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance
A NA study of Oxidative Stress, sponsored by University of Louisville.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02172625: Completed NA study of Oxidative Stress, sponsored by University of Louisville.
NCT02172625 is a NA study of Oxidative Stress that has completed, run by University of Louisville. The registered enrollment target is 40 participants, below the 85-participant average among 36 other Oxidative Stress trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02172625, a NA study of Oxidative Stress, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Nutrition supplementation with antioxidants have been discussed as a way to further enhance overall well-being of athletes, promote faster recovery, and improve overall performance. The use of Protandim, a nutritional supplement containing 5 botanicals (Bacopa extract 150 mg; milk thistle 225mg; ashwagandha 150 mg; green tea 75 mg; turmeric 75 mg) has shown promise in an earlier study by reducing oxidative stress and increasing the amount of the anti-oxidant enzymes in the blood. The purpose of this study was to examine the effect of \~90 day Protandim supplementation on 5-km running performance and on acute and long term oxidative damage as assessed by blood markers. Secondarily, another purpose of this study examined the effect of Protandim supplementation on other blood parameters (such as antioxidant enzyme concentrations) and measures of quality of life. The experiment was double-blind, placebo controlled. The study addressed two main questions and two secondary questions: Main Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) improve 5-km running times? Hypothesis: Protandim would improve 5-km running time by 0.5 min (SD 1-min). This is equivalent to an effect size of 0.5. The placebo group will have no change in performance. Main Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) reduce oxidative damage at rest as assessed by lipid peroxides (TBARS) in runners? Hypothesis: Based on the data by Nelson et al. (2006), oxidative damaged would be reduced by 40% (effect size = 4.8). Secondary Question 1: Does regular supplementation of Protandim (675 mg/day for 90 days) in runners reduce the increase in oxidative damage post-race compared to pre-race as assessed by lipid peroxides (TBARS)? Hypothesis: Based on the data by Kyparos et al. (2009), we expected a 45% increase in TBARS post-exercise compared to pre-exercise (effect size of 3.6). However, we expected that those that are on Protandim for 90 days
Primary Outcome
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
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Protandim Dietary Supplement
- OTHER Placebo Group
Study Locations (1)
Kentucky
- Crawford Gym, Room 17a, University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT02172625 record still lists
NCT02172625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 85-participant average among 36 other Oxidative Stress trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Oxidative Stress appearing as the primary indexed condition, and to 2 interventions - of which Protandim Dietary Supplement is the first listed.
NCT02172625 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT02172625 about?
NCT02172625 is a clinical study titled "The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance". Nutrition supplementation with antioxidants have been discussed as a way to further enhance overall well-being of athletes, promote faster recovery, and improve overall performance. The use of Protandim, a nutritional supplement containing 5 botanicals (Bacopa extract 150 mg; milk thistle 225mg; ash...
What is the current status of trial NCT02172625?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2014-11. Estimated completion is 2016-06.
What conditions does trial NCT02172625 study?
This clinical trial studies the following conditions: Oxidative Stress.
What interventions are being tested in trial NCT02172625?
The interventions under investigation include: Protandim Dietary Supplement (DIETARY_SUPPLEMENT), Placebo Group (OTHER).
Who is sponsoring clinical trial NCT02172625?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02172625 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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40 18th of 36 higher than 17 of 36 other Oxidative Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oxidative Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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