The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance
Public ClinicalTrials.gov record NCT02172625. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
The Effect of 90 Days of Protandim Supplementation on Markers of Oxidative Stress, Athletic Performance, and Recovery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 will only have 31% increase in TBARS post-race (effect size = 2.5) \[based on changes in pre-post lipid peroxides from Arent et al. (2010)\]. Secondary Question 2: Does regular supplementation of Protandim (675 mg/day for 90 days) improve quality of life according to WHOQOL-BREF (Skevington, Lotfy, O'Connell, \& Group, 2004)? Hypothesis: There would be a statistical improvement in the quality of life post-Protandim supplementation which a small effect size improvement of 0.33.
Study identification
- NCT ID
- NCT02172625
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- Protandim Dietary Supplement Dietary Supplement
- Placebo Group Other
Dietary Supplement · Other
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2014
- Primary completion
- May 31, 2015
- Completion
- May 31, 2016
- Last update posted
- Feb 11, 2019
2014 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Crawford Gym, Room 17a, University of Louisville | Louisville | Kentucky | 40292 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02172625, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02172625 live on ClinicalTrials.gov.