The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance
NCT02172625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2019-02-12
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 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.
Conditions
- Oxidative Stress
Interventions
- DIETARY_SUPPLEMENT
-
Protandim Dietary Supplement
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.
- OTHER
-
Placebo Group
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.
Sponsors & Collaborators
-
University of Louisville
lead OTHER
Principal Investigators
-
Gerald S Zavorsky, PhD · University of Louisville
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2015-06-30
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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