The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

Completed · Not applicable · Has a placebo group

Conditions studied: Oxidative Stress

In brief

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.

Key facts

Study ID

NCT02172625

Run by

University of Louisville

People needed

40

Starts

2014-11-01

Expected to finish

2016-06-01

Last updated by the study team

2019-02-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, non-pregnant subjects between 18 and 55 years of age. Apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association
• http://circ.ahajournals.org/content/97/22/2283/T6.expansion.html
• Subjects have to achieve a classification of "local class" based on age-graded time USA Track \& Field. The age-graded time is the finish time adjusted to that of an open division participant using a factor for age and gender. Thus, the times for women and older participants are adjusted downward, while the times for most open division participants (such as 25-year-old men) remain the same. For example, a 55 year old woman has to run 29 minutes 45 seconds or better to be in the study:
• http://www.usatf.org/statistics/calculators/agegrading/
• For a man the same age, the equivalent time would be 25 minutes 2 seconds. This is approximately 60% of the speed of the current world record time for that age.
• Subjects who will abstain from taking any nutritional supplements for the duration of the study, including vitamins and mineral supplements (Exception, ferrous sulfate, elemental iron, Vitamin D, Calcium). Subjects will also abstain from taking any over the counter products (herbals, melatonin, St. John's Wort, etc…) for the duration of the study.
• The exclusion criteria will be the following:
• Under 18 and over 55 years of age; those who are not apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association.
• Subjects who are not able to run 5-km in the time required for their age and gender.
• Subjects that will continue to take nutritional supplements, including over the counter products, for the duration of the study, including vitamins and mineral supplements (exception: Ferrous sulfate, Elemental iron, Vitamin D, Calcium).
• Subjects that are taking prescription medications with the exception of birth control.
• Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family.

Where it is running

• Crawford Gym, Room 17a, University of Louisville — Louisville, Kentucky, United States

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