The purpose of this study determined if oral supplementation of Protandim® (a nutraceutical) for 90 days improved 5-km running performance and reduced serum thiobarbituric acid-reacting substances (TBARS) at rest, an indicator of oxidative stress. Secondary objectives were to measure whole blood superoxide dismutase (SOD), glutathione (GSH), and glutathione peroxidase (GPX), at rest and 10 minutes after completion of the race before and after supplementation as well as quality of life. In a double-blind, randomized, placebo controlled trial, 38 runners [mean (SD) = 34 (7) yrs; BMI = 22 (2) kg/m2] received either 90 days of Protandim® [1 pill a day, n = 19)] or placebo (n = 19). Randomization was done in blocks of two controlling for sex and 5-km baseline performance. A 5-km race was performed at baseline and after 90 days of supplementation, with blood samples taken before and 10-min after each race. Fasting blood samples were acquired at baseline, after 30, 60, and 90 days of supplementation. TBARS, SOD, GPX, and GSH were assayed in an out-of-state accredited lab. Running performance was not altered by Protandim® or placebo [20.3 (2.1) minutes, with an -8 (33) seconds change in 5-km time regardless of group]. There was no change in TBARS, SOD, or GPX (at rest) after three months of Protandim® supplementation compared to placebo. However, in a subgroup ≥ 35 years of age, there was a 2-fold higher increase in SOD in those taking Protandim® for three months compared to those on placebo (p = 0.038). The mean post-race change in TBARS (compared to pre-race) increased by about 20% in half of the subjects, but was not altered between groups, even after three months of supplementation. Quality of life was also not different between the two conditions. In conclusion, Protandim® did not (1) alter 5-km running time, (2) lower TBARS at rest (3) raise antioxidant enzyme concentrations compared to placebo (with exception of SOD in those ≥ 35 years old) or, (4) affect quality of life compared to placebo.Trial Registration: ClinicalTrials.gov NCT02172625

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BackgroundRegular exercise training can enhance antioxidant defense mechanisms. Supplements that may further increase these antioxidant defense mechanisms could be of value to athletes. Protandim® is a nutraceutical made of 5 plant extracts. One pill contains 225 mg milk thistle, 150 mg bacopa extract, 150 mg ashwagandha, 75 mg turmeric, and 75 mg of green tea, which has been shown to increase antioxidant enzymes such as superoxide dismutase (SOD), catalase, hemoxygenase and gluthathione.ObjectiveTo determine whether taking Protandim® orally for 90 days would improve 5‐km running performance in regional‐class runners. A secondary objective was to look at blood anti‐oxidant enzymes [glutathione (GSH), glutathione peroxidase (GPX), and SOD] and serum thiobarbituric acid‐reacting substances (TBARS) as an indicator of oxidative stress at rest and 10 minutes after the completion of the run.DesignIn a double‐blind, randomized, placebo‐controlled trial, 38 healthy runners [mean (SD) = 34 (7) yrs; BMI = 22 (2) kg/m2] were randomized to receive 90 days of Protandim® (1 pill a day) or placebo. A 5‐km race was performed at baseline and after 90 days of supplementation, with blood samples being acquired before and 10‐min after each race. Fasting (non‐exercise) blood samples were acquired at baseline and after 30, 60, and 90 days of supplementation. Race time, serum GSH, GPX, SOD and TBARS were analyzed using a repeated‐measures ANOVA.ResultsRunning performance was not altered by Protandim® or placebo supplementation [20.3 (2.1) minutes, with an −8 (33) seconds change in 5‐km time regardless of group, p=0.84 between groups]. There was no statistically significant change in fasting or pre‐post run serum SOD, GSH, or GPX overtime, within or between groups (all p>0.05). Mean fasting serum TBARS were normal [8.1 (2.0) μmol/L] and remained unchanged with Protandim® or placebo supplementation. The post‐race change in TBARS (compared to pre‐race) was not altered between groups, even after 88 days of supplementation [Protandim®, post ‐ pre change = +0.1 (1.7) μmol/L prior to supplementation, +0.1 (1.2) μmol/L after 88 days of Protandim®; Placebo, post ‐ pre change = +0.5 (1.9) μmol/L prior to supplementation, −0.9 (4.8) μmol/L after 88 days of placebo] (all p>0.05).ConclusionRegular supplementation with Protandim® did not alter 5‐km running performance. Protandim® supplementation did not statistically change blood antioxidant enzymes in these runners. As a whole, the 5‐km race did not induce oxidative stress as seen by serum TBARS which remained normal (<10 μmol/L). Further studies are warranted to examine intracellular levels of antioxidants or mitochondrial function in these type of subjects rather than measuring serum free radical load and antioxidants levels.ClinicalTrials.gov Identifier: NCT02172625Support or Funding InformationThis study was supported by an industry grant from LifeVantage Corporation