Trial Outcomes & Findings for The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance (NCT NCT02172625)

40 subjects were recruited. 2 subjects were excluded. 1 not meeting inclusion criteria, and 1 declined to participate. Thus, 38 subjects were randomized into either the Protandim Group (n = 19) or Placebo Group (n = 19)

The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

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

Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC \[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571\]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.

This is a questionnaire that assessed quality of life across 4 domains over the supplementation period. 1. Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable). 2. Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable). 3. Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable). 4. Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable).

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC\[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571\]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC \[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571\]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.

Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC \[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571\]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.