NCT02172625

The Effect of 90 Days of Protandim Supplementation on Markers of Oxidative Stress, Athletic Performance, and Recovery

Completed NA Results posted Last updated 23 January 2019

What this trial tests

NA trial testing Protandim Dietary Supplement in Oxidative Stress in 40 participants. Completed in 1 June 2016.

Timeline

1 November 2014

Primary endpoint
1 June 2015

1 June 2016

Quick facts

Lead sponsor	University of Louisville
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	40
Start date	1 November 2014
Primary completion	1 June 2015
Estimated completion	1 June 2016
Sites	1 location across United States

Drugs / interventions tested

• Protandim Dietary Supplement
• Placebo Group

Conditions studied

• Oxidative Stress — all drugs for Oxidative Stress →

Sponsor

University of Louisville

Who can join

Adults 18 to 55, any sex, with Oxidative Stress. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 5-km Running Time
  Time frame: Baseline and 88 (SD 4) days
  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)
  Time frame: Baseline, 30 days, 57 days, and 88 days
  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

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Vistas for the Nutraceutical <i>Withania somnifera</i> in Inflammaging.
   Basudkar V, Gujrati G, Ajgaonkar S, Gandhi M, et al · · 2024 · cited 17× · PMID 38794167 · DOI 10.3390/ph17050597
2. The Effect of Protandim® Supplementation on Athletic Performance and Oxidative Blood Markers in Runners.
   Ueberschlag SL, Seay JR, Roberts AH, DeSpirito PC, et al · · 2016 · cited 9× · PMID 27513339 · DOI 10.1371/journal.pone.0160559
3. Correction: The Effect of Protandim® Supplementation on Athletic Performance and Oxidative Blood Markers in Runners.
   Ueberschlag SL, Seay JR, Roberts AH, DeSpirito PC, et al · · 2020 · cited 1× · PMID 33096544 · DOI 10.1371/journal.pone.0241520