The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

NCT02172625 | Completed Results DMC

• 1 other identifier: 14.0614
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Athletic performance; Running; Dietary supplementation; Quality of life; Running performance; oxidative damage

Outcome Measures

Primary Outcomes (2)

• 5-km Running Time

  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

  Baseline and 88 (SD 4) days

• Lipid Peroxides (TBARS)

  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

  Baseline, 30 days, 57 days, and 88 days

Secondary Outcomes (5)

• Glutathione Peroxidase (GPX)

  Baseline, 30 days, 57 days, and 88 days

• Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)

  Baseline, 30 days, 57 days, and 88 days

• Total Antioxidant Capacity (TAC)

  Baseline and 88 (SD 4) days. All pre-exercise values.

• Whole Blood Glutathione Content (GSH)

  Baseline and 88 (SD 4) days. All pre-exercise values.

• Superoxide Dismutase (SOD)

  Baseline, 30 days, 57 days, and 88 days

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator

Other: Placebo Group

Protandim Dietary Supplement

EXPERIMENTAL

Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).

Dietary Supplement: Protandim Dietary Supplement

Interventions

Protandim Dietary Supplement 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.

Also known as: Protandim Group, Experimental Group

Protandim Dietary Supplement

Placebo Group OTHER

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.

Also known as: Control Group

Placebo Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Crawford Gym, Room 17a, University of Louisville

Louisville, Kentucky, 40292, United States

Location

Related Publications (7)

• Arent SM, Pellegrino JK, Williams CA, Difabio DA, Greenwood JC. Nutritional supplementation, performance, and oxidative stress in college soccer players. J Strength Cond Res. 2010 Apr;24(4):1117-24. doi: 10.1519/JSC.0b013e3181cb70b8.

  PMID: 20300015 BACKGROUND

• Kyparos A, Vrabas IS, Nikolaidis MG, Riganas CS, Kouretas D. Increased oxidative stress blood markers in well-trained rowers following two thousand-meter rowing ergometer race. J Strength Cond Res. 2009 Aug;23(5):1418-26. doi: 10.1519/JSC.0b013e3181a3cb97.

  PMID: 19620924 BACKGROUND

• Kabasakalis A, Kyparos A, Tsalis G, Loupos D, Pavlidou A, Kouretas D. Blood oxidative stress markers after ultramarathon swimming. J Strength Cond Res. 2011 Mar;25(3):805-11. doi: 10.1519/JSC.0b013e3181d0b109.

  PMID: 20613649 BACKGROUND

• Nelson SK, Bose SK, Grunwald GK, Myhill P, McCord JM. The induction of human superoxide dismutase and catalase in vivo: a fundamentally new approach to antioxidant therapy. Free Radic Biol Med. 2006 Jan 15;40(2):341-7. doi: 10.1016/j.freeradbiomed.2005.08.043.

  PMID: 16413416 BACKGROUND

• Mullins AL, van Rosendal SP, Briskey DR, Fassett RG, Wilson GR, Coombes JS. Variability in oxidative stress biomarkers following a maximal exercise test. Biomarkers. 2013 Aug;18(5):446-54. doi: 10.3109/1354750X.2013.810668.

  PMID: 23862764 BACKGROUND

• Jeukendrup AE, Currell K. Should time trial performance be predicted from three serial time-to-exhaustion tests? Med Sci Sports Exerc. 2005 Oct;37(10):1820; author reply 1821. doi: 10.1249/01.mss.0000175095.56646.4b. No abstract available.

  PMID: 16260987 BACKGROUND

• Ueberschlag SL, Seay JR, Roberts AH, DeSpirito PC, Stith JM, Folz RJ, Carter KA, Weiss EP, Zavorsky GS. The Effect of Protandim(R) Supplementation on Athletic Performance and Oxidative Blood Markers in Runners. PLoS One. 2016 Aug 11;11(8):e0160559. doi: 10.1371/journal.pone.0160559. eCollection 2016.

  PMID: 27513339 RESULT

Related Links

• Protandim Web-link
• Natural Standards Database
• Age-Gender Performance Grading for 5-km

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

* Serum TBARS to detect lipid peroxidation is not specific. * TBARS may have been measured too quickly post-exercise.

Results Point of Contact

• Title: Dr. Gerald S. Zavorsky
• Organization: Georgia State University

zavorsky@gsu.edu

404-413-1271

Study Officials

• Gerald S Zavorsky, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: February 12, 2019
• Results First Posted: January 9, 2017

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)