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Trial record 41 of 3400 for:    Louisville

The Effect of Protandim Supplementation on Oxidative Damage and Athletic Performance

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ClinicalTrials.gov Identifier: NCT02172625
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Gerald S Zavorsky, PhD, University of Louisville

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.


Condition or disease Intervention/treatment Phase
Oxidative Stress Dietary Supplement: Protandim Dietary Supplement Other: Placebo Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of 90 Days of Protandim Supplementation on Markers of Oxidative Stress, Athletic Performance, and Recovery
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Group
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
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.
Other Name: Control Group

Experimental: Protandim Dietary Supplement
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
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.
Other Names:
  • Protandim Group
  • Experimental Group




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Glutathione Peroxidase (GPX) [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]
    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.

  2. Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief) [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]

    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).

  3. Total Antioxidant Capacity (TAC) [ Time Frame: Baseline and 88 (SD 4) days. All pre-exercise values. ]
    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.

  4. Whole Blood Glutathione Content (GSH) [ Time Frame: Baseline and 88 (SD 4) days. All pre-exercise values. ]
    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.

  5. Superoxide Dismutase (SOD) [ Time Frame: Baseline, 30 days, 57 days, and 88 days ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. 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

  2. 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.

  3. 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:

  1. 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.
  2. Subjects who are not able to run 5-km in the time required for their age and gender.
  3. 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).
  4. Subjects that are taking prescription medications with the exception of birth control.
  5. Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172625


Locations
United States, Kentucky
Crawford Gym, Room 17a, University of Louisville
Louisville, Kentucky, United States, 40292
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Gerald S Zavorsky, PhD University of Louisville

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Gerald S Zavorsky, PhD, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02172625     History of Changes
Other Study ID Numbers: 14.0614
First Posted: June 24, 2014    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified data is in SPSS format placed as a supplement in the published PLOS ONE article: http://dx.doi.org/10.1371/journal.pone.0160559

Keywords provided by Gerald S Zavorsky, PhD, University of Louisville:
Athletic performance
Running
Dietary supplementation
Quality of life
Running performance
oxidative damage