The Effect of 90 Days of Protandim Supplementation on Markers of Oxidative Stress, Athletic Performance, and Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 5-km Running Time
研究概览
简要总结
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.
详细描述
Forty apparently healthy community runners 18-55 yrs of age was recruited to participate in this study that will require six total visits to the University of Louisville, which included three sessions at the running track at University of Louisville.
A about 120 mL of blood was withdrawn from a peripheral vein for the duration of the study (about 105 days). Runners was recruited from running clubs across the local community. These participants will be randomized into two groups (Protandim, Placebo). The groups will be sex and performance matched after the initial 5-km race.
Each subject underwent six testing sessions.
Session 1 (Initial Screening Day)
Subjects signed consent form and completed a questionnaire to clear them for physical activity. Age, weight, and height was recorded. Subjects was asked to list all the nutritional supplements they are taking, including multivitamins. They were asked to list the 5-km personal best time, and when that was done. They reported most recent 5-km time and when that was achieved. Then they were asked to refrain from taking any multivitamins or nutritional supplements for the duration of the study. The subjects recorded what they ate during the 24 hr prior to the test day, and then they were asked to eat the same thing and do same activity before the all follow up tests. Then a training diary was given to them to fill in for the duration of the study. The training diary included intensity, training duration, and mileage per week. After, they were given six quality of life questionnaires [World Health Organization's WHOQOL-BREF quality of life assessment to fill out at home (one each for Session 1-6)]. A pregnancy test was also conducted in the females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Placebo Group (Other)
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).
干预措施: Protandim Dietary Supplement (Dietary Supplement)
结局指标
主要结局
5-km Running Time
时间窗: 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)
时间窗: 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
次要结局
- 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)
研究者
Gerald S Zavorsky, PhD
Associate Professor
University of Louisville