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The Clinical Study on Protandim
In this study, before starting Protandim, men and women study participants, who ranged in age from 20 to 78, showed a strong age-related increase in TBARS (a specific measure of oxidative stress). Lower levels of TBARS are seen in healthy and younger individuals. As people age, and in certain diseases, the amount of TBARS circulating in the blood increases, indicating elevated oxidative stress levels.
After 30 days of taking Protandim, a 40 percent average decrease in TBARS was seen, and the age-related increase was eliminated. By 120 days of supplementation, Protandim® also significantly increased activity of SOD and CAT antioxidant enzymes by 30 percent and 54 percent, respectively.
"These results show not only that specific harmful substances can be decreased by Protandim®, but that oxidative stress can be reduced by a natural process, increasing the body’s ability to get rid of the harmful substances by increasing the activity of antioxidant enzymes," said Dr. McCord.
LifeVantage's corporate approach to the science of oxidative stress is that they believe today’s consumers of dietary supplements are asking for more scientific data to demonstrate the value of the products they choose. It is their goal to continue supporting research not only to help differentiate Protandim® as a unique approach to antioxidant therapy, but also to further define the science behind oxidative stress.
View a pdf of the clinical study.
This article appears on Protandim.com with permission from Elsevier. They can be reached directly by going to www.sciencedirect.com/science.
The Protandim Clinical Trial in Detail
When clinical studies are conducted, researchers are required to conduct a 'power analysis' to determine the minimum number of patients required to show the effectiveness of a drug treatment or intervention. For Protandim, a power analysis was conducted (based on a previous animal study which is common practice for pharmaceutical and supplement products) to determine the sample size for a human study. The result of the power analysis for Protandim showed that a human study including at least 13 patients would give statistically significant results.
A significant lowering of TBARS with just 13 patients enrolled in our original study was in fact seen. We elected to add more patients (a total of 29) because we wanted to look for other markers for oxidative stress including but not limited to TBARS.
Some clinical studies use large patient populations because a larger sample size generally leads to parameter estimates with smaller variances, giving you a greater ability to detect a significant difference. For example if you were testing the efficacy of a drug that shows a difference of 5-10% with a specific treatment, then a power analysis would show that you might possibly need 100-300 patients to show a significant effect. With Protandim, we had a huge difference of 40-50% and therefore did not require a large patient population to show significance.
The Protandim study was conducted for a full 120 days because the life span of a red blood cell is 120 days. Blood samples are a more viable means of analysis in a human study (as opposed to tissue samples).By conducting the Protandim study over the full life cycle of a red blood cell, it is understood that 100% of the red blood cells in circulation in the body at 120 days will reflect increased levels of |
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