UofL Design and Print

The World Health Organization Quality of Life (WHOQOL-BREF) is an assessment frequently used in clinical trials in order to ascertain an individual’s overall quality of life evaluated through four different domains: Physical Health, Social Relationships, Psychological Health and Environmental1. There are currently no studies evaluating the effects of Protandim supplementation on quality of life. A double-blind placebo-controlled study sought to determine the effects of 90 days of Protandim supplementation on WHOQOL-BREF in regional class runners.

Thirty eight apparently healthy subjects (age = 34 ±7yrs; body mass index = 22 ± 2 kg/m2; 5-km running time = 20.3 ± 2.1 minutes) participated in this study. The subjects were placed into one of two groups: an experimental (675mg/day of Protandim which contains 225 mg of milk thistle, 150mg of bacopa extract, 150mg dose of ashwagandha root, 75mg of turmeric, and 75mg green tea) or control group (675mg/day corn starch) by stratified random sampling in blocks of two matched for gender and 5-km running performance. The WHOQOL-BREF was completed by subjects at home before each of two initial baseline sessions, then at 30, 60, and 90 days ∼ ∼ ∼post supplementation. The long term effects of supplementation were analyzed using a Kruskal-Wallis ANOVA.

The week-to-week coefficient of variation in quality of life scores for both baseline sessions varied from 5 to 7% for the four domains. After 88 ± 4 days of supplementation, there were no significant differences between groups in Physical Health, Social Relationships, or Psychological Health domains. However, at 88 days post-supplementation, the placebo group showed slightly higher Environmental domain scores when compared to the Protandim group (p=0.047). Regular supplementation of Protandim (675mg/day for 88 days) did not improve nor worsen quality of life in runners according to the WHOQOL-BREF. However, at 88 days post-supplementation, the placebo group had significantly higher Environmental domain scores when compared to the Protandim group.

THREE MONTHS SUPPLEMENTATION OF PROTANDIM DOES NOT AFFECT QUALITY OF LIFE IN RUNNERS

Alexandra H. Roberts1, Seteena L. Ueberschlag1, James R. Seay1, Rodney J. Folz1, Kathleen A. Carter1, Edward P. Weiss2, Gerald S. Zavorsky1

1University of Louisville, Louisville KY; 2Saint Louis University, Saint Louis, MO.

CONCLUSIONS

ABSTRACT

To the study committee for continued support and feedback; our study participants for their time; and the members of the research team for their effort and expertise. The research team would also life to thank LifeVantage Inc. for providing us with the placebo and Protandim supplements and for funding this research study.

ClinicalTrials.gov Identifier: NCT02172625

Running ProtocolFor this study, a total of 40 males and females, 20-46 years of age were

recruited from running clubs across the local community. Subjects were instructed to record dietary intake for the 24-hrs prior to each session, and were asked to consume similar diets prior to all sessions.

Participants were randomly divided into two groups based on their sex and performance on their 5-km performance time. Subjects were asked to refrain from taking any multivitamins or nutritional supplements for the duration of the study. Subjects were then given a 90 day supply of either Protandim or a placebo.

Participants completed the WHOQOL-BREF at home the day before sessions 2-6. All WHOQOL-BREF results were coded by trained investigators.

No observed difference in Domain 2 (Psychological Health) (mean + SD) between baseline tests.

METHODS

INTRODUCTIONQuality of life is a subjective measure of health and well-being frequently

used by those in the health fields to assess an individual’s satisfaction with various domains of their lives. The full quality of life measure from the World Health Organization (WHOQOL-100) consists of 100 items throughout six domains, and has been shown to be highly reliable.

The brief version (WHOQOL-BREF) has been developed to decrease the burden on subjects completing it to allow for more accurate results in some clinical trials1. The domains covered in the WHOQOL-BREF are Physical Health, Social Relationships, Psychological Health and Environmental1. Bergner noted that during clinical trials, recording and examining quality of life is imperative in order to understand and quantify all potential side-effects or benefits2.

There are currently no studies into the effects of regular Protandim supplementation on quality of life.

TimelineSession 1

Day 0 Session 2Day 15

Session 3Day 21

Session 4Day 51

Session 5Day 81

Session 6Day 111

Consent form/ PARQ signed

Explain study to subjects

Anthropometric

Paperwork

Completed WHOQOL-

BREF

5km Time Trial

Completed WHOQOL-

BREF

5km Time Trial

Supplement given

Completed WHOQOL-

BREF

Completed WHOQOL-

BREF

Completed WHOQOL-

BREF

5km Time Trial

Statistical Analyses

In conclusion, this study demonstrated the following finding:

1. Regular supplementation of Protandim did not improve, nor worsen, quality of life according to the WHOQOL-BREF16. However, at 88 days post-supplementation, the Placebo group had significantly higher environmental domain scores compared to the Protandim group.

Acknowledgements

Research Question and HypothesisDoes regular supplementation of Protandim (675mg/day for 90 days)

improve any one of the four domains of quality of life according to the WHOQOL-BREF?

It is hypothesized that there will be a statistically significant improvement in the quality of life post-Protandim supplementation.

RESULTS

No observed difference in Domain 3 (Social Relationships) (mean + SD) between baseline tests.

No observed difference in Domain 2 (Environmental) (mean + SD) between baseline tests.

No observed difference in Domain 1 (Physical Health) (mean + SD) between baseline tests.

Raw scores from the WHOQOL-BREF

* p = 0.047 b/w groups for Environment at 88 Days post supplementation

References1. Skevington et al. Qual Life Res, 13: 299-310. 2. Bergner. Med Care, 27(3): S148-S156