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Protandim

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Protandim is a patented dietary supplement marketed by LifeVantage Corporation (OTCBB: LFVN; formerly LifeLine Therapeutics and Yaak River Resources, Inc), a Utah-based multilevel marketing company.[1] The manufacturers of Protandim claim the product can indirectly increase antioxidant activity by upregulating endogenous antioxidant factors such as the enzymes superoxide dismutase (SOD) and catalase, as well as the tripeptide glutathione, and by activation of Nrf2. Like all dietary supplements, Protandim has not been evaluated by the U.S. Food and Drug Administration (FDA) and "is not intended to diagnose, treat, cure, or prevent any disease."[2]

LifeVantage Management

  • Douglas C. Robinson, President and Chief Executive Officer
  • David W. Brown, President (Chief Executive Officer from 2008-2011)
  • Kirby Zenger, Chief Operating Officer
  • Carrie McQueen, Chief Financial Officer
  • Joe M. McCord, Chief Science Officer

Protandim Composition

Protandim was invented by Paul R. Myhill and William J. Driscoll.[3] The product was originally produced under a manufacturing agreement with The Chemins Company of Colorado Springs, Colorado.[4] In July 2008, LifeVantage entered into a new manufacturing agreement with Cornerstone Research & Development, Inc. to produce Protandim, and with Wasatch Product Development, LLC to produce True Science skin cream.[5]

The product consists mainly of a blend of 5 ingredients (amounts per caplet listed in parentheses):

Additional ingredients include: calcium, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, modified cellulose, silica, and stearic acid.

Protandim Side Effects

According to the manufacturer, the side effects of Protandim may include allergic responses, gastrointestinal disturbances (stomach ache, diarrhea, vomiting), headache, and rash of the hands and feet.[6]

Research

Overview

Nine research studies of Protandim have been published as of 2011; all but two[7][8] were conducted in in vitro or in vivo animal models. Six of the studies were conducted, written, and/or funded in whole or in part by LifeVantage and its predecessor Lifeline Therapeutics.[7][9][10][11][12][8]

Lifevantage advertises Protandim as a Nrf2 activator.[13] A 2003 study showed that Nrf2 and heme oxygenase 1 are induced by low doses of curcumin, (a chemical constituent of turmeric and one of the principal ingredients in Protandim) in isolated kidney epithelial cells.[14]

A 2008 review article noted that Protandim is one of many supplements that claim to act as antioxidants, but that changes in TBARS levels and increases in the levels of antioxidant enzymes in response to a treatment do not provide a reliable indication that the treatment has an antioxidant effect, since the same responses are produced by pro-oxidant compounds that induce oxidative stress. The authors suggested that measurement of isoprostanes might be a better indication of lipid peroxidation and oxidative damage to DNA.[15]

A review by Science-Based Medicine of eight peer-reviewed studies found insufficient evidence to support its usefulness. Dr. Harriet Hall states, "We simply don’t know enough at this point to recommend Protandim for treatment or prevention of any disease, for anti-aging, for making people feel healthier or more energetic, or for anything else."[16]

Human Clinical Studies

Two studies of Protandim have been conducted in humans subjects. One of these studies, a non-randomized, non-controlled trial, reported that Protandim increased the levels of the antioxidant enzymes SOD and catalase while reducing TBAR levels.[7][17]

The second study, a double-blinded, randomized, placebo-controlled trial published by McCord and colleagues in 2012, examined the effect of Protandim on pulmonary oxidative stress and alveolar epithelial permeability in 30 recovering alcoholics.[8] Protandim (14 subjects at a dose of 1350 mg/day; double the daily dose recommended by the manufacturer) or placebo (in 16 subjects) were administered for 7 days. Relative to placebo-treatment, Protandim had no significant effects on alveolar epithelial permeability or on oxidative stress, epithelial growth factor, fibroblast growth factor, interleukin-1β, and interleukin-10 levels in bronchoalveolar lavage fluid. Treatment with placebo, however, produced a significant reduction in plasma levels of TBARs, a marker of oxidative stress (i.e., lipid peroxidation).

In vitro and animal studies

In studies published by LifeVantage executive Joe McCord and colleagues, it was reported that Protandim increased glutathione levels in isolated cells[9] and that intraperitoneal injection of an alcohol-based extract of Protandim could suppress skin tumor incidence in an experimental model in mice[10][18] and result in suppression of p53 and induction of MnSOD in isolated mouse epidermal cells in vitro.[18]

An in vitro gene expression microarray study published by Dr. McCord and associates in 2011 examined the effect of Protandim on gene expression profiles in human primary vascular endothelial cells and a SK-N-MC human neuroblastoma-derived cell line. Protandim was found to upregulate Nrf-2 and to modulate the expression of a variety of other genes.[19]

Another study conducted by Dr. McCord and associates investigated the effect of intraperitoneal injection of an alcohol-based extract of Protandim in an experimental model of pulmonary hypertension in rats. It was reported that the extract induced myocardial nuclear factor E2-related factor 2 and heme oxygenase 1, prevented a loss of myocardial capillaries, minimized fibrosis and preserved RV function [20]

Other studies by McCord and colleagues have examined the effects of Protandim on fibrosis in a rodent model of Duchenne muscular dystrophy (DMD)[11] and the effects of an alcohol extract of Protandim in an in vitro saphenous vein graft model.[21] In a study investigating the effects of various agents on skeletal muscle tissue function in an in vitro model of DMD, compounds used clinically for DMD treatment, such as the glucocorticoids, were found to produce a potentially beneficial increase in muscular contractile force, while Protandim produced the opposite effect, significantly inhibiting contractile force.[22]

In 2009, LifeVantage was sued by Utah-based Zrii LLC, a marketer of nutritional fruit drinks endorsed by Deepak Chopra, based on allegations that LifeVantage had conspired with former Zrii executives to “ruin the company” and take it over “on the cheap” following a “mass exodus” of Zrii distributors to LifeVantage. The case was closed in December 2009 following LifeVantage’s settlement payment of $400,000 to Zrii.[23]

On October 14, 2011, Burke Hedges, a former high-level LifeVantage distributor, filed a lawsuit with the Utah District Court against LifeVantage and its executives, seeking $3 million in punitive damages over allegations of wrongful termination and tortious interference.[24]

Advertising and Sponsorship

On June 20, 2007, LifeVantage announced that it had entered into a 3-year agreement with TV personality Montel Williams to act as a spokesperson for the company’s products.[25] On September 15, 2011, LifeVantage entered into a similar 2-year agreement with entertainer Donny Osmond, stipulating that the company would pay Osmond for various promotional appearances and video recordings and commissions for sales of LifeVantage products.[26]

References

  1. ^ LifeVantage Corporation"www.lifevantage.com". Retrieved 29 March 2010.
  2. ^ This statement or disclaimer is required by US law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label within the United States of America. "FDA: Overview of Dietary Supplements". Retrieved 25 March 2010.
  3. ^ US 7,241,461, Myhill, Paul R. & Driscoll, William J., "Composition for alleviating inflammation and oxidative stress in a mammal.", issued 10 July 2007 
  4. ^ "LIFEVANTAGE CORP - 10KSB/A [Filed 06 January 2006]". sec.edgar-online.com. Retrieved 2011-02-05.
  5. ^ http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=8164388-16511-132473&type=sect&dcn=0001193125-11-258536
  6. ^ "FAQ". protandim.com.
  7. ^ a b c Nelson, Sally K.; Bose, Swapan K.; Grunwald, Gary K.; Myhill, Paul; McCord, Joe M. (2006). "The induction of human superoxide dismutase and catalase in vivo: A fundamentally new approach to antioxidant therapy". Free Radical Biology and Medicine. 40 (2): 341–7. doi:10.1016/j.freeradbiomed.2005.08.043. PMID 16413416.
  8. ^ a b c "Protandim(R) does not influence alveolar epithelial permeability or intrapulmonary oxidative stress in human subjects with alcohol use disorders". Am J Physiol Lung Cell Mol Physiol. Jan 20. [Epub ahead of print]. 2012. PMID 22268125. {{cite journal}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)
  9. ^ a b Velmurugan, K; Alam, J; McCord, J; Pugazhenthi, S (2009). "Synergistic induction of heme oxygenase-1 by the components of the antioxidant supplement Protandim". Free Radical Biology and Medicine. 46 (3): 430–40. doi:10.1016/j.freeradbiomed.2008.10.050. PMID 19056485.
  10. ^ a b Liu, Jianfeng; Gu, Xin; Robbins, Delira; Li, Guohong; Shi, Runhua; McCord, Joe M.; Zhao, Yunfeng (2009). "Protandim, a Fundamentally New Antioxidant Approach in Chemoprevention Using Mouse Two-Stage Skin Carcinogenesis as a Model". PLoS ONE. 4 (4): e5284. doi:10.1371/journal.pone.0005284. PMC 2668769. PMID 19384424.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  11. ^ a b Qureshi, Muhammad Muddasir; McClure, Warren C.; Arevalo, Nicole L.; Rabon, Rick E.; Mohr, Benjamin; Bose, Swapan K.; McCord, Joe M.; Tseng, Brian S. (2010). "The Dietary Supplement Protandim® Decreases Plasma Osteopontin and Improves Markers of Oxidative Stress in Muscular DystrophyMdxMice". Journal of Dietary Supplements. 7 (2): 159–178. doi:10.3109/19390211.2010.482041. PMC 2926985. PMID 20740052.
  12. ^ Hybertson BM, Gao B, Bose SK, McCord JM (2011 Oct 15. (Epub ahead of print)). "Oxidative stress in health and disease: The therapeutic potential of Nrf2 activation". Mol Aspects Med. 32 (4–6): 234–46. doi:10.1016/j.mam.2011.10.006. PMID 22020111. {{cite journal}}: Check date values in: |date= (help)CS1 maint: multiple names: authors list (link)
  13. ^ {{cite web |url=http://www.protandim.com/faq/ |title=FAQ |publisher=protandim.com
  14. ^ Balogun E, Hoque M, Gong P, Killeen E, Green CJ, Foresti R, Alam J, Motterlini R (2003). "Curcumin activates the haem oxygenase-1 gene via regulation of Nrf2 and the antioxidant-responsive element". Biochem J. 371 (10): 887–95. doi:10.1042/BJ20021619. PMC 1223348. PMID 12570874.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  15. ^ Knasmüller, Siegfried; Nersesyan, Armen; Mišík, Miroslav; Gerner, Christopher; Mikulits, Wolfgang; Ehrlich, Veronika; Hoelzl, Christine; Szakmary, Akos; Wagner, Karl-Heinz (2008). "Use of conventional and -omics based methods for health claims of dietary antioxidants: a critical overview". British Journal of Nutrition. 99: ES3–52. doi:10.1017/S0007114508965752. PMID 18503734.
  16. ^ Hall, Harriet. "Pursued by Protandim Proselytizers". Science-Based Medicine. Retrieved 12 November 2011.
  17. ^ Alison McCook (2006). "Your Money for Your Life". The Scientist. 20 (3): 33. {{cite journal}}: Unknown parameter |month= ignored (help)
  18. ^ a b Robbins D, Zhao Y (23 March 2011). "The role of manganese superoxide dismutase in skin cancer". Enzyme Res. Epub: 409295. doi:10.4061/2011/409295. PMC 3092576. PMID 21603266.{{cite journal}}: CS1 maint: unflagged free DOI (link) Cite error: The named reference "robbins" was defined multiple times with different content (see the help page).
  19. ^ http://www.sciencedirect.com/science/article/pii/S0098299711000501
  20. ^ Bogaard, H. J.; Natarajan, R.; Henderson, S. C.; Long, C. S.; Kraskauskas, D.; Smithson, L.; Ockaili, R.; McCord, J. M.; Voelkel, N. F. (2009). "Chronic Pulmonary Artery Pressure Elevation Is Insufficient to Explain Right Heart Failure". Circulation. 120 (20): 1951–1960. doi:10.1161/CIRCULATIONAHA.109.883843. PMID 19884466.
  21. ^ Joddar, Binata; Reen, Rashmeet K.; Firstenberg, Michael S.; Varadharaj, Saradhadevi; McCord, Joe M.; Zweier, Jay L.; Gooch, Keith J. (2011). "Protandim attenuates intimal hyperplasia in human saphenous veins cultured ex vivo via a catalase-dependent pathway". Free Radical Biology and Medicine. 50 (6): 700–9. doi:10.1016/j.freeradbiomed.2010.12.008. PMID 21167278.
  22. ^ Vandenburgh H, Shansky J, Benesch-Lee F, Skelly K, Spinazzola JM, Saponjian Y, Tseng BS (2009). "Automated drug screening with contractile muscle tissue engineered from dystrophic myoblasts". FASEB J. 23 (10): 3325–34. doi:10.1096/fj.09-134411. PMID 19487307.{{cite journal}}: CS1 maint: multiple names: authors list (link) CS1 maint: unflagged free DOI (link)
  23. ^ Harvey, Tom (12/23/2009). "Supplement company Zrii settles suits against rebellious ex-managers: LifeVantage pays $400,000 in dispute stemming from failed takeover attempt". Salt Lake Tribune. Retrieved 6 November 2011. {{cite web}}: Check date values in: |date= (help)
  24. ^ "Burke Hedges V. Lifevantage Corporation". United States District Court for the District of Utah: Civil No. 110918424. October 14, 2011. {{cite web}}: |access-date= requires |url= (help); Missing or empty |url= (help)
  25. ^ "Montel Williams and LifeVantage Corporation Sign License Agreement to Promote Science-Based Dietary Supplement Products". LifeVantage Press Release. Retrieved February 15, 2012.
  26. ^ "LFVN Form 8-K". SEC.gov. September 20, 2011. Retrieved November 7, 2011.
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