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Friday, March 2, 2012

Protandim - The Human Cure-All?

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. 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."

Protandim was invented by Paul R. Myhill and William J. Driscoll. The product was originally produced under a manufacturing agreement with The Chemins Company of Colorado Springs, Colorado. 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.

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

Milk thistle (Silybum marianum) extract (225 mg)
Bacopa (Bacopa monniera) extract (150 mg)
Ashwagandha (Withania somnifera) root (150 mg)
Green tea (Camellia sinensis) extract (75 mg)
Turmeric (Curcuma Ionga) extract (75 mg)

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

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.

Nine research studies of Protandim have been published as of 2011; all but two 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.

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.

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.

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."

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.

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

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.

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.

Other studies by McCord and colleagues have examined the effects of Protandim on fibrosis in a rodent model of Duchenne muscular dystrophy (DMD) and the effects of an alcohol extract of Protandim in an in vitro saphenous vein graft model. 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.

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

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