Protandim FAQ and Clinical Studies

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What is Protandim?
To the best of our knowledge, Protandim is the only supplement in the world clinically proven (in a peer-reviewed, human clinical study) to reduce aging factors by an average of 40 percent. Protandim has been awarded three patents, and is the subject of more than 20 independent clinical studies at the present time.
This patented anti-oxidant therapy is many times more powerful than red wine, oranges, blueberries, juices or other popular antioxidant supplements.
When Protandim was first formulated, it was considered by most to be an antioxidant supplement, although not a conventional one. But that is no longer an adequate description.
Protandim is actually a Nrf2 activator in the nutrigenomics arena. Nutrigenomics is the science of how dietary components interact with the genome, or DNA, to regulate gene expression. Nutrigenomics studies how the things we eat affect our genes. Nrf2 is one of the key proteins in the body and regulates approximately 500 of the 25,000 genes in the body. 

Think of every gene as having a “dimmer switch.” Nrf2 is the protein that can reach the dimmer switch. Protandim helps your body balance and regulate its 25,000 genes by “turning some up” or “turning some down.”
It isn’t simply the most unique antioxidant supplement on the market… It’s an Nrf2 activator.

 

 

What does Protandim do?
Protandim works by increasing the body’s natural antioxidant protection at the cellular level, triggering cells to produce naturally occurring protective antioxidant enzymes such as superoxide dismutase (SOD), catalase, and the enzymes involved in glutathione synthesis and metabolism.

 

What are the immediate benefits of Protandim?
The immediate benefits of Protandim are experienced within several days. The biochemical markers of oxidative stress begin to decrease, and while there are immediate improvements, you may not sense that these things are happening – just as you cannot sense what your cholesterol level is, whether it is high or low.
Why should I take Protandim long term?
The advantages of taking Protandim over the long term are that it protects your body from the relentless progression of free radical damage as we age. The anti-aging aspect of Protandim is one that accumulates over time, so that the longer you take it, the more protection you will sustain.
Does Protandim interfere with other supplements?
Protandim does not interfere with other supplements. If you have a desire to supplement vitamins and minerals, you certainly can continue to do that.

 

Can Protandim be given to children?
Protandim can be given to children. Dr. McCord states that children under the age of 20 generally do not need Protandim, unless they have an oxidative stress related condition.
Can Protandim be taken with prescription medication?
There are no known adverse drug interactions caused by Protandim. We recommend always checking with your doctor prior to use.
Can I return Protandim if I want to for any reason?
Yes, there is a 30 day money back guarantee.
What happens if I stop taking Protandim? Am I worse off than before?
If you stop taking Protandim, your body will return to its previous level of fighting free-radicals and oxidative stress within 14 days.

 

Will I notice any effects from taking Protandim?
Effects vary, but common shared experiences are a stronger immune system and a greater well-being.
Will I need to take Protandim for the rest of my life?
That’s a personal decision only you can make. What we can tell you is that continuing to take Protandim can be a good choice if you want to continue to achieve the results of triggering the cells in your body to produce naturally occurring protective antioxidant enzymes such as superoxide dismutase (SOD), catalase, and the enzymes involved in glutathione synthesis and metabolism.
Are there any times for which Protandim is contraindicated?
Yes, during chemotherapy or after an organ transplant. *See more below.
Does Protandim effect uric acid levels?
The induction of human superoxide dismutase and catalase in vivo study states that no statistically significant change in uric acid was produced. If your uric acid is measured on two successive days it will not be the same. The reference (normal) range for uric acid is 3.6 to 8.3 mg/dl. A 5% fluctuation shown in the study, even if it were mathematically significant (which it isn’t) would not be clinically significant.

 

Does the human body build up a tolerance to Protandim where after a period of time users will need to increase their intake to achieve the same result?
No tolerance is built up to Protandim over time.
How is Protandim different from other antioxidant supplements?
Protandim is different from other antioxidant supplements because it is among the very first of the products that are appearing and will appear as Nrf2 activators. As far as we know, Protandim is the first potent Nrf2 activator that is commercially available.
Nrf2 is a protein messenger contained in every cell of the body that sends information to the cell’s DNA. When this protein messenger called Nrf2 is activated, it enters the nucleus of every cell and turns on several hundred of these 25,000 genes, collectively known as survival genes. Protandim, as a Nrf2 activator, activates survival genes, such as antioxidant genes that keep us safe from free radicals and oxidants and also turns down genes that perpetuate inflammation and genes that encourage slow, progressive fibrosis to occur. Together, these actions provide a remarkable promise of protection from many kinds of age-related diseases.
Protandim is different from other antioxidant supplements in the way it works. Instead of providing the body with additional dietary antioxidants (regular supplements fall into this category and are commonly called consumable or “direct” antioxidants), Protandim works from within your body– signaling it to boost its own production of numerous antioxidant enzymes (including the well-known ones—SOD and catalase) that already exist at the cellular level to help fight free radicals and cellular aging. This is why Protandim is significantly more effective than any other antioxidant on the market today; your body is actually producing the antioxidant power. But Protandim goes far beyond antioxidant protection; it activates hundreds of “survival genes” that help your body survive many kinds of stress.

 

 

Protandim, an Nrf2 Activator?
Protandim’s actions result from its ability to activate the transcription factor known as Nrf2. Protandim contains 5 ingredients that are known to scientists as Nrf2 activators. Nrf2 is a protein messenger contained in every cell of the body that sends information to the cell’s DNA. That DNA consists of about 25,000 genes and the products of those genes make you who you are and what you are. There’re unique for each person. DNA is what makes you a human being, what gives you your personality, what gives you your physical traits.
When this protein messenger called Nrf2 is activated, it enters the nucleus of every cell and it turns on several hundred of these 25,000 genes. And the genes that it turns on, or turns up, are known collectively as “survival genes.” What is a survival gene? These genes enable cells to survive in the face of several different kinds of stress, especially oxidative stress which is due to the over production of free radicals and other oxidants.
Nrf2 also affects another hundred or so genes by turning them down, not up. Included in these genes are pro-inflammatory and pro-fibrotic genes.
Inflammation accompanies many different disease processes. Everyone is familiar with inflammatory diseases like arthritis, but any time you get traumatic injuries, you sprain your ankle, bruise yourself, there is swelling and pain and redness that characterize inflammation. The process of inflammation is designed, in part, to prevent infection. One of the ways your body prevents infection is to kill invading microorganisms by intentionally making toxic free radicals. Thus the pain, redness and swelling in a cut are not so much from infection, but from inflammation as your body responds to the possibilities of an infection.

 

What are Pro-Fibrotic genes?
Following inflammation in many kinds of diseases or traumatic injury is a process of scar tissue formation that scientists refer to as “fibrosis”. A number of genes turn on that process. And while fibrosis can be a good thing if you’re healing a cut, in many other diseases it is a bad thing. For example, many older people die each year from heart failure– the failure of the pumping action of the heart due to this process of fibrosis. This is quite a different process from “hardening of the arteries” or atherosclerosis, which leads to heart attacks and strokes.
So, Protandim, as a Nrf2 activator, activates survival genes, such as antioxidant genes that keep us safe from free radicals and oxidants. It also turns down genes that perpetuate inflammation and genes that encourage slow, progressive fibrosis to take place. Together, these actions provide a remarkable promise of protection from many kinds of age-related diseases.
Protandim is among the very first of the products that are appearing, and will appear, as Nrf2 activators. It is, as far as we know, the first potent Nrf2 Activator that is commercially available.

 

 

Are vitamins C and E or CoQ10 Nrf2 Activators?
Vitamin C is not a Nrf2 Activator. Vitamin E and CoQ10 are very, very weak activators at high doses and in cultured cells. It’s not clear if these compounds have practical Nrf2 activating activity in intact animals, or whether sufficiently high concentrations could be reached.
I drink special juices and eat fruits and vegetables for my antioxidants. Why do I need Protandim?
Many people mistakenly believe their antioxidant needs are fulfilled by eating blueberries, drinking expensive “miracle juices”, and applying antioxidant facial creams. What they don’t realize is that their daily antioxidant needs cannot be fulfilled by consuming any amount of blueberries, dark chocolate or red wine. Effective antioxidant protection absolutely requires adequate production of the body’s own antioxidant enzymes.
As much fun as it would be to eat 15 pounds of chocolate daily, it would be impossible. Protandim is the only solution available to provide the necessary amount of antioxidants. Protandim, an all natural dietary supplement that holds three patents, has been proven to decrease oxidative stress by an average of 40 percent and has been peer reviewed in a published, human clinical study.

 

Why do people age and how can Protandim help slow that process?
Nationally recognized anti-aging expert Dr. Joe McCord explains, “Researchers and scientists agree that aging is the result of cellular deterioration caused by free radicals, which are rogue molecules. It is impossible to avoid free radicals because the food you eat and the air you breathe, as well as stress or even vigorous exercise, can stimulate cells to produce destructive free radicals in staggering numbers. With each year, a person’s body becomes less effective at fighting free radicals. It’s a vicious cycle, programmed into genes, which results in aging, disease and eventually death. A person’s body fights free-radicals by producing its own antioxidant enzymes. But as we grow older, our bodies produce more free radicals and less of these antioxidant enzymes to fight the battle of aging. That’s where Protandim plays a critical role. Protandim boosts the body’s own production of antioxidant enzymes at the cellular level with enough neutralizing capacity to eliminate the age-related increase in free radical damage.”

 

What are the main ingredients found in Protandim?
Milk Thistle Extract containing 80% silymarin, Bacopa Extract containing 45% bacosides, Ashwagandaha root powder, Green Tea Extract containing 98% polyphenols, Tumeric Extract containing 95% curcumin.

 

Are the ingredients used in Protandim “organic?
No, they are not “certified” organic. However, they are all harvested in their natural pure environment.
What are the origins of the raw materials?
Ashwahangha – India, Bacopa – India, Green Tea- China, Milk Thistle – China, Tumeric – India.
Are the raw materials tested?
Yes, the raw materials are tested for: Pesticides/Herbicides; Heavy Metals; Active Compound in 5 Active Ingredients (for example, we test Bacopa for Bacosides and Turmeric for Curcumonoids); All Microbial tests; and, Efficacy/Bioavailability.
The pill is so yellow. Are dyes or food colorings in Protandim?
No, there are no dyes or food colorings in Protandim. One of the active ingredients, curcumin, is intensely yellow.
Can I take these ingredients individually and achieve the same effect?
No, the blend of ingredients and their special formulation is unique to Protandim and holds three patents. The combination of ingredients creates a synergy that has been studied and proven to provide much more antioxidant power than any food or conventional supplements. This scientific peer-reviewed study was published in the journal “Free Radical Biology and Medicine” and it also clearly shows Protandim produces a 300 percent increase in glutathione, which is a key antioxidant and anti-aging factor.

 

Does the milk thistle (silymarin) in Protandim have estrogen-like effects?
No. The estrogenic effects of silymarin are well studied. Below is the abstract of a study that found no binding of silymarin to the estrogen receptor alpha (ERalpha). Binding to ERalpha would be a cause for concern in estrogen-sensitive breast or uterine cancer patients. Silymarin is an agonist (positive effector) for the ERbeta receptor, whereby it can positively affect bone density.
Reference: Seidlova-Wuttke, D.; Becker, T.; Christoffel, V.; Jarry, H.; Wuttke, W. Silymarin is a selective estrogen receptor beta (ERbeta) agonist and has estrogenic effects in the metaphysis of the femur but no or antiestrogenic effects in the uterus of ovariectomized (ovx) rats. J. Steroid Biochem. Mol. Biol. 86:179-188; 2003.
What about other ingredients?
Other ingredients: Calcium Carbonate, Croscarmellos Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Modified Cellulose, Silica, Stearic Acid. The cellulose (plant fiber) and other excipients allow the ingredients to hold together when pressed to form a caplet. Magnesium stearate is a natural lubricant that allows the caplet to be released from the die. Another agent keeps the ingredients dry. These same excipients are found in most pressed tablets and caplets.

 

Are we “Standardized”? (”Standardized” is a term used when a nutritional company does testing to ensure that each tablet carries the same amount of each ingredient as listed on the label)?
Yes, we are “Standardized.”
Do we meet Current Good Manufacturing Practices?
Yes, to the best of our knowledge we meet or exceed the Current Good Manufacturing Practices {“cGMPs”) for Nutritional Supplements.
Also, all raw materials are validated before they are purchased. This means we test all inbound raw materials for quality and purity.
Also, Protandim is subject to existing dietary supplement laws, such as the Dietary Supplement Health and Education Act, including adverse event reporting requirements. LifeVantage has established the safety and purity of all its ingredients through independent laboratory testing.

 

Is Protandim “Pharma” (Pharmaceutical) Grade?
No, Protandim is not “Pharma” (Pharmaceutical) Grade. Protandim is a dietary supplement, not a drug.
How about “Pressed” processing?
Yes, the raw ingredients are pressed into tablet form. Our tablets are pressed without any extraneous heat. The only heat that results from the process is from natural friction. There is no raw material degradation from the process. This is considered “cold” pressed or “soft” pressed.
Are there any side effects to taking Protandim?
We do not expect there to be any side effects for the typical consumer who consumes Protandim. Yet, some individuals have natural allergic responses to one or another of the ingredients, just as some people are allergic to pine pollen or penicillin. These allergic responses to Protandim generally appear as gastrointestinal disturbances (ie, stomach ache, diarrhea, vomiting) or sometimes as a headache or rash on the hands or feet. The symptoms disappear if Protandim is discontinued, and so far, none have required medical treatment. Some of those experiencing these side-effects or allergies have been able to continue with Protandim at a half dose. Others simply cannot take Protandim.
Any side-effect occurring within ten (10) minutes is unlikely due to Protandim. It may take an hour or two before the caplet dissolves and the gene induction effects of Protandim require many hours to begin.

 

Should I continue to take my other vitamins and antioxidants?
Some western diets are lacking in certain nutritional elements, so multivitamin supplementation may be beneficial for some people. You can discontinue supplementing with antioxidants, however, because Protandim is more effective at eliminating free radical damage than supplementation with conventional antioxidants.

 

Are there situations where Protandim is not recommended?
Protandim is not recommended during chemotherapy or radiation therapy for cancer. Why not? Because chemotherapy and radiation therapy are designed to kill (cancer) cells by causing oxidative stress. After cancer chemotherapy and radiation therapy, Protandim is then strongly recommended because the rest of the body then needs to repair itself and recover.
* Protandim is also not recommended for people taking Immunosuppressive drugs following a transplanted organ. Why? Normally, we all want to have a strong, robust immune system. But because the immune system is what helps you fight off viruses and bacteria, and other foreign substances, you don’t want a strong, robust immune system if you have just received an organ that is foreign to your body. If you do, your immune system can try to reject it–try to kill it the same as it would try to kill any invading microorganism. So, people who have undergone organ transplants or are on any Immunosuppressive drugs to turn down their immune system should wait to take Protandim until after they have discontinued their drugs. They should not take anything that will crank up their immune system, and Protandim may do exactly that. And while this may not be ideal, it may help keep the newly transplanted organ.
Protandim is a very powerful product. So although our goal at LifeVantage is to share Protandim with every home in the world, there are situations where taking Protandim is not recommended. We just wanted to make you aware of them for your continued good health.

 

Does Protandim interfere with any prescription drugs?
The ingredients in many supplements are metabolized in the liver and excreted by the kidneys in the urine just like prescription drugs, the ingredients in Protandim are primarily metabolized and excreted by the liver into the bile. This difference decreases the likelihood of Protandim interacting with other over-the-counter products or with prescription drugs. In fact, after years of public availability and use, we know of no significant drug interaction with Protandim.
Can people take Protandim while taking Coumadin or other blood thinners?
Yes, people on Coumadin can take Protandim without interference. If they test their own clotting time, they should test a day or two after starting Protandim to make sure they don’t need an adjustment in Coumadin dosage. Also, as always, if there is a question, consult your doctor! Note: Surgeons recommend that ALL supplements be stopped before surgery – that is why this is on the label. (See “Prescription Drugs” above).

 

Can people take Protandim while taking Plavix?
Yes. There is no known problem for Plavix users taking Protandim. (See “Prescription Drugs” above).
Can those using a pacemaker use Protandim?
Yes. There is no reason Protandim would interfere with a pacemaker.
Can a woman who is pregnant take Protandim?
Many obstetricians recommend that women stop taking everything except what they prescribe. (See the warning label of the Protandim bottle). However, if your obstetrician approves Protandim, there is no known reason for concern.

 

Can a person overdose on Protandim?
No, the ability to absorb the ingredients is self-limiting, so after a certain point no more is absorbed.
Can a person develop immunity to Protandim?
No, there is no known mechanism whereby Protandim loses effectiveness over time. The formula has not been changed and bioactivity is monitored to maintain consistent potency with regard to the activation of the Nrf2 transcription factor – the mechanism by which Protandim works.

 

What is the shelf life for Protandim?
The shelf life for Protandim is 3 years.
Is it best to take Protandim with or without food?
With food. First of all, there are no foods to avoid. Next, the active ingredients in Protandim are all fat soluble. Although it is not absolutely necessary, taking Protandim with a meal containing some fat allows the ingredients to be absorbed more efficiently.
Is Protandim a controlled substance for which certification is needed, as in the case of professional athletes?
No, although our 5 ingredients are not on the list of banned substances for professional athletes, we do not currently have such a certification.
Is there more information that I find on Protandim?
It is all at your disposal at the PubMed database website, provided by the National Library of Medicine. Just go to PubMed.gov and type in your search parameters. Type “Protandim” and hit Search and you will see all the peer-reviewed studies that have been published so far. Click on any publication that turns up, and you will see a summary (abstract) of the study, and you may have access to the full paper as a PDF file. Type in “oxidative stress cancer” and you will find more than 8,300 papers on the topic. (You may need a PhD to fully understand the papers, but you will be surprised at how much you can understand from a well-written abstract.)

 

Why is the T-BARS assay used to determine levels of oxidative stress?
There are many ways in which oxidative stress can be measured in the laboratory. TBARS was chosen because it has been the most widely used, with more than 8000 published studies. These studies provide a valuable basis for comparison. TBARS reflect oxidative damage to polyunsaturated lipids, perhaps the most sensitive major class of biological molecules to free radical damage.
Do any of the Protandim studies show that it lowers other age related markers besides TBARS?
The last patent issued for Protandim was for the lowering of C-reactive protein levels – a blood test mark
er for inflammation in the body. **See the studies below.
Protandim Studies
What science and clinical proof are behind Protandim?
The science and clinical proof behind Protandim is impressive. In fact, a peer-reviewed, human clinical study showed that after only 30 days of taking Protandim, free radicals decreased an average of 40 percent, slowing the progressive aging factors to the level of a 20 year old. Since the initial peer-reviewed clinical and laboratory studies were published in 2006 and 2009, Protandim has been the subject of more than 20 independent studies at various university and research facilities around the world. Additional peer-reviewed studies have been published. These include: an in vivo study using mice to examine the tumor prevention capabilities of Protandim conducted at Louisiana State University; an in vivo study exploring pulmonary hypertension and subsequent right heart failure conducted at Virginia Commonwealth University; an in vivo study examining the affects of Protandim in mice with muscular dystrophy conducted at Massachusetts General Hospital, Harvard Medical School, and at the University of Colorado; and, the most recent study conducted at Louisiana State University probing Protandim’s ability to modulate the relationship between superoxide dismutase and tumor suppressor p53.

 

 

The second study, completed at the University of Colorado, demonstrated the in vivo antioxidant effects of Protandim (FRBM, 40, 341-347, 2006). The objective of the present study was to determine if the components of Protandim induce heme oxygenase-1 (HO-1) in a synergistic manner in cultured MIN6 cells, a mouse b cell line and SK-N-MC cells, a human neuroblastoma cell line. When the components of Protandim were tested alone at low doses, curcumin showed minimal induction whereas the others were unable to induce HO-1 promoter, assayed by transient transfection. All components together however, produced a strongly synergistic induction of around 3-9 fold in a dose-dependent manner, greatly exceeding the sum of the parts. Similar findings were obtained in the expression of HO-1 at the mRNA and protein levels. Protandim-mediated HO-1 induction involved presence of ARE sites in HO-1 promoter and nuclear translocalization of the transcription factor Nrf2 that binds to ARE sites. Involvement of multiple signaling pathways including PI 3-kinase/Akt, p38MAPK and PKCd in HO-1 induction seems to be the probable mechanism of synergy between the components of Protandim. There were significant increases in the levels of total glutathione in Protandim-treated cells (300% Increase). These findings suggest that use of a combination of phytochemicals may be an efficient method for the induction of antioxidant enzymes.
The third study, completed at Louisiana State University (LSU) and sponsored by the Skin Cancer Foundation, was published in the journal PloS ONE, an international, peer-reviewed, open access journal published by the Public Library of Science. This study, entitled “Protandim, a Fundamentally New Antioxidant Approach in Chemoprevention Using Mouse Two-Stage Skin Carcinogenesis as a Model,” investigated whether Protandim could suppress tumor formation in mice through a dietary approach. At the end of a two-stage skin carcinogenesis, the mice on the Protandim-supplemented diet showed a reduction in both skin tumor incidence and multiplicity by 33% and 57% respectively, compared to those on a basal diet. The study concluded that an induction of antioxidant enzymes by Protandim may serve as a practical and potent approach for cancer prevention.
The fourth study, from Virginia Commonwealth University, was published in Circulation, a prestigious journal of the American Heart Association. This study, entitled “Chronic Pulmonary Artery Pressure Elevation Is Insufficient to Explain Right Heart Failure,” investigated the ability of Protandim to protect the heart in a laboratory model of pulmonary hypertension in rats. Finding that Protandim also prevented the death of heart cells and significantly lowered osteopontin (OPN-1) levels by more than 50%, the researchers found the ability of Protandim to effectively activate the transcription factor Nrf2, a signal to the cell’s DNA to increase expression of a network of antioxidant, anti-inflammatory, and anti-fibrotic genes.
The fifth study, The Dietary Supplement Protandim Decreases Plasma Osteopontin and Improves Markers of Oxidative Stress in Muscular Dystrophy Mdx Mice, was published in the Journal of Dietary Supplements and demonstrated Protandim’s ability to decrease the body’s production of harmful gene products such as osteopontin. This was in addition to its proven ability to increase production of the body’s Nrf2-regulared protective genes, sometimes referred to as “survival genes.” It also concluded that Protandim improves markers of fibrosis in a model of Duchenne Muscular Dystrophy (DMD). The study was performed by Dr. Brian Tseng and his colleagues at Massachusetts General Hospital, Harvard Medical School, and the University of Colorado Denver.
A sixth study, titled “The Chemopreventive Effects of Protandim: Modulation of p53 Mitochondrial Translocation and Apoptosis during Skin Carcinogenesis,” was conducted by researchers at Louisiana State University and published in the scientific journal PloS ONE. The researchers previously reported on the ability of Protandim to reduce both the incidence and the number of skin cancers in mice (see above). That ability was previously demonstrated by the authors in a study involving a mouse two-stage model of chemically-induced skin cancer. Protandim had been shown in earlier studies to activate the transcription factor Nrf2, a signal to the cell’s DNA to regulate a network of protective genes. This new study further investigated Protandim’s ability to increase production of the body’s Nrf2-regulated protective genes, sometime referred to as “survival genes.” This study examined the biochemical mechanisms that underlie the ability of Protandim to suppress tumors in mice.

 

 

 

 

 

 

The Protandim product is currently the subject of more than 20 independent scientific studies at various universities and research facilities. The nature and stages of the studies vary, as some are still in planning stages, while other studies are nearing completion. Universities and institutions conducting research include the University of Colorado; Colorado State University; the University of Utah; Northwestern University; Duke University; Louisiana State University; Ohio State University; Vanderbilt University; Glamorgan University, Wales; Sahlgrenska University Hospital, Sweden;
Harvard University; and the Mexican Institute of Social Security, Mexico City. The various studies deal with the alleviation of oxidative stress under the following conditions: altitude sickness, non-alcoholic steatohepatitis, lung antioxidant status in withdrawing alcoholics, autonomic physiology and aging, skin cancer, multiple sclerosis, pulmonary hypertension, heart disease, coronary artery bypass graft failure, asthma, Duchenne muscular dystrophy, and hearing loss.

 

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