'The Right Approach'

TRA COMPLEX AND ITS COMPOSITION

What is TRA Complex?
TRA Complex is a synergistic blend of ingredients designed to be an integral part of the Pharmanex Weight Management Program. This proprietary formula helps promote weight loss by working on multiple metabolic processes including normal glucose/insulin response management, thermogenesis, and cortisol management. TRA Complex is completely stimulant free, making it the right approach to losing weight safely, simply and effectively.*

What are the health benefits?
To produce effective weight loss, a dietary supplement should work through several mechanisms, including, (1) Thermogenesis, the physiological production of heat to burn calories; (2) normal healthy glucose/insulin response, which helps reduce the desire for carbohydrates; (3) and cortisol management, which helps deter the body's tendency to store fat. Controlling these three metabolic conditions, on top of an appropriate diet and exercise program, gives people the added effect of changing their metabolism so that they can lose weight.*

Where do other weight loss programs fail?
There are thousands of weight loss programs, foods, and dietary supplements on the market today. The truth is, most weight management approaches fail because our bodies adapt to create defense systems to thwart efforts on only one regulatory system. That's why it is important to target weight management with a synergistic, whole body approach that addresses the wide variety of factors contributing to weight management.

What is the recommended adult use?
As a dietary supplement, take three (3) capsules three times daily, preferably with each meal.

Who should use TRA Complex?
TRA Complex is recommended for weight conscious individuals desiring effective weight loss.

What ingredients does TRA Complex provide?
TRA Complex combines the key active ingredients from CortitrolÒ, CraveEase™, and Tegreen 97Ò, along with calcium.

What makes TRA Complex unique?
TRA Complex provides a comprehensive approach to effective weight loss by addressing multiple mechanisms. The forms and dosages of ingredients are provided at levels supported by scientific studies, and each ingredient is standardized for consistent benefits.*

How is TRA Complex standardized?
The constituents in TRA Complex are standardized through scientific and analytical methods to ensure that every capsule contains the specific level of constituents, every time. Tegreen 97Ò, is standardized to 97% polyphenols, two-thirds of which are catechins. Magnolia bark is standardized to 2% honokiol. Epimedium is standardized to a 6:1 water extract. L-Theanine is standardized to a 70:1 extract. Banaba leaf is standardized to 1% corosolic acid.

What is the difference between TRA Complex and HTP Complex?
TRA Complex is a comprehensive weight loss supplement addressing cortisol control, thermogenesis, and normal, healthy glucose/insulin response. Those individuals desiring enhanced appetite control can combine HTP Complex with TRA Complex.*

MECHANISMS OF ACTION

Which ingredients provide the thermogenic effect in TRA Complex?
TRA Complex contains green tea catechins (from Tegreen 97Ò) and calcium to support thermogenesis.

Green Tea Catechins
Several recent studies have documented a thermogenic effect of green tea with and without caffeine. Studies by Dulloo indicate that the thermogenic effects of green tea are due to properties beyond caffeine content (Dulloo 2000, Dulloo 1999). The clinical study showed that the green tea extract increased 24-hour energy expenditure (which relates to thermogenesis and metabolic rate) and fat oxidation in humans more than caffeine alone or placebo. In addition, a study highlighted at the April 2003 FASEB meeting discussed the results of a new animal model study that reveal the benefits of Tegreen 97Òin improving lipid and glucose metabolism, maintaining normal insulin sensitivity, and balancing the metabolic rate of fat deposit and fat burning (Zhu 2003).*

Calcium
Studies indicate that calcium intake accounts for about 3-10%% of the variability of BMI (Heaney 2002). In a review, each 300 mg increment in regular calcium intake was associated with approximately 1 kg less body fat in children and 2.5-3.0 kg lower body weight in adults. Data suggest that increasing calcium intake by the equivalent of two dairy servings per day could reduce the risk of overweight substantially, perhaps by as much as 70 percent (Heaney 2002). Dietary calcium plays a pivotal role in the regulation of energy metabolism by reducing the level of calcium in human adipocytes. Low-calcium diets stimulate the influx of Ca2+ into human adipocytes and thereby promotes fat storage and adiposity, while high dietary calcium increases lipolysis and preserves thermogenesis, helping enhance weight loss (Zemel 2002). *

Which ingredients provide the cortisol modulating effects in TRA Complex?
TRA Complex provides a number of ingredients to that have been shown to directly and/or indirectly modulate cortisol levels, including magnolia bark, epimedium, L-theanine, and phytosterol esters (beta-sitosterol).

Cortisol is known as a stress hormone, and can exert good or bad effects in the body. Cortisol has various effects on the body including the release of glucose and amino acids for cellular energy, and is closely associated with the "fight or flight" response. Whenever we're under stress, whenever we're sleep-deprived, or whenever we're actually dieting and restricting our calories for weight loss, our body senses that it is under stress, and it releases the primary stress hormone, cortisol. Cortisol becomes a hormonal signal to your brain to make you eat more. It increases your appetite. But it is also a hormonal signal to your fat cells, telling the fat cells in your abdomen to store as much fat as possible, and not release it under any circumstances. By bringing cortisol back into a normal range, we're able to alleviate that metabolic signal, so your appetite is under better control, your blood sugar continues to remain in control, and your fat cells are in a state where they're more likely to release fat, instead of store fat. *

Many researchers have indicated that elevated cortisol levels in response to stress can lead to weight gain, particularly the harmful abdominal type (Bjorntorp 1995, 1996, 1997, 1999, 2000, 2001, Korbonits 1996, Epel 2000, 2001). It appears reasonable that dietary supplements that help reduce stress and anxiety may also alleviate increases in cortisol, and thus aid in the battle against weight gain, particularly of the abdominal type. *

Magnolia Bark
Magnolia bark (Magnolia officinalis) is a traditional Chinese medicine used since 100 A.D. rich in two biphenol compounds, magnolol and honokiol. These two active compounds are thought to contribute to the primary antistress and cortisol- balancing effects of the plant. Numerous animal studies have demonstrated honokiol to act as an antistress agent at lower doses.

Epimedium
Epimedium is a genus of 21 related plant species. Epimedium is grown as an ornamental herb in Asia and the Mediterranean region. Animal studies have shown that epimedium may function like an adaptogen by promoting healthy levels of epinephrine, norepinephrine, serotonin, and dopamine, but reducing cortisol levels when they are elevated (an antistress effect). Animal studies using epimedium have shown a reduction in bone breakdown, an increase in muscle mass, and a loss of body fat-each of which may be linked to the observed reduction of elevated cortisol to normal levels.*

Theanine
Theanine is a unique amino acid found in the leaves of green tea (Camellia sinensis) and acts as a nonsedating stress reliever to help increase the brain's production of alpha waves. As such, theanine may be effective for combating tension, stress, and anxiety-without inducing drowsiness.*

Phytosterol Esters (Beta-sitosterol)
Beta-sitosterol has a structural similarity to cholesterol, but none of the artery-clogging effects. In the diet, plant oils contain the highest concentration of beta-sitosterol, nuts and seeds contain fairly high levels and all fruits and vegetables generally contain some amount of beta-sitosterol. Beta-sitosterol is found in high levels in fruits, vegetables, nuts, and seeds. Researchers concluded that beta-sitosterol is effective in modulating the stress response by managing cortisol levels within a more normal range. In addition to alleviating much of the postexercise immune suppression that occurs following endurance competitions, beta-sitosterol has also been shown to help maintain the normal ratio of catabolic stress hormones (i.e., those that break down tissue, such as cortisol) to anabolic (rebuilding) hormones such as DHEA.*

Which ingredients provide the glucose/insulin response effects in TRA Complex?
TRA Complex provides Banaba leaf, chromium, and vanadium to help promote a healthy glucose/insulin response. These ingredients have been shown individually to support normal blood glucose and/or hormonal levels under various conditions and may support the maintenance of normal blood glucose levels for the control of food intake.*

Banaba Leaf
Banaba leaf facilitates the body's maintenance of blood sugar and insulin levels already within their normal/desirable range and may help some people resist the urge to snack between meals. Banaba leaf is standardized to corosolic acid, which has been shown to be a glucose transport activator, and is known to have hypoglycemic activity (Grossman 2001). Higher sugar levels within the normal range and chronic insulin levels can lead to increased storage of fats and inhibition of lipase. High levels of insulin and/or reduced blood sugar levels within the normal range can also promote unnecessary cravings, which may lead to bingeing. . Another clinical study found that Banaba leaf supplementation resulted in a mean loss of body weight of 1.25 and 2.4 pounds, after 15 and 30 days, respectively. Two weeks after cessation of Banaba leaf supplementation, an average weight loss of 2.6 pounds was measured.*

Chromium
Chromium acts as a cofactor for insulin and is therefore essential for normal insulin function (Mertz 1993, Anderson 1998, Vincent 1999). Insulin resistance can lead to increased weight gain without increased energy intake. The level of insulin is proportional to body fat content and influences satiety and thermogenesis. Insulin levels have been shown to be maintained within a healthy range by both chromium and vanadium. *

Vanadium
Vanadium has been shown to stimulate glucose uptake, glycogen synthesis, and glucose oxidation in adipose cells and in skeletal muscle (Suzuki 1999). It has also been shown to maintain normal insulin sensitivity in animals (Grossman 2001).*

Are there any studies to substantiate the weight loss effect of TRA Complex?
A number of scientific studies substantiate the role of each nutrient in TRA Complex. Pre-clinical and clinical studies have demonstrated the thermogenic effect of green tea and calcium, the cortisol modulating effect of magnolia bark, epimedium, and phytosterol esters, and the glucose/insulin response effects of Banaba leaf, chromium, and vanadium. References available upon request.

SAFETY

Is this product safe?
TRA Complex is safe at the recommended dosage. Many diet products on the market promote weight loss through use of stimulant-herbs or drugs carry with them the concern of long term health risks. Stimulants can produce irregular and rapid heart beat, and are responsible for two-thirds of all poison control reports nationally. Side effects of stimulants range from the jitters to cardiac arrest. All ingredients used in TRA Complex are stimulant-free, caffeine-free and ephedra-free and will not cause jitters.

All ingredients are tested for purity, and where applicable, ingredients are certified pure by microbial testing, such as tests for Salmonella, E. coli, other coliforms, Staphylococcus aureus, total plate counts, yeasts, molds and pesticide residues. Our manufacturers go through a detailed selection and certification process to assure their compliance with Good Manufacturing Practice (GMP) standards set by the Food and Drug Administration (FDA).

Are there any side effects?
There are no known side effects at the recommended dosage.

Are there any contraindications or drug interactions?
Pregnant or lactating women, diabetics, hypoglycemics, and people with known medical conditions should consult with a physician prior to taking this or any other dietary supplement. Some of the ingredients found in this product (Banaba leaf, chromium, and vanadium) may have positive or negative effects on blood glucose levels, insulin, glucagon, or tissue glucose transporter activity. Therefore, it is especially important that people taking medications such as insulin, glucagon, or any other drug affecting blood glucose levels, consult with their physician prior to taking this supplement.

Because theanine, epimedium, magnolia bark and beta-sitosterol are indicated for stress relief, consult a physician if you are taking prescription "anti-stress" medications such as anxiolytics, sedatives, or hypnotics. Consult a physician if you are taking other CNS depressants, tricyclic antidepressants, anti-epileptics, muscle relaxants, anticoagulants, corticosteroids and quinalone antibiotics. Use of l-theanine concomitantly with chemotherapeutic agents must be done under medical supervision. L-theanine may enhance the effects of doxorubicin, idarubicin, adriamycin, and picarubicin and may ameliorate some of their side effects (PDR for Nutritional Supplements 2001). This supplement should be discontinued two weeks prior to surgery.

No drug interactions specific for green tea polyphenols have been identified. However, one of the catechins, EGCg, has been shown to inhibit collagen-induced platelet aggregation, so individuals taking aspirin or other anticoagulant substances on a daily basis should consult with a physician.

REFERENCES

Anderson RA. Chromium, glucose intolerance and diabetes. J.Am.Coll.Nutr. 1998;17:548-55.
Bjorntorp P, Rosmond R. Hypothalamic origin of the metabolic syndrome X. Ann N.Y.Acad.Sci 1999;892:297-307.
Bjorntorp P, Rosmond R. The metabolic syndrome--a neuroendocrine disorder? Br J Nutr 2000;83 Suppl 1:S49-S57.
Bjorntorp P, Rossner S, Udden J. ["Consolatory eating" is not a myth. Stress-induced increased cortisol levels result in leptin-resistant obesity]. Lakartidningen 2001;98:5458-61.
Bjorntorp P. Body fat distribution, insulin resistance, and metabolic diseases. Nutrition 1997;13:795-803.
Bjorntorp P. Endocrine abnormalities of obesity. Metabolism 1995;44:21-3.
Bjorntorp P. The origins and consequences of obesity. Diabetes. Ciba Found.Symp. 1996;201:68-80.
Dulloo AG, Seydoux J, Girardier L, Chantre P, Vandermander J. Green tea and thermogenesis: interactions between catechin-polyphenols, caffeine and sympathetic activity. Int J Obes Relat Metab Disord. 2000 Feb;24(2):252-8.
Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J. Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 1999 Dec;70(6):1040-5.
Epel E, Lapidus R, McEwen B, Brownell K. Stress may add bite to appetite in women: a laboratory study of stress-induced cortisol and eating behavior. Psychoneuroendocrinology 2001;26:37-49.
Epel ES, McEwen B, Seeman T et al. Stress and body shape: stress-induced cortisol secretion is consistently greater among women with central fat. Psychosom.Med 2000;62:623-32.
Grossman SP. The role of glucose, insulin and glucagon in the regulation of food intake
and body weight. Neurosci Biobehav Rev 2001;??:295-315.
Heaney RP, Davies KM, Barger-Lux MJ. Calcium and weight: clinical studies. J Am Coll.Nutr 2002;21:152S-5S.
Korbonits M, Trainer PJ, Nelson ML et al. Differential stimulation of cortisol and dehydroepiandrosterone levels by food in obese and normal subjects: relation to body fat distribution. Clin Endocrinol.(Oxf) 1996;45:699-706.
Mertz W. Chromium in human nutrition: a review [see comments]. J Nutr 1993;123:626-33.
Suzuki Y, Unno T, Ushitani M, Hayashi K, Kakuda T. Antiobesity activity of extracts from Lagerstroemia speciosa L. leaves on female KK-Ay mice. J Nutr Sci Vitaminol.(Tokyo) 1999;45:791-5.
Vincent JB. Mechanisms of chromium action: Low-molecular-weight chromium-binding substance. J.Am.Coll.Nutr. 1999;18:6-12.
Zemel MB. Regulation of adiposity and obesity risk by dietary calcium: mechanisms and implications. J Am Coll.Nutr 2002;21:146S-51S.
Zhu JS, Yu H, Yin W. Tegreen Improves glucose and lipid metabolism in obese rats that have features similar to Metabolic Syndrome X. Presented at FASEB, April 2003, San Diego, CA.

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THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.