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Prostana DESCRIPTION: two softgels contain the proper doses of ingredients efficacious for maintaining prostate health. Each serving provides a full daily dose of nutrients shown to be effective in stabilizing prostate volume and reducing the symptoms of lower urinary tract problems. FORMULATION: Each serving of 2 gelatin softgels contains Vitamin E (as d-α-tocopherol)………………………………………………………… Zinc (from zinc picolinate)……………………………………………………………… Selenium (from L-selenomethionine).................................................................... Pumpkin seed oil……………………………………………………………………….. Saw palmetto (berry, standardized to 85-95% fatty acids and sterols)…………… Nettle extract (root)…………………………………………………………………….. Pygeum extract (bark)…………………………………………………………………. Phytosterols (44 mg of β-sitosterol)…………………………………………………… Green tea extract (standardized to 95% polyphenols)……………………………… Soy (non-GMO, 40% isoflavones)……………………………………………………… Lycopene (Lyco-Mato®, standardized to 6% lycopene)……………………………… 30 IU 15 mg 70 µg 1200 mg 300 mg 150 mg 100 mg 100 mg 100 mg 50 mg 30 mg DIRECTIONS: Take one softgel twice daily, preferably before or with meals. Store in a cool dry place, keep out of reach of children. INDICATIONS AND COMMON TREATMENTS: benign prostate hyperplasia is quite common among older men in the United States with prostate cancer now the #2 cancer killer. 1. Ultrasound examination of the prostate indicating volume increase. The normal volume for older men may be up to 36 ml, averaging about 20 ml, while volumes larger than 42 ml often indicate pathology. The observed ranges for both conditions are extremely wide and quite dependent on subject weight, equipment and software selected for examination. 2. Total PSA levels (from blood draw) as low as 0.5 µg/L are sometimes associated with benign hyperplasia while levels as low as 1.0 are sometimes observed for subjects suffering cancer even though < 3 µg/L PSA is considered normal. 3. A “gray zone” from 4 to 10 µg/L PSA, indicating either hyperplasia but not necessarily cancer and is usually resolved with biopsy. 4. Prostate volume and symptoms, including urinary incontinence and nocturnal visits can often be successfully treated with nutritional supplements. 5. Surgery remains the only commonly accepted treatment for diagnosed cancer. 6. Around 250,000 prostate cancers are newly diagnosed annually, resulting in a death toll of about 30,000. BACKGROUND: For those with enlarged prostate or hyperplasia blends of herbal extracts with key vitamins and minerals can greatly ameliorate some conditions. Prostana softgels provides several ingredients that work through different pathways to combat enlarged prostate and urinary symptoms. www.anaboliclabs.com 2008 AN ABOLIC L ABORATORIES,LLC All rights reserved. *These statements are for educational purposes and have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Product no. 0154 The supplementation with the longest history is probably the use of β-sitosterol in diets rich in soybean derivatives; typical of southeastern and eastern Asia. Recent experiments with cultured human prostate cancer cells, to elucidate the mechanism of growth inhibition, showed that βsitosterol inhibited cancer cell tumor growth by inducing apoptosis, interrupting prostaglandin biosynthesis and increasing production of reactive oxygen species1. Another study performed on a different human cancer cell line reported a similar result of nicely increased cell apoptosis, here probably by activation of the sphingomyelin (a signal lipid) cycle by β-sitosterol2. Earlier, multicenter studies in Europe, have reported excellent reduction of urinary symptoms and urinary flow where the authors suggested β-sitosterol interacted with hormone receptors of the prostate, though on a much weaker scale, to encourage relief3. A recent review of clinical studies of US tomato consumption, concluded that consumption of whole and cooked tomatoes significantly reduced prostate cancer risk4. Generally, when subjects increased tomato based ingredients in their diets the levels of lycopene and β-carotenes increased in the serum and prostate. Circulating levels of PSA also decreased significantly vs. control groups, pointing to lycopene and perhaps other retinoids as active phytochemicals. Our extract of saw palmetto berries contains many short–chain lipids (e.g. myristic and capric acids) which are effective in non-hormonal, treatment of benign hyperplasia. Clinical studies have shown that regular addition of saw palmetto extract to the diet improved urinary tract symptoms with better urine flow and that improvement continued over a period of many months5. The mechanism for this relief may be the contraction of the volume of the epithelial tissue of the prostate, allowing for more urine volume6. It is thought the actions of saw palmetto extracts are transmitted via some non-hormonal pathway which may explain the lack of reported side effects. The results, after 8 years, from a very large dietary supplementation trial (< 3,600 Canadian men) have pointed to a significant reduction of prostate cancer for those individuals taking selenium, vitamin E and zinc7. For those men beginning the study with normal PSA level, the incidence of cancer was greatly reduced but for those men beginning the study with elevated levels of PSA the cancer incidence was only slightly reduced. The importance of the liberal intake of dietary selenium was accented by another report in the US of a large, long term study of men’s health. When over 1150 men were followed for 13 years, those individuals with the highest selenium intake were least likely to develop prostate cancers8. The authors concluded that even for men diagnosed with high PSA, high dietary selenium slowed the progression of prostate tumors. Low plasma levels of zinc are associated with increased incidence of prostate cancer and moderate zinc supplementation seems to lessen the risk, though the correlation is complicated by highly variable levels of the zinc transporter proteins, hZIP1 and hZIP2 (membrane zinc transporting enzymes), exhibited by individuals9. 1 Awad, A.B., Burr, A.T. and Fink, C.S. (2005). Effect of resveratrol and beta-sitosterol in combination on reactive oxygen species and prostaglandin release by PC-3 cells. Prostaglandins, Leukocytes and Essential Fatty Acids 72(3): 219-226. 2 Von Holtz, R.L., Fink, C.S. and Awad, A.B. (1998). beta-Sitosterol activates the sphingomyelin cycle and induces apoptosis in LNCaP human prostate cancer cells. Nutrition and Cancer 32(1): 8-12. 3 Berges, R.R., Windeler, J., Trampisch, H.J. and Senge T. (1995). Randomized, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet 345: 1529-1532. 4 Campbell, J.K., Canene-Adams, K., Lindshield, B.L., Boileau, T.W.M., Clinton, S.K. and Erdman, J.W. (2004). Tomato phytochemicals and prostate cancer risk. The Journal of Nutrition, Supplement 3486S-3429S. 5 Gerber, G.S., Zagaja, G.P., Bales, G.T., Chodak, G.W. and Contreras, B.A. (1998). Saw palmetto (Serenoa repens) in men with lower urinary tract symptoms: effects on urodynamic parameters and voiding symptoms. Urology 51: 1003-1007. 6 Marks, L., et al., (2000). Effects of a saw palmetto herbal blend in men with symptomatic benign hyperplasia. Journal of Urology 163: 14511456. 7 Meyer, F., Galan, P., Douville, P., Bairato, I., Kegle, P., Bertrais, S., Estaquio, C. and Hercberg, S. (2005). Antioxidant vitamin and mineral supplementation and prostate cancer prevention in the SU.VI.MAX trial. International Journal of Cancer 116: 182-186. 8 Li, H., Stampfer, M.J., Giovannucci, E.L., Morris, J.S., Willett, W.C., Gaziano, J.M. and Ma, J. (2004). A prospective study of plasma selenium levels and prostate cancer risk. Journal of the National Cancer Institute 96: 696-703. 9 Rishi, I., Baidouri, H., Abbasi, J.A., Bullard-Dillard, R., Kajdacsy-Balla, A., Pestaner, J.P., Skacel, M., Tubbs, R. and Bagasra, O. (2003). Prostate cancer in African American men is associated with downregulation of zinc transporters. Applied Immunohistochemistry & Molecular Morphology 11: 253-260. www.anaboliclabs.com 2008 AN ABOLIC L ABORATORIES,LLC All rights reserved. *These statements are for educational purposes and have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Product no. 0154