NUTRA Prostate Description As men age, they experience hormonal changes that can affect prostate and urinary tract health. Specially formulated to support prostate health, NUTRA Prostate contains herbal extracts that may lessen inflammation and restore healthy hormone levels: Pygeum, Saw Palmetto, Stinging Nettle, Lyc-O-Mato®, and Graminex™ flower pollen. This nutritional combination makes NUTRA Prostate a comprehensive source of essential amino acids, carotenoids, vitamins, and minerals that are valuable to prostate and urinary tract health. Overview NUTRA Prostate combines high-quality ingredients from the United States, Europe, and Israel to offer nutritional support for prostate health. This beneficial combination includes four natural, botanical extracts, Pygeum, Saw Palmetto, Nettle, and Lycopene, along with Graminex™ flower pollen. In addition, NUTRA Prostate includes zinc and selenium that are essential to hormonal health. Research Graminex™ Graminex™ flower pollen is exclusively manufactured in the United States and contains various micro-nutrients that are important to prostate health. A twelve-week study recruited 79 patients with excessive cell proliferation in the prostate to take pollen extract finding the extract aided healthy prostate and urination function.1 Similarly, sixty patients with an enlarged prostate that took pollen extract for six months reported an improvement in urination flow.2 One study reviewed the effects of pollen extract on abnormal prostate cells finding excessive cellular growth was inhibited by the extract.3 Another study found that pollen extract reduced prostate inflammation and improved sperm motility, as the extract inhibited free radical proliferation.4 Lycopene (Lyc-o-mato®) Lyc-O-Mato® is a unique lycopene formula that offers superior-bioavailability of antioxidants and phytonutrients, including tomato carotenoids to support prostate health. Researchers have suggested lycopene shows promising results in maintaining prostate health in several in vitro, animal, and clinical trials.5,6,7 A meta-analysis of lycopene’s benefits on prostate health found that greater lycopene intake was 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com associated with healthy prostate function.8 A case-control study reviewed the relationship between antioxidant serum levels and normal prostate function among healthy men. After thirteen years, a follow-up included 578 men that had developed prostate ailments. Results indicated that low lycopene levels had a significant association with the development of abnormal prostate function.9 Pygeum As a native evergreen tree that grows in South Africa, Pygeum africanum extract contains active constituents, including phytosterols (β-sitosterol, β-sitosteryl glucoside, and β-sitosterone) that benefit prostate health. Pygeum has been shown to inhibit the growth of abnormal cells and proteins related to an inflamed prostate.10 Due to the significant increase of the annual harvest in the last decade trade in its bark has been added to Appendix II of the Convention Trade in Endangered Species (CITES). NUTRA Prostate utilizes Pygeum that conforms to the CITES. An enlarged prostate effects urinary tract function.14 A meta-analysis reviewed studies on Pygeum and prostate health from 1966 to 2000. The review found that men taking Pygeum were twice as likely to report a reduction in symptoms related to an enlarged prostate, such as obstructed urinary tract function.11 A two-month treatment with Pygeum extract showed improvement in urinary flow among men (50-75 years old) with enlarged prostate symptoms.12 Another study compared the dosage of Pygeum extract, 50 mg/twice daily to 100 mg/once daily, among 209 patients with prostate inflammation. Results indicated both doses of Pygeum extract were equally effective and safe for supplementation.13 One study reviewed androgen receptor activity that is associated with prostate growth. Results indicated Pygeum was effective in inhibiting excessive androgen activity.14 An in vitro study observed the effects of Pygeum on human prostate cells finding the extract inhibited the proliferation of abnormal cells.15 Saw Palmetto Saw Palmetto extract comes from Saw Palmetto plants that are native to the United States. This potent herb is effective in deterring dihydrotestosterone, a compound that causes abnormal cell proliferation.16 Saw Palmetto is comparable to traditional prostate treatments and is well-tolerated among individuals with prostate ailments.17 A randomized trial recruited 92 men with urinary tract ailments related to prostate growth to take Saw Palmetto or a placebo, concluding Saw Palmetto may have shortterm effects in improving urinary function.18 Similarly, a six-month treatment recruited 85 men with prostate ailments to take Saw Palmetto or a placebo finding the herb improved urinary tract function.19 One study observed the effects of Saw Palmetto and Cernitin (pollen extract) on mice with abnormal prostate growth. Results indicated both natural compounds suppressed prostate growth by affecting androgen metabolism.20 Furthermore, Saw 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com Palmetto reduced abnormal cellular growth by decreasing Cox-2 expression that is associated with prostate inflammation.21 Selenium Selenium is predominately found in the tissue of the prostate gland and low selenium levels may be related to abnormal prostate function. One study found selenium supplementation was beneficial to prostate health, as selenium circulates through the prostate to aid normal cellular production.22 Another study measured serum selenium in 212 men with abnormal cell function in the prostate and 233 men with normal prostate health. Low serum levels were related to prostate ailments concluding selenium may reduce the risk of abnormal cell growth.23 A research trial examined the effects of selenium (200 mcg/day) on various risks related to cellular dysfunction finding selenium significantly protected normal cellular function in the prostate gland.24 Stinging Nettle A medicinal plant found in various regions, Stinging Nettle has anti-inflammatory properties that benefit prostate health and improve urinary flow. A six-month study found that Stinging Nettle improved urinary tract function in 232 patients with inflamed prostate and urinary flow obstruction.25 Similarly, a 96-week study included 219 subjects with urinary tract ailments to take a Stinging Nettle/sabal fruit combination or a placebo. Results indicated that urinary flow improved among subjects taking the Stinging Nettle formulation.26 One study observed the effects of Stinging Nettle on prostate tissue in patients with prostate ailments. Results indicated Stinging Nettle significantly inhibited enzymatic activity that leads to excessive cellular growth.27 Researchers have also found that the proliferation of abnormal prostate cells was deterred by Stinging Nettle after seven days of treatment.28 An animal study found Stinging Nettle reduced an enlarged prostate by 33.8% in mice.29 The same researchers extended their study to human prostate cells finding Stinging Nettle inhibited the excessive proliferation of prostate cells.30 Zinc Zinc is an essential trace element that is crucial to various body functions, including prostate health. The prostate needs high levels of zinc to maintain DNA integrity and regulate cellular growth.31 One study found that zinc deficiency increases DNA damage and leads to abnormal cell growth.32 Another study observed zinc activity in prostate cells, finding it is a main component of regulating cell growth to prevent abnormal prostate growth.1 A longitudinal study examined the relationship between zinc concentrations and prostate health among 2,901 men that developed abnormal prostate growth over a 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com period of 14 years. Results indicated that up to 100 mg/day of zinc supplementation supported prostate health. In contrast, individuals that took doses higher than 100 mg/day of zinc were more likely to develop abnormal cell growth in the prostate gland.33 Additional Information – Dosage & Interactions Suggested Use: As a dietary supplement, take one capsule twice daily, or as directed by a physician. Dosage: Graminex™ - Up to 360 mg per day in divided doses Lycopene (Lyc-o-mato®) - Up to 30 mg per day (actual Lycopene) Pygeum – Up to 200 mg per day in divided doses Saw Palmetto – Up to 1,000 mg per day Selenium – Up to 900 mcg per day Stinging Nettle – Up to 240 mg in divided doses Zinc – Up to 30 mg per day 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com Precautions: The maximum safe dosages of the nutrients in this formula have not been determined for men with severe liver or kidney disease. As with all supplement regimens, please consult your physician prior to use. Graminex™ – There are no known adverse reactions with proper supplementation. Lycopene (Lyc-o-mato®) - There are no known adverse reactions with proper supplementation. Pygeum – May cause mild stomach upset. Saw Palmetto – Individuals with hormone cancers (breast, prostate, etc.) should not take Saw Palmetto. Selenium - Pregnant women and nursing mothers should avoid taking doses greater than the RDA amount of selenium (60 to 70 mcg/day). Excessively high doses of selenium can lead to dry hair, brittle nails, fatigue, irritability, nausea, and vomiting. Stinging Nettle – Stomach upset has been reported in higher doses. Zinc – High doses of zinc can lead to copper deficiency or cause stomach upset. Drug Interactions: Consult a physician before taking NUTRA Prostate if you are taking the following medications, as they may interact with key nutrients. GraminexTM – There are no known interactions with proper supplementation. Lycopene (Lyc-o-mato®) supplementation. - There are no known interactions with proper Pygeum – There are no known interactions with proper supplementation. Saw Palmetto – Coumadin, Hormone Drugs (block Saw Palmetto efficacy) Selenium – There are no known interactions with proper supplementation. Stinging Nettle – Tannin found in Stinging Nettle may affect iron absorption. Separate administration by one to two hours to avoid this interaction. Zinc – Antibiotics block zinc absorption. *Statements made herein have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com any disease. 1 Yasumoto R, Kawanishi H, Tsujino T, et al. Clinical evaluation of long-term treatment using cernitin pollen extract in patients with benign prostatic hyperplasia. Clin Ther. 1995 Jan-Feb; 17(1):82-87. 2 Buck AC, Cox R, Rees RW, et al. Treatment of outflow tract obstruction due to benign prostatic hyperplasia with the pollen extract cernilton. A double-blind, placebo-controlled study. Br J Urol. 1990 Oct; 66(4):398-404. 3 Habib FK, Ross M, Buck AC, et al. In vitro evaluation of the pollen extract, cernitin T-60, in the regulation of prostate cell growth. Br J Urol. 1990 Oct; 66(4):393-397. 4 Cheng HJ, et al. Effects of pollen extract EA-10, P5 on chronic prostatitis or infertility with chronic prostatitis. Act Pharmacol Sin. 2002 Nov; 23(11):1035-1039. 5 Dahan K, Fennal M, Kumar NB. Lycopene in the prevention of prostate cancer. J Soc Integr Oncol. 2008 Winter; 6(1):29-36. 6 Fraser ML, Lee AH, Binns CW. Lycopene and prostate cancer: emerging evidence. Expert Rev Anticancer Ther. 2005 Oct; 5(5):847-854. 7 Miller EC, Giovannucci E, Erdman JW Jr, et al. Tomato products, lycopene, and prostate cancer risk. Urol Clin North Am. 2002 Feb; 29(1):83-93. 8 Giovannucci E, Rimm EB, Liu Y, et al. A prospective study of tomato products, lycopene, and prostate cancer risk. J Natl Cancer Inst. 2002 Mar 6; 94(5):391-398. 9 Gann PH, Ma J, Giovannucci E, et al. Lower prostate cancer risk in men with elevated plasma lycopene levels: results of a prospective analysis. Cancer Res. 1999 Mar 15; 59(6):1225-1230. 10 Shenouda NS, Sakla MS, Newton LG, et al. Phytosterol Pygeum africanum regulates prostate cancer in vitro and in vivo. Endocrine. 2007 Feb; 31(1):72-81. 11 Wilt T, Ishani A, Mac Donald R, et al. Pygeum africanum for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2002; (1):CD001044. 12 Breza J, Dzurny O, Borowka A, et al. Efficacy and acceptability of tadenan (Pygeum africanum extract) in the treatment of benign prostatic hyperplasia (BPH): a multicentre trial in central Europe. Curr Med Res Opin. 1998; 14(3):127-139. 13 Chatelain C, Autet W, Brackman F. Comparison of once and twice daily dosage forms of Pygeum africanum extract in patients with benign prostatic hyperplasia: a randomized, double-blind study, with long-term open label extension. Urology. 1999 Sep; 54(3):473-478. 14 Schleich S, Papaioannou M, Baniahmad A, Matusch R. Extracts from Pygeum africanum and other ethnobotanical species with antiandrogenic activity. Planta Med. 2006 Jul; 72(9):807813. 15 Santa María Margalef A, Paciucci Barzanti R, Reventós Puigjaner J, et al. Antimitogenic effect of Pygeum africanum extracts on human prostatic cancer cell lines and explants from benign prostatic hyperplasia. Arch Esp Urol. 2003 May; 56(4):369-378. 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com 16 Wadsworth TL, Worstell TR, Greenberg NM, Roselli CE. Effects of dietary Saw Palmetto on the prostate of transgenic adenocarcinoma of the mouse prostate model. Prostate. 2007 May 1; 67(6):661-673. 17 Gordon AE, Shaughnessy AF. Saw Palmetto for prostate disorders. Am Fam Physician. 2003 Mar 15; 67(6):1281-1283. 18 Shi R, Xie Q, Gang X, et al. Effect of Saw Palmetto soft gel capsule on lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized trial in Shanghai, China. J Urol. 2008 Feb; 179(2):610-615. 19 Gerber GS, Kuznetsov D, Johnson BC, Burstein JD. Randomized, double-blind, placebocontrolled trial of Saw Palmetto in men with lower urinary tract symptoms. Urology. 2001 Dec; 58(6):960-964; discussion 964-965. 20 Talpur N, Echard B, Bagchi D, et al. Comparison of Saw Palmetto (extract and whole berry) and Cernitin on prostate growth in rats. Mol Cell Biochem. 2003 Aug; 250(1-2):21-26. 21 Goldmann WH, Sharma AL, Currier SJ, et al. Saw Palmetto berry extract inhibits cell growth and Cox-2 expression in prostatic cancer cells. Cell Biol Int. 2001; 25(11):1117-1124. 22 Sabichi AL, Lee JJ, Taylor RJ, et al. Selenium accumulation in prostate tissue during a randomized, controlled short-term trial of l-selenomethionine: a Southwest Oncology Group Study. Clin Cancer Res. 2006 Apr; 12(7):2178-2184. 23 Vogt TM, Ziegler RG, Graubard BI, et al. Serum selenium and risk of prostate cancer in U.S. blacks and whites. Int J Cancer. 2003 Feb; 103(5):664-670. 24 Duffield-Lillico AJ, Dalkin BL, Reid ME, et al. Selenium supplementation, baseline plasma selenium status and incidence of prostate cancer: an analysis of the complete treatment period of the Nutritional Prevention of Cancer Trial. BJU Int. 2003 May; 91(7):608-612. 25 Safarinejad MR. Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study. J Herb Pharmacother. 2005; 5(4):1-11. 26 Lopatkin N, Sivkov A, Schläfke S, et al. Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms--long-term follow-up of a placebo-controlled, double-blind, multicenter trial. Int Urol Nephrol. 2007; 39(4):1137-1146. 27 Durak I, Biri H, Devrim E, et al. Aqueous extract of Urtica dioica makes significant inhibition on adenosine deaminase activity in prostate tissue from patients with prostate cancer. Cancer Biol Ther. 2004 Sep; 3(9):855-857. 28 Konrad L, Müller HH, Lenz C, et al. Antiproliferative effect on human prostate cancer cells by a Stinging Nettle root (Urtica dioica) extract. Planta Med. 2000 Feb; 66(1):44-47. 29 Lichius JJ, Renneberg H, Blaschek W, et al. The inhibiting effects of components of Stinging Nettle roots on experimentally induced prostatic hyperplasia in mice. Planta Med. 1999 Oct; 65(7):666-668. 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com 30 Lichius JJ, Lenz C, Lindemann P, et al. Antiproliferative effect of a polysaccharide fraction of a 20% methanolic extract of stinging nettle roots upon epithelial cells of the human prostate (LNCaP). Pharmazie. 1999 Oct; 54(10):768-771. 31 Dubi N, Gheber L, Fishman D, et al. Extracellular zinc and zinc-citrate, acting through a putative zinc sensing receptor, regulate growth and survival of prostate cancer cells. Carcinogenesis. 2008 Feb 28. 32 Yan M, Song Y, Wong CP, et al. Zinc deficiency alters DNA damage response genes in normal human prostate epithelial cells. J Nutr. 2008 Apr; 138(4):667-673. 33 Leitzmann MF, Stampfer MJ, Wu K, et al. Zinc supplement use and risk of prostate cancer. J Natl Cancer Inst. 2003 Jul 2; 95(13):1004-1007. 669 West 900 North • North Salt Lake, Utah 84054 801-294-1400 • fax: 801-294-1401 • www.nutrascriptives.com
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