Decas Botanical Synergies, LLC The Cranberry Ingredient Experts 4 Old Forge Drive Carver, MA 02330 Cranberry Overview VitaFoods Asia 2011 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Presentation Overview A Cranberry Education Decas Overview Cranberry Overview Cranberry UTI – An Effective Dose • • • Proanthocyanidins Latest science Product overview Cranberry for Prostate Health 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Decas Overview Largest and longest operating independent cranberry ingredient company • • • Family owned business with 75 years of history growing, selling and processing cranberries Vertically integrated Secure fruit supply • • 500 acres of Decas fruit Contracts with over 150 independent growers Process over 60 million pounds of raw fruit to deliver • • • • Fresh cranberries – Paradise Meadows retail brand & Private Label Sweetened dried cranberries (SDCs) – Paradise Meadows retail brand, Private Label and industrial ingredients Cranberry juice concentrate – Private Label Cranberry powders and extracts (Decas Botanical Synergies, LLC) – World’s leading source Commitment to science and quality Breadth of intellectual property 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Recent Decas Milestones 2005 – Introduced NutriCran®90S, the world’s first PAC standardized cranberry powder. 2006 – Launched PACran®, the worlds first clinically supported, PAC standardized cranberry powder. 2008 – Spearheaded the development of the de facto industry standard BL DMAC PAC testing method. 2009 – PACran® becomes the first cranberry powder to receive a product specific urinary tract health claim (KFDA). 2010 – DBS secures broad-based patents covering cranberry and other Vaccinium species • U.S. Patents (5,474,774, 5,525,341, 5,646,178, 5,650,432), U.K. Patent (0752871), Australian Patents (703158, 708657) 2010 – DBS published the first clinical evidence linking cranberry (PACran) to prostate health. 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberries Latin Name: Vaccinium macrocarpon Many varieties: (Early Black, Stevens, etc.) Perennial: low-growing, vining, woody Grown in sandy soil Size: 1-2 cm in diameter Weight: 1-2 grams Color: white to black – mostly cranberry red Texture: spongy Taste: all the same, tart Acid profile: citric, quinic, malic (2.2%) pH: 1.8 – 2.3 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Growing Cranberries Grown in Cranberry Bogs Major cranberry production in Wisconsin, Massachusetts, New Jersey, Oregon, Washington, Ontario, Quebec, Vancouver Grown dry, bogs are flooded during harvest 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com The Cranberry Cycle Spring - Bogs and Marshes are drained and blossoms appear for bees to pollinate. Summer - In mid-July the petals fall from the flowers, leaving tiny green nodes that eventually turn into cranberries. Autumn - The harvest season. The fields are flooded for the berries to be harvested. Winter - Bogs and Marshes remain flooded with water that freezes and insulates the vines from frost. Sanded to spur new growth. Source: Cranberry Marketing Committee 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Wet Harvesting Cranberries Most cranberries are wet harvested when growers flood their bogs and use harvesting machines that loosen the cranberries from the vine. With small air pockets in their center, cranberries float to the water’s surface. Growers corral the berries, and then conveyors lift them from the bog onto trucks and then to processing plants. Source: Cranberry Marketing Committee 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry Health Benefits Urinary Tract Health Prostate Health Anti-Diabetes Oral Health Cardiovascular Health Anti-Aging Anti-Cancer Cholesterol Lowering Anti-Inflammatory Bio Preservative Antioxidant 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Urinary Tract Infections The urinary tract above the urethra is bacteriologically sterile Infection arises when E. coli bacteria gain entrance to the urethra • • • Bacteria bind to bladder cells Multiply and deliver toxins Biofilms form in bladder 85-95% caused by E. coli bacteria Infection persists Source: Howell AB, Crit. Rev. Food Sci., 2002 Source: Russo & Johnson, Microbes and Infection, 2003 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Urinary Tract Infections A universal problem • • 60% of women suffer from UTI at least once in a lifetime Affects 11 million woman in the US each year 1/3 of patients reported recurrences within the first year Uncomplicated UTI • 6 -7 days of symptoms • Symptoms are: Frequent and painful urination, lower abdominal pain etc. • Restricted activities and loss of work • US health care cost estimated at > $1 billon Complicated UTI • 30-50% recurrent UTI cases lead to complicated UTI requiring hospitalization and catheterization • US health care cost estimated at > $ 2 billion Source: Brown P et al., Pharmacoeconomics, 2005 Source: Bower JM et al., Traffic, 2005 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com UTIs Treatment & Prevention Treatment: Antibiotics • Gupta et al., J. Am. Med. Assoc. 1999 • • • Ampicillin, sulfamethoxazole, trimethoprim More than 20% E. coli isolates were resistant to ampicillin and sulfamethoxazole Resistance increased from 9% to 18% for trimethoprimsulfamethoxazole from 1992 to 1996 Prevention: Cranberries 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry PACs - UTI Prevention Not urinary acidification • Bodel et. al., 1959 (J. Lab. Clin. Med.) Bacterial anti-adherence • • • • • • Sobota, 1984 (J. Urol.) Schmidet and Sabota 1988 (A.E. Microb.) Ofek et. al., 1991 (NEJM) Avorn, et. al. 1994 (JAMA) Ahuja et al., 1998 (J. Urol.) Foo et. al., 2000 (Phytochemistry) “Bugs Don’t Stick!” 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry Proanthocyanidins (PACs) Proanthocyanidins (PACs) are the key phytochemicals in cranberries Cranberries contain unique A-type PACs A-type PACs are responsible for cranberry’s anti-adhesion properties PACs chemical structure Source: Foo et al., Phytochemistry, 2000 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry PACs Mechanism of Action Bacteria adhere to cell walls with their hair-like fibriae (pili). From Biofilm Infection occurs Cranberry A-type PACs inhibit fimbriae’s adhesion capabilities Bacteria is unable to bind to cell walls. Inhibited bacteria a “flushed” out of the urinary system. Source: Sobota, J. Urol., 1984 Schmidt DR, Sobota, AE Microbios, 1988 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PAC Structures B-linked proanthocyanidin (grape, cocoa) Hydrolyzable tannin (raspberry) A-linked proanthocyanidin (cranberry) Source: Foo et al., Phytochemistry, 2000 Clifford & Scalbert, J. Sci. Food Agri., 2000 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry PACs are Unique Anti-adhesion Activity of Human Urine After Cranberry Juice and Other Drinks (8-ounce servings) Bacterial Anti-adhesion Activity PAC rich products administered Human urine captured at 2, 4, 6 and 8 hours after ingestion Anti-adhesion activity of urine measured Ex vivo Only cranberry subjects exhibit anti-adhesion activity 1.5 1 0.5 0 pre 0-2 2-4 4-6 6-8 Hours After Ingestion Cranberry Juice Cocktail Lipton's Green Tea Welch's Grape Juice Dark Chocolate Mott's Apple Juice Source: Howell, et al., Phytochemistry, 2005 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com DBS PAC-Standardized Cranberry Powders Positive link between cranberry products and health benefits (UTI prevention) The link is proanthocyanidins (PACs) PAC content can vary PAC-standardized powders that can be measured objectively is necessary DBS offers cranberry powders and extracts standardized to different levels of PACs 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PAC Method of Analysis There are many techniques that produce different PACs values for the same sample Methods include: HPLC, European Pharmacopeia, BL-DMAC, Bates Smith, Vanilin, Thiolysis, etc. Since 2005 DBS has used the HPLC method for PAC analysis for a majority of our products Since 2008 the European extract market has dictated that Decas use the European Pharmacopeia method for our PAC-rich extracts Recently the BL DMAC method has become prevalent in the market and is closely linked to the AFFSA health claim DBS can test and the report results of many methods • Always compare PACs using the same method 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry: An Effective Dose 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Cranberry - An Effective Dose Two approaches Rely on Cranberry Juice Cocktail Studies • • • Total Proanthocyandin Content Equivalencies AFFSA health claim Products: Juice Powders and Extracts (NutriCran, CystiCran, Hi-PAC) 36 mg PACs (BL DMAC) Invest Product Specific Human Clinical Evidence • • • Competent and reliable scientific evidence (US structure function claims) KFDA health/functional food claims Products: PACran 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com AFFSA Claim “French Health Claim” based on Total Proanthocyanidin Content of Equivalency AFFSA is the French Food Safety Authority Generic claim, based on Cranberry Juice Cocktail studies and total content of Proanthocyanidins published in 2004 • Generic claim: “Cranberry can help reduce the adhesion of certain E.coli bacteria to the urinary tract walls” Daily dose required for claim: 36 mg of North American (Vaccinium macrocarpon) PACs 36 mg PACs (BL DMAC) PAC Method of analysis BL DMAC The claim is based on the quantity of total BL DMAC PACs in a 300 ml glass of 27% Cranberry, Cranberry Juice Cocktail • A typical glass of cranberry juice cocktail contains 27% single strength cranberry juice 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACran Korean Claim Product Specific claim, based on product specific human clinical evidence PACran’s Claim: “By reducing bacteria adhesion on urinary tract wall, PACran may help to support urinary tract health.” Certificate of Health Functional Food Number 2009-84, approved 2009/11/03 Specific to PACran product line Daily dose required for claim: 500-1,000 mg PACran KFDA Claims: • Process described: “Regulations on health/functional foods in Korea.” Ji Yeon, et. al. Toxicology 221 (2006) 112–118 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com DBS Product Lines Juice Concentrate Powders: NutriCran® family PAC Rich Extracts: Hi-PAC family, CystiCran™ family Clinically Supported Powders: PACran® family 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com NutriCran® Family Cranberry juice concentrate powder PACs: NLT 1% HPLC • ~ 0.8% BL DMAC Solubility: 100% water soluble Nutraceutical application: capsules, tablets, sachets, softgels, etc. World’s first PAC standardized cranberry ingredient (2005) Total PAC Equivalent Dose: ~ 45 grams • Provides 36 mg of BL DMAC PACs 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Hi-PAC Family PAC rich cranberry juice extract powder PACs: NLT 5% BL DMAC Solubility: 99% water soluble Nutraceutical application: capsules, tablets, sachets, softgels, etc. Total PAC Equivalent Dose: 720 mg • Provides 36 mg of BL DMAC PACs 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com CystiCran® / CystiCran 40 Family PAC rich cranberry extract powder PACs: NLT 30% Eur. Ph. or 40% Eur. Ph. • ~10% - 12% BL DMAC Solubility: Soluble with <1% suspended solids Nutraceutical application: capsules, tablets, sachets, softgels, etc. Total PAC Equivalent Dose: ~ 360 mg (CystiCran), ~ 300 mg (CystiCran 40) • Provides 36 mg of BL DMAC PACs 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Pilot Clinical – CystiCran vs. CJC Determine the ex vivo antiadhesion activity in human urine following consumption of two treatments in success with a wash-out period between treatments: • • CystiCran®, 360 mg capsule vs. CJC cranberry extract (36 mg of DMAC PAC / serving) No statistically significant differences between treatments. ‐ September 23, 2009 Bacterial Anti adhesion Activity of Human Urine: PACran Capsule vs. Theracran Capsule Consumption Amy Howell, Ph.D., Associate Research Scientist, Rutgers University 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PAC Comparison Product BL DMAC PACs HPLC PACs Eur. Ph. PACs Efficacious Dose NutriCran®90 Family ~0.8% NLT 1.0% ~5.0% 3-5 grams Hi-PAC Family NLT 5.0% NLT 4.0% NLT 10% 720 mg CystiCran Family NLT 13% ~10-12% ~18% NLT 30 or 40% 300-450 mg PACran ~0.6% NLT 1.5% ~8.0% 500 mg (clinical) “~” Denotes the typical value, otherwise data is from the product specification 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACran® All Natural Whole Berry Powder First Cranberry Product with a Health Claim Most Cost Effective Efficacious Dose Available One Pill A Day - Compliance Clinical Support For Urinary Tract Health Standardized Formula Superior Anti-Adhesion Activity Patented Formulation and Actives Loaded with Bio-Active Proanthocyanidins Clinical Support for Prostate Health 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Product Specific Clinical Support The PACran Approach A daily dose of 500 mg of PACran has been: • • • • Clinically shown to support urinary tract health Clinically shown to reduce E. coli Shown to exhibit the anti adhesion equivalent of a glass of Cranberry Juice Cocktail Shown to exhibits the anti adhesion equivalent of a 36 mg PAC cranberry supplement Awarded a Government Sanctioned Health Claim by the Korean Food and Drug Administration: • “By reducing bacteria adhesion on urinary tract wall, PACran® may help to support urinary tract health.” 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACran – An Efficacious Dose Developed from the ground up to deliver an efficacious dose of Cranberry to support Urinary Tract Health: Good Agricultural Practices • Vertically Integrated Consistency of Botanical Materials • Naturally superior, Phytochemical analysis Product Design and Formulation • Standardized, Reproducible, 100% Cranberry Manufacturing Processes • Vertically integrate, SOP, QA Method of Analysis • Commercially available, independent validation Safety • AOT, Safety studies Efficacy • Clinical publication, Ex vivo/In vitro work and publication, bio assay Health Claim • KFDA 2009-84 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACran Formulation Proprietary blend of whole fruit • • • • Skins Seeds Flesh Fresh fruit juice 100% Cranberry – whole fruit synergies • • • • • • PACs Phenolics Organic Acids Fiber Protein Etc. 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Superior Raw Materials PAC content varies depending on cranberry Mean Fruit Proanthocyanidin Levels variety 12 Smaller fruit typically yields 10 higher PAC content 8 Decas allocates fruit PACs according to PAC content (mg/g) 6 4 Ben Lear Cropper Crowley Early Black Franklin Howes Pilgrim Number 35 2 Stevens Wilcox 0 Variety Source: et Drive, al., American 4 OldVorsa Forge Carver,Chemical MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 Society, Chapter 26, p 298, 2003 email: [email protected] www.decasbotanical.com Safety Study – JAFC “Long-Term Effects of Three Commercial Cranberry Products on the Antioxidative Status in Rats: A Pilot Study” • J. Agric. Food Chemistry No adverse effects reported Hemetological parameters, body weight, food consumption unaffected 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Ex Vivo PACran Research Pilot Clinical Evidence: • “Bacterial Anti-adhesion Activity of Human Urine Following 27% Cranberry Juice Cocktail vs. PACran Capsule Consumption” • • • Presented at ACS 2009 Annual Meeting Amy Howell, Ph.D., Associate Research Scientist, Rutgers University, February 24, 2009, “Bacterial Anti‐adhesion Activity of Human Urine: PACran Capsule vs. Theracran Capsule Consumption” • Amy Howell, Ph.D., Associate Research Scientist, Rutgers University, September 23, 2009 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Rutgers Ex Vivo Pilot Clinical Design Determine the Ex vivo antiadhesion activity in human urine following consumption of two treatments in succession with a wash-out period between treatments: • • • • • Subjects intake 500 mg of PACran Urine sampling and analysis intervals Washout period Subjects intake recommended dose of comparison product Urine sampling and analysis intervals 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Rutgers: PACran vs. CJCocktail Results Bacterial Anti-adhesion Activity of Human Urine Following 27% Cranberry Juice Cocktail vs. PACran Capsule Consumption PACran®: • • 500 mg capsule 4 mg BL DMAC PACs Cranberry Juice Cocktail • • 10 ounce serving Cranberry content of 27% 38 mg of DMAC PAC Discussion: • • No statistically significant differences in anti-adhesion between treatments PACran contains Prevention PACs that exhibit superior anti-adhesion at 24 hr. vs. CJC 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Rutgers: PACran vs. TheraCran Results Bacterial Anti‐adhesion Activity of Human Urine: PACran Capsule vs. TheraCran Capsule Consumption PACran®: • • 500 mg capsule 4 mg BL DMAC PACs Cranberry Juice Cocktail • • 1,300 mg (2 x 650 mg capsules) 34 mg of DMAC PAC Discussion: • • No statistically significant differences in anti-adhesion between treatments PACran contains Prevention PACs that exhibit superior anti-adhesion at 24 hr. vs. TheraCran 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PAC Polymerization PACs are not a single molecule • Catechin/epicatechin groups linked together via ‘A’ and/or ‘B’ bonds trimer dimer PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin 5mer PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin 6mer PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin 7mer PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin 8mer PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin 9mer PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin No bioavailability studies have been conducted, but it has been proposed that lower molecular weight, monomers, dimmers, trimers are more readily absorbed/metabolized 10mer PAC Catechin tetramer Mechanism for absorption and metabolism of PACs in the body is unknown • monomer 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACs Absorption 10mer PAC 1. PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin PAC Catechin Cell Lining LMW PACs cannot be absorbed Cell lining Cell lining 2. Enzymes Enzymes Cell lining PAC Catechin PAC Enzymes PAC Catechin Catechin Cell lining PAC Enzymes PAC Catechin Catechin Cell lining PAC Enzymes PAC Catechin Catechin Cell lining PAC Enzymes PAC Catechin Catechin PAC Catechin 10mer are broken down into smaller catechin groups by enzymes in the gastro-intestinal tract Cell lining 3. Cell lining PACEnzymesPAC Catechin Catechin Enzymes Enzymes Cell lining Cell lining Enzymes Enzymes Cell lining Cell lining Enzymes PAC Catechin PAC Catechin Enzymes Smaller molecular weight PACs are absorbed by the body Cell lining PAC Catechin PAC Catechin Cell lining PAC Catechin PAC Catechin Cell lining PAC Catechin PAC Catechin Cell lining 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PAC Polymerization by Product Sample ID / Brunswick Lab ID 1mers 2mers 3mers 4mers 5mers 6mers 7mers 8mers 9mers 10mers >10mer total mg/g % >10mer PACran Lot#060131 0.17 0.76 0.35 0.19 0.12 0.13 0.03 0.07 0.13 0.18 22.08 24.21 91% NutriCran 90 lot# 60116 0.57 1.23 0.39 0.18 0.07 0.11 0.03 0.06 0.15 0.15 2.28 5.22 44% Cranberry Juice Concentrate 14 32 9 9 7 5 4 3 2 0 88 173 51% Percent PAC Polymerization 100% 80% PACran 60% NutriCran®90 40% Cranberry Juice Cocktail 20% 9m e 10 r s m e >1 rs 0m er er s 8m er s 7m er s 6m er s 5m er s 4m er s 3m er s 2m 1m er s 0% 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PAC Quality vs. Quantity Independent HPLC PAC analysis has consistently shown that PACran contains at least 80% Large Molecular Weight PACs (LMW PACs) while Juice powders and CJC contain approximately 50% LMW PACs • Large Molecular Weight PACs are defined as greater than 10 catechin groups. PACran contains ~ 10% monomers, dimers, and trimers while Cranberry Juice powders and CJC contain approximately 35% monomers, dimers, and trimers LMW PACs are not readily absorbed in the body rather they must be broken down into smaller catechin groups (monomers, dimers, trimers, etc.) in order to be absorbed Ex Vivo work at Rutgers shows that PACran has significant Ex Vivo bacterial anti adhesion • Statistically similar Ex vivo anti adhesion to products that contain 8-10X the total PAC content Clinical work shows that PACran helps reduces E. coli and reduced UTI recurrence rates 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Clinical Research & Substantiation Product Specific Human Clinical Evidence • “A randomized, double blind, controlled, dose dependent clinical trial to evaluate the efficacy of a proanthocyanidin standardized whole cranberry (Vaccinium macrocarpon) powder on infections of the urinary tract.” • • Published in Current Bioactive Compounds, April 2011 “A randomized double blind placebo conrolled trial to evaluate the efficacy of cranberry powder as a prophylactic against recurrent urinary tract infection in women” • • • Completed April 2011 Scheduled to be presented at PHYTOPHARM 2011 conference in Nuremburg in Germany, July 25-27, 2011. To be submitted for publication 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com CBC Clinical Design “A randomized, double blind, controlled, dose dependent clinical trial to evaluate the efficacy of a proanthocyanidin standardized whole cranberry (Vaccinium macrocarpon) powder on infections of the urinary tract.” Current Bioactive Compounds, April 2011 Randomized, double blind, controlled study 57 women aged 18-40 years, all culture positive with UTI symptoms Randomly distributed into 3 groups • • • Group 1 (control) Group 2 (low dose 500 mg/day) Group 3 (high dose 1,000 mg/day) 90 day duration Evaluations at: Baseline (Day 0), Day 10, Day 30, Day 60, Day 90 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com CBC Clinical Results PACran® reduces E. coli load and improves UTI symptoms after only 10 days After 90 days, there was a 36% E. coli reduction in the 500 mg PACran group After 90 days, there was a 65% E. coli reduction in the 1,000 mg PACran group The two treatment groups (500 mg and 1,000 mg) were significantly different from the control group for the bacterial load CBC, Page 44 CBC Page 45 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PHYTOPHARM Clinical Design “A randomized double blind placebo controlled trial to evaluate the efficacy of cranberry powder as a prophylactic against recurrent urinary tract infection in women” Scheduled to be presented at PHYTOPHARM 2011 conference in Nuremburg in Germany, July 25-27, 2011. To be submitted for publication. Randomized, Double Blind, Placebo Controlled study 165 women aged 18-60 years, all with at least 1 UTI within the last 12 months Randomly distributed into 2 groups • • Placebo control 500 mg PACran 180 day duration Evaluations at: Baseline (Day 0) and Day 180 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PHYTOPHARM Clinical Results Recurrence events: • • Placebo Group: 22 PACran Group: 11 Recurrence rate • • Placebo Group: 25.7% (95% confidence interval, 15.9% 34.5%) - corresponds to an assumed 30% recurrence rate in the placebo group PACran Group: 14.2% (95% confidence interval, 6.0% 21.7%) - corresponds to an absolute reduction in UTI recurrence of 15%. 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Efficacious Dose by Product Product Dose Price/Dose Claims PACran 500 mg $0.045 Clinically Substantiated: Clinically shown/proven to support urinary tract health Clinically shown to reduce E. coli Anti adhesion equivalent of a glass of Cranberry Juice Cocktail Anti adhesion equivalent of a 36 mg PAC cranberry supplement Government Sanctioned: “By reducing bacteria adhesion on urinary tract wall, PACran® may help to support urinary tract health.” - KFDA Cranberry Juice Concentrate Powder (NutriCran®90 Family) 3-5 g $0.165 - $0.275 European based equivalency only: Cranberry Extract (CystiCran Family) 300 mg Cranberry Juice Extract Powder (Hi-PAC Family) 720 mg “Cranberry can help reduce the adhesion of certain E.coli bacteria to the urinary tract walls” $0.12 European based equivalency only: “Cranberry can help reduce the adhesion of certain E.coli bacteria to the urinary tract walls” $0.11 European based equivalency only: “Cranberry can help reduce the adhesion of certain E.coli bacteria to the urinary tract walls” 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com The PACran® Approach Built from the ground up for Urinary Tract Health • • • • Strong library of competent and reliable scientific evidence The most cost effective clinically efficacious dose of cranberry in the world Standardized formulation Clinical support • • • Urinary Tract Health Prostate Health KFDA Health Claim 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACran Beyond UTI 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com PACran® Human Clinical – Prostate Health The first and only human clinical to evaluate cranberry in the treatment of Lower Urinary Tract Symptoms (LUTS) / BPH Title: “The effectiveness of dried cranberries in men with lower urinary tract symptoms” Authors: Ales Vidlar, Jitka Vostalova, Jika Ulrichova, Vladimir Student, David Stejskal, Richard Reichenbach, Jana Vrbkova, Filip Ruzicka, Vilim Simanek Publication: British Journal of Nutrition, accepted for publication Product: PACran®, 100% cranberry powder Conclusion: PACran® may help to improve prostate health in men with LUTS 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Clinical Study Design Randomized, controlled study 42 participants at risk of prostate disease with LUTS, elevated PSA, negative prostate biopsy, clinically confirmed chronic nonbacterial prostatitis • • Treatment (n=21) 1,500 mg/day PACran®. One 500 mg capsule, three times daily Control (n=21) 180 day duration Evaluation criteria: IPSS, QoL, Prostate volume, Urinary flow rate, Residual urine volume, PSATOT level measured at baseline, 90 days and 180 days. 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Clinical Results Effect of PACran on IPSS • 44% Improvement vs. control Effect of PACran on QoL • 50% Improvement vs. control Effect of PACran on Qmax (Maximal Urinary Flow Rate) • 25% Improvement vs. control Effect of PACran on, Qave (Average Urinary Flow Rate) • 20% Improvement vs. control Effect of PACran on, V (Prostate Bladder Voiding) • 10% Improvement vs. control Effect of PACran on, RV (Postvoid Residual Urine) • 65%. Improvement vs. control Effect of PACran on, PSA (Prostate-Specific Antigen) • • • PSA reduced by 32% in PACran group vs. control PSA levels decreased in 80% of patients The ratio of free to total PSA (PSAfree/PAStot) increased 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Unique Benefits of PACran® for Prostate PSA reduced by 32% • • Ratio of PSAfree to PSAtotal decreased Testosterone levels remain unchanged • • Coupled with decrease in PSA intimates that there was no TST to DHT conversion Increased levels of DHT are related to prostate enlargement/cancer People suffering from BPH have an increased tendency to experience Urinary Tract Infections (UTIs). • PACran has been clinically shown to support urinary tract health (UTI prophylactic) Natural prophylactic no antibiotic resistance • PACran’s ability to decrease PSA levels demonstrates it may be as effective as antibiotic treatment but without the risk of antimicrobial resistance and a minimum of adverse effects (ED, etc) 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com DBS Contacts Dan Souza Director of Sales and Marketing [email protected] Mobile: 774 313 6298 Offcie: 774-435-0109 Fax: 774-435-0209 Chris Hoover Account Manager [email protected] Mobile: (435)740-4417 Office: (435)772-9393 Fax: (435)772-9390 http://www.decasbotanical.com 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com Visit us at Booth 351 4 Old Forge Drive, Carver, MA 02330 Tel: 508.866.8506 Fax: 508.866.9020 email: [email protected] www.decasbotanical.com
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