Cranberry Overview VitaFoods Asia 2011 Decas Botanical Synergies, LLC The Cranberry Ingredient Experts

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
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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
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Family owned business with 75 years of history growing, selling and
processing cranberries
Vertically integrated
Secure fruit supply
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500 acres of Decas fruit
Contracts with over 150 independent growers
Process over 60 million pounds of raw fruit to deliver
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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
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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
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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
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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
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Gupta et al., J. Am. Med. Assoc. 1999
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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
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Bodel et. al., 1959 (J. Lab. Clin. Med.)
Bacterial anti-adherence
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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
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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]
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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
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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
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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
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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
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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:
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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
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~ 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
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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
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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.
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~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)
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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:
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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
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email: [email protected]
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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:
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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:
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“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
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Vertically Integrated
Consistency of Botanical Materials
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Naturally superior, Phytochemical analysis
Product Design and Formulation
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Standardized, Reproducible, 100% Cranberry
Manufacturing Processes
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Vertically integrate, SOP, QA
Method of Analysis
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Commercially available, independent validation
Safety
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AOT, Safety studies
Efficacy
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Clinical publication, Ex vivo/In vitro work and publication, bio assay
Health Claim
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KFDA 2009-84
4 Old Forge Drive, Carver, MA 02330
Tel: 508.866.8506
Fax: 508.866.9020
email: [email protected]
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PACran Formulation
Proprietary blend of whole fruit
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Skins
Seeds
Flesh
Fresh fruit juice
100% Cranberry – whole fruit
synergies
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PACs
Phenolics
Organic Acids
Fiber
Protein
Etc.
4 Old Forge Drive, Carver, MA 02330
Tel: 508.866.8506
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email: [email protected]
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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”
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J. Agric. Food Chemistry
No adverse effects reported
Hemetological parameters, body
weight, food consumption
unaffected
4 Old Forge Drive, Carver, MA 02330
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email: [email protected]
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Ex Vivo PACran Research
Pilot Clinical Evidence:
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“Bacterial Anti-adhesion Activity of Human Urine Following 27%
Cranberry Juice Cocktail vs. PACran Capsule Consumption”
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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:
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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]
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Rutgers: PACran vs. CJCocktail Results
Bacterial Anti-adhesion Activity of
Human Urine Following 27%
Cranberry Juice Cocktail vs. PACran
Capsule Consumption
PACran®:
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500 mg capsule
4 mg BL DMAC PACs
Cranberry Juice Cocktail
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10 ounce serving Cranberry content
of 27%
38 mg of DMAC PAC
Discussion:
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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
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Rutgers: PACran vs. TheraCran Results
Bacterial Anti‐adhesion Activity of
Human Urine: PACran Capsule vs.
TheraCran Capsule Consumption
PACran®:
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500 mg capsule
4 mg BL DMAC PACs
Cranberry Juice Cocktail
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1,300 mg (2 x 650 mg capsules)
34 mg of DMAC PAC
Discussion:
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No statistically significant
differences in anti-adhesion
between treatments
PACran contains Prevention PACs
that exhibit superior anti-adhesion
at 24 hr. vs. TheraCran
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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
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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
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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%
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email: [email protected]
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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
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email: [email protected]
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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
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email: [email protected]
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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
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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
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email: [email protected]
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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
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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
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Fax: 508.866.9020
email: [email protected]
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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
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Fax: 508.866.9020
email: [email protected]
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PACran Beyond UTI
4 Old Forge Drive, Carver, MA 02330
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email: [email protected]
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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
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email: [email protected]
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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.
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email: [email protected]
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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
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email: [email protected]
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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