evesse® “... its why fruit is good for you!” richard wood chief executive coressence limited...

Evesse®“... Its why fruit is good for you!”

Richard WoodChief Executive

Coressence LimitedEmail: [email protected]

© Coressence 2007© Coressence 2007

Health Claim CriteriaCharacterised food componentFood matrix and dietary contextEpidemiology based evidence

Data management / search / inclusion / exclusion criteriaSubstantiation based on human intervention studies

Bio-active amount required and frequency of consumptionValidated bio-markers and/or true end pointsTotality of available data


Characterised food componentEvesse® Apples are flavanol-richEvesse® contains the same flavanols as cocoa and grapesEvesse® blends with fruit juices, waters and low-fat yogurtsEvesse® health claims relate to the “...maintenance of a

healthy circulation...”


The Evesse® Apple• Grown in the UK• Non-Organic• Organic

3 Products:• Blending Juice• Fructose Syrup• Natural Red colour


True dietary context of apples in the UK Circa 80% of dietary fruit intake!

Food Matrix & Dietary Context Flavanol consumption from fruits – largest categoryWomen consume more than men – 5 to 25% more!


mean =290 mg/d “consumers”

Max >1000 mg/d “consumers”

Women

Men

Range 300 to 1000 mg/p/d

Source: Coressence analysis of UK NDNS data combined with US DA Flavanol database 2007

Food Matrix Model

Source: Coressence analysis of NDNS data 2004


Note: 1) 81% of potential consumers could consume 505 g/day of foods containing Evesse2)Maximum mean daily consumption of active flavanols = 150 mg/day 3)50% of UK mean consumption or 13% of UK maximum consumption

Food Matrix Model


Note: Food intake model assumes Evesse is added at bio-active amount to each group

Antioxidant Measures In-vitro tests for antioxidants don’t account for:

Bioavailability i.e. The affect of absorption into the circulation.

High degree of polymerisation = low bioavailability but High ORAC value!

Metabolites i.e. The metabolites in circulation are not those

tested by the assay! High ORAC values can have Low bioavailability Low ORAC values can have High bioavailability


Note: Applies ORAC,TAC, TRAP and FRAP assays

Health Claims

Article 13.1 Claims

Based on generally

accepted science

Article 13.5 Claims

Based on newly developed

science with IPR protection

Article 14 Claims

Disease Risk Reduction and/or

child development &

health

Scientific substantiation Article 6


Online Search – Maintained Records

Online search of PubMed

Online Search on “key words”

Total number of Peer Reviewed Publications

38,285!


Note: Based on EndNote X1 software

Peer-reviewed Publications


Nobel Prize

Epidemiology – is usefulMeta Analysis of included studiesIncluded studies contain those used in wholegrain meta

analysis i.e. Same cohorts, same validated food intake questionnaires and same follow-up period!

Meta Analysis studies ranked by date demonstrates improved flavanol identification of food consumption

Meta Analysis plotted as “forest plot” to show Risk Ratios


Meta-Analysis

0.72

0 1 2

Geleijnse et al, 2002 (16)

Knekt et al, 2002 (13)

A rts et al, 2001 (18)

Hirvonen et al, 2001 (19)

Hirvonen et al, 2001 (19) (F)

Hertog et al, 1997 (21)

Knekt et al, 1996 (22) (1)

Knekt et al, 1996 (22) (2)

Rim m et al, 1996 (23) (1)

Rim m et al, 1996 (23) (2)

Hertog et al, 1993 (24)

A rts et al, 2001 (18) (F)

Sesso et al, 2003 (15) (F)

Geleijnse et al, 2002 (16) (F)

Knekt et al, 2002 (13) (F)

A rts et al, 2001 (17) (F)

Yochum et al, 1999 (20) (F)

A rts et al, 2001 (18) Table 2 49.1-85.8 m g/d CHD

Arts et al, 2001 (18) Table 2 85.9-355.4 m g/d CHD

Arts et al, 2001 (18) Table 2 M II 49.1-85.8 m g/d

Arts et al, 2001 (18) Table 2 M II 85.9-355.4 m g/d

Arts et al, 2001 (18) Table 3 S troke 49.1-85.8 m g/d

Arts et al, 2001 (18) Table 3 S troke 85.9-355.4 m g/d

Arts et al, 2001 (18) Table 3 S troke inc idence, 49.1-

A rts et al, 2001 (18) Table 3 S troke inc idence, 85.9-

M ennen et al (25) Table 3 CVD M en, 2nd Tertile,

M ennen et al (25) Table 3 CVD Wom en, 2nd Tertile

M ink et al (26) Table 5 CHDPostm enapausal Wom en,

M ink et al (26) Table 5 CHD Postm enapausal Women,



M ink et al (26) Table 5 CVDPostm enapausal Wom en,

M ink et al (26) Table 5 CVD Postm enapausal Women,



Sesso et al, 2003 (15) (F) Table 2 CHD > 60.6 m g/d

Sesso et al, 2003 (15) (F) Table 2 CVD Events > 60.6

Sesso et al, 2003 (15) (F) Table 4 CVD > 1 apple/day

Bayard et al, 2007 (27) Int. J . M ed. Sc i. 2007, 4, A ll

Bayard et al, 2007 (27) Int. J . M ed. Sc i. 2007, 4,



Bayard et al, 2007 (27) Int. J . M ed. Sc i. 2007, 4, IHD,

Overall

Log Odds R atio (95% C I)

Stroke only

34,489 postmenopausal women Iowa Women’s Health Study

45,000 Kuna Indians in San Blas compared to mainland Panama

Favours Control

0.72 Risk Ratio

Point Size ~ significance

Neutral

Favours Flavanols

0.52 Kuna Indian Risk Ratio Total Cohort subjects (excluding duplicate analysis) = 3,087,122

16 key studies included

Meta Analysis includes studies based on CHD, MI & stroke endpoints.

Includes studies used in wholegrain Meta Analysis.

More recent studies have picked out Flavanol consumption data -USDA Flavonoid Database (2007)


Human intervention studiesCriteria Included Studies 1990 – 2007

Bioavailability – i.e. Absorbed from food group – only double blind, randomised, crossed over studies 178 studies, 20 main studies selected “Flavanol monomers are absorbed as metabolites”

Vasodilatation – i.e. Increased vascular compliance – only double blind, randomised, placebo controlled cross-over studies 145 studies, 56 main studies selected “Flavanol monomers enhance eNOS induced vascular relaxation

helping to reduce arterial stiffness”


Vascular compliance


4% increase in brachial 4% increase in brachial artery diameterartery diameter

Impaired endothelial cell Impaired endothelial cell function triggers the function triggers the development of plaques development of plaques in blood vessels...in blood vessels...

Improved vascular Improved vascular compliance reduces the compliance reduces the formation of plaque formation of plaque deposits and improves deposits and improves the circulation...the circulation...

People who eat flavanol-People who eat flavanol-rich fruit have more rich fruit have more compliant vasculature...compliant vasculature...

““...Its why fruit is good for you!”...Its why fruit is good for you!”

Pre-clinical Trials - Evesse

Organic Organic Juice TrialsJuice Trials

Low-fat Low-fat Yogurt TrialsYogurt Trials

Note: Note: 1)1)Organic juice + 1mg/kg (body weight) EvesseOrganic juice + 1mg/kg (body weight) Evesse2)2)Low-fat Yogurt + 70 mg of EvesseLow-fat Yogurt + 70 mg of Evesse3)3)Based on photoplesmographyBased on photoplesmography


Equal to 4% Equal to 4% vasodilatation vasodilatation

ControlControl

ActiveActive

Pre-clinical Trials - Evesse

Organic Organic Juice TrialsJuice Trials

Low-fat Low-fat Yogurt TrialsYogurt Trials

Arterial Stiffness Index Arterial Stiffness Index Vascular AgeVascular Age


Human & Animal Trials


Bio-active amount <1 Bio-active amount <1 mg/kg/BWmg/kg/BW

Human Animal

Source: SafeBridge Consultants Inc, Toxicological Risk Assessment 2007

ConclusionsEvesse is a bioactive flavanol functional food with proven

benefitsAn Article 13.1 health claim based on maintaining good

circulation has been submitted to the FSA / EFSADue diligence allows Coressence to support its health

claim with good scienceFurther clinical trials to take place in 2008, including

12 month intervention beginning January 2008Other epidemiology and historical epidemiology to be

published in 2008


evesse® “... its why fruit is good for you!” richard wood chief executive coressence limited...

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