Dr Dilip Ghosh - Soho Flordis International - Health Regulations: Another Challenge for Supplying Growing Asian Consumption Demands

1 Subsidiary companies of Soho Flordis International Pty Ltd

Health Regulations Another Challenge in meeting Asian

Consumption Demands

The Asia Pacific Food and Fibre

Summit, 30-31 Oct 2014, Melbourne

FUNCTIONAL DIETARY FIBER

Dilip Ghosh, PhD, FACN, MAIFST

SFI Pty Ltd, Sydney, Australia

[email protected]

+61 (0) 449154917

mailto:[email protected]

Strictly Confidential © Soho Flordis International Pty Limited 2014 [Last updated: April 2014]


Overview

1. Introduction: General

2. Regulatory definitions

3. Market-Growth & Operators

4. Health Claims

5. Unique Case Study: FBCx

3


1. Introduction: General

4


What is Fiber?

• Non-digestible part of plant foods

• Important for maintaining good

health

• Most adults (read Americans)

only eat about half of the fiber

they need!


Sources of Fiber

Whole Grains

Fruits

Vegetables

Beans

Nuts

Seeds


Harmonisation? More differences? Source: ILSI 2012

7

FDA Health Canada Codex

Nutrition Facts Panel Dietary Fiber Dietary Fiber

Dietary Fiber

Degree of

polymerisation

≥3

≥3

≥10

Isolated & synthetic

non-digestible CHOs

Yes*

*Positive list after

petition review

Yes*

*Positive list after

voluntary petition

review

Yes

AI methods (AOAC

2009.01 & 2011.25

Yes*

*Yet to be validated

Yes

Yes

Caloric value (kcal/g) Soluble 2; Insoluble 0 2* N/A

Physiological Benefits Not specified:

Physiological effects

beneficial to human

health*

*Such as attenuation

of pp blood glucose,

cholesterol &

improved laxation

Non-exclusive list:

• Laxation/Reg/Bulk

• Blood lipids

• Blood glucose/Ins

• Colon fermentation

Not specified:

‘Physiological effect

of benefits

demonstrated by

generally accepted

scientific evidence to

competent

Authorities’


Why is Dietary Fiber Important?

Improves laxation or regularity by increasing stool bulk;

Reduces blood total and/or low-density lipoprotein

cholesterol levels;

Reduces post-prandial blood glucose and/or insulin levels;

Provides energy-yielding metabolites through colonic

fermentation.


Not All Fiber is Created Equal

Insoluble Fiber

Keeps you “regular”

Found in whole wheat products, bran, nuts, and

many vegetables

Soluble Fiber

“Heart Healthy”

Found in oats, corn, peas, beans, apples, citrus

fruits, and carrots

We need BOTH!!


Dietary Fiber: Variations in water

hydration, fat absorption capacity

10

DF source DF (%) Water hydration

(g/g)

Fat absorption

capacity (g/g)

Sunflower heads 19.5 4.15 4.4

Psyllium seeds 7.9 10.05 0.8

Linseed hulls 13.0 8.05 1.8

Wheat bran 9.8 3.15 2.0

Pea hulls 34.6 2.55 0.8

Cellulose 63.5 1.95 2.0


Dietary Fiber: Variations in water

hydration, fat absorption capacity

11

DF source DF (%) Water hydration

(g/g)

Fat absorption

capacity (g/g)

Sunflower heads 19.5 4.15 4.4

Psyllium seeds 7.9 10.05 0.8

Linseed hulls 13.0 8.05 1.8

Wheat bran 9.8 3.15 2.0

Pea hulls 34.6 2.55 0.8

Cellulose 63.5 1.95 2.0

Fat binding capacity: 1:9


Fiber and Disease Prevention

Fiber can help prevent: Obesity

Type 2 diabetes

Diverticulitis

Colon cancer

Heart Disease


2. Regulatory definitions

13


Legal Definition

14

1) Carbohydrates with a DP (degree of polymerization or number of

saccharide units) of 3 or more that naturally occur in foods of plant origin

and that are not digested and absorbed by the small intestine; and

2) Accepted novel fibres*

1) Naturally occurring edible carbohydrate polymers;

2) Carbohydrate polymers obtained from food raw material by physical,

enzymatic or chemical means; and

3) synthetic carbohydrate polymers (generally more than 10 monomeric

units, but 3-9 units are also acceptable in few countries)**

*Health Canada, 2012

**Codex Alimentarius Commission, 2010

“Dietary fibre consists of:


Physiological Benefits: Regulatory aspects

15

Health Canada 2012 (non-exclusive list) • Improve laxation or regularity by increasing stool bulk

• Reduces blood total &/or LDL cholesterol

• Reduces pp blood glucose &/or insulin levels

• Provides energy-yielding metabolites through colonic fermentation

Vahouny 2010, Maryland, USA Symposium • Reduced total and/or LDL cholesterol

• Attenuation of postprandial glycemia/insulinemia

• Reduced blood pressure

• Increased fecal bulk/laxation

• Decreased transit time

• Increased colonic fermentation/SCFA production

• Positive modulation of colonic microflora

• Weight loss/reduction in adiposity

• Increased satiety


How Much Fiber Do You Need?

Males (14-50 years old) =

38 grams/day

Females (9-50 years old) = 25 grams/day

On average we need about 14 grams of fiber

per 1000 calories (e.g. for a 2000 calorie diet: 14 x 2 = 28 grams)


3. Market-Growth & Operators

17


The top eight players in the dietary

fiber industry held a market share of

around 65.0%

18

Cargill Inc. (U.S.)

E.I. DuPont de Nemours (U.S.)

Lonza Group (Switzerland)

Roquette Freres (France)

Ingredion (U.S.)

SAS Nexira (France)

SunOpta (Canada)

Tate & Lyle (U.K.)


Leading Brands

19

• Benefiber (Novartis Consumer Health Inc.)

• Metamucil (Procter & Gamble)

• Citrucel (GlaxoSmithKline Consumer Healthcare LP)

• Fiber Choice (GlaxoSmithKline Consumer Healthcare LP)

http://www.metawellness.com/our-products.php


Market growth & the changing dynamics

of consumption pattern in the Asian

developing economics

20

2007 • Personal income

rises exponentially

• Less debt than their

western

counterparts

• Financial institutes

are in better shape

• More profits from

Asia, e.g. P&G,

Nestle, Heinz

• Middle class

consumers

outnumbered the

whole population of

Europe & N America


DF usage: Pharmaceutical vs. Food

21

Dietary Fiber Market worth $4,210.0 Million by 2019

Markets&Markets 2014


4. Health Related Claims

22


Conditions for nutrition content claims

23

Descriptors for the

dietary fibre nutrition

content claim

CoPoNC qualifying

criteria

Standard 1.2.7

qualifying criteria

(FSANZ)

g dietary fibre per serving

Source 1.5 2

Good source 3 4

Very high or Excellent

source

6 7


Qualifying criteria for DF in Standard 1.2.7,

CoPoNC and international regulations and

guidance

24

Descriptors for

dietary fibre

nutrition

content claims

Standard 1.2.7

2013

CoPoNC

1995

Canada

2003

EU

2006

Codex

2009

USA

2008

Source 2 g per serving

(6.7% of reference

value (30g))

1.5 g per serving 2 g per reference

amount and

serving of stated

size

3 g/100g or

1.5 g/100 kcal

3 g/100g or

1.5 g/100kcal or

10% of dietary

reference value

per serving

10-19% of Dietary

Reference Value

(25g) per

prescribed RACC

(for good source,

contains or

provides claims) Good source

or high

4 g per serving

(13.3% of

reference value

(30g))

3 g per serving 4 g per reference

amount and

serving of stated

size

(‘high’ is used,

‘good’ is not

permitted)

6 g/100g or

3 g/100 kcal

6 g/100g or

3 g/100kcal

or

20% of dietary

reference value

per serving

Excellent

source or very

high

7 g per serving

(23.3% of

reference value

(30g))

6 g per serving 6 g per reference

amount and

serving of stated

size

(‘very high’ is

used, ‘excellent’

is not permitted)

Not permitted Not permitted 20% of Dietary

Reference Value

(25g) per

prescribed RACC

(for high, rich,

excellent claims)


Fibre points (F points)*

25

*Depending on the amount of dietary fibre in the food product. A maximum of five

points can be awarded.

Points DF (g) per 100 g or 100 mL

0 ≤0.9

1 >0.9

2 >1.9

3 >2.8

4 >3.7

5 >4.7


Fiber and the Food Label

3 grams per serving Good Source of Fiber

≥ 5 grams per serving Excellent Source of Fiber


Fiber and the Food Label

Choose foods with a whole grain ingredient listed first on the label’s ingredient list.

Adapted from University of Nebraska Lincoln (www.lancaster.unl.edu)

Strictly Confidential © Soho Flordis International Pty Limited 2014 [Last updated: April 2014] 28

The Institute of Medicine of the National Academy of

Sciences publishes the Dietary Reference Intakes (DRI) for

dietary components, including macronutrients, vitamins,

minerals, and fiber. The DRIs consist of the RDAs, EARs,

AIs, and ULs.

Recommended values are provided for each life cycle

group—from birth through childhood, sexual maturity,

midlife, and old age.

What could this mean for you?:

Dietary Reference Intakes (DRI)


Recommended Dietary

Allowance (RDA)

The average daily intake

level sufficient to meet

the nutrient

requirements of 97 to 98

percent of healthy

individuals.

Tolerable Upper Level (UL)

The highest level of daily nutrient intake that is likely to pose no risks of adverse health effects to almost all individuals in the general population.

DRI-continues


Estimated Average

Requirement (EAR)

The nutrient intake

value sufficient to

meet the requirements

of half the healthy

individuals in a group.

The Nutrient Content

of the U.S. Food Supply

Series uses this DRI for

nutrient comparisons.

Adequate Intake (AI) The recommended daily intake based on approximations of nutrient intake by a group (or groups) of healthy people. It is used when the RDA cannot be determined.

DRI-continues


Regulatory status of DF in Europe

31

Category Health Claims EFSA Journal

Konjac Blood cholesterol 2009, 7(9): 1258

Pectin Blood cholesterol & glucose level 2010, 8(10): 1747

Resistant starch Blood glucose 2011, 9(4): 2022

Arabinoxylan Blood glucose 2011, 9(6): 2205

Chitosan Blood cholesterol 2011, 9(6): 2214

Alpha-

cyclodextrin

Post-prandial glycemic response;

Post-prandial lipid metabolism

(under process)

2012, 10(6): 2713


Regulatory opinions on Alpha-cyclodextrin (ACD)


5. Unique Case Study- FBCx

33


FBCx Introduction

Clinically proven

Eliminates the fat in foods with impressive fat binding properties

Health benefits including:

Improved cholesterol and triglyceride levels

Improved insulin sensitivity

Weight management

Protected by a family of over 40 patents worldwide for fat

binding, weight loss, metabolic syndrome markers and cholesterol

lowering uses in food, beverages and in medicine applications

34


FBCx is αlpha-cyclodextrin

Naturally occurring soluble fibre

Consists of 6 glucose molecules that are

connected end-to-end

This toroidal structure imparts unique

properties to this fibre that allows it to

form a stable non-digestible complex

with dietary fat

Just as the fibre-fat complex is non-

digestible, it is also non-fermentable,

thus eliminating messy side effects

35


FBCx – the ‘Super’ Fibre

Fibre and its health benefits are well regarded:

fosters weight management by calorie displacement

lowers blood cholesterol

may reduce the risk of breast and colon cancer

helps prevent or alleviate haemorrhoids

reduces risk of appendicitis

reduces risk of developing diverticulitis

Typically dietary fibres bind fat on about a 1:1 ratio

- Disorganised fibre! - variable in structure

FBCx is the only fibre to bind 9 x its weight in dietary fat

Pure and defined molecular structure

Safe

Natural fibre, purified and sourced from maize. Generally recognised

as Safe (GRAS) worldwide as a food

36


Mode of Action

37


FBCx – Binds to Dietary Fat & Eliminates

FBCx works in the gastro-intestinal tract to prevent the absorption

of dietary fat:

FBCx forms a stable non-digestible complex with dietary fat in the

digestive tract, rendering the fat resistant to lipase activity, so that

the fat cannot be absorbed

Consequently the FBCx-fat complex passes through the bowel without

being absorbed

Preferentially binds to saturated and trans fats

Just as the fibre-fat complex is non-digestible, it is also non-

fermentable, thus eliminating unwanted side effects

38

fbcx-final_v02a.mp4

fbcx-final_v02a.mp4


FBCx Research & Clinical Trials

39


FBCx Pre Clinical Studies

40

1. Artiss JD et al. The effects of a new soluble dietary fiber on weight gain and selected blood parameters in rats. Metabolism Clinical and

Experimental 55 (2006) 195– 202

2. Wagner EM et al. Dietary α–Cyclodextrin lowers low-density lipoprotein cholesterol and alters plasma fatty acid profile in low-density

lipoprotein receptor knockout mice on a high-fat diet. Metabolism Clinical and Experimental 57 (2008) 1046–1051

Prevention of body weight gain despite introduction of high fat diet,

reduction in serum triglyceride levels by 30%, reduction in leptin

levels, increased insulin sensitivity and faecal fat excretion1

Further supported positive benefits on cardiovascular health with

lower levels of the proatherogenic components LDL cholesterol and

apolipoprotein-B demonstrated as well as lower saturated fat blood

levels2


Study: Comerford KB et al.

Study Design: Double-blind, controlled crossover study

Treatment: 2 FBCx tablets with each fat containing meal (a total of 6 tablets per

day)

Participant Profile: N = 41, overweight not obese (BMI 25-30kg/m2), 18-65 years

Duration: t = baseline, 1 month & 2 months

Results: Reduction in total cholesterol 5.3% and LDL (both p<0.05)

Significantly lowered LDL Cholesterol/Apolipoprotein B

Small weight loss in the absence of dietary change (p<0.05)

FBCx Overweight Not Obese Study

41

* Comerford KB et al. The Beneficial Effects α–Cyclodextrin on Blood Lipids and Weight Loss in Healthy Humans. Obesity 19 (2011) 1200–1204


Study: Grunberger G et al.

Study Design: Double-blind, placebo controlled

Treatment: 2 FBCx tablets with each fat containing meal (a total of 6 tablets per

day)

Participant Profile: n= 66, obese diabetics (BMI 30 kg/m2), 30 years

Duration: t = baseline, 1, 2 and 3 months

Results: FBCx halted the weight gain, placebo group showed significant gain

(p<0.01)

Significantly reduced blood cholesterol (p<0.05) and LDL-cholesterol

levels in patients with high blood fat levels

Blood adiponectin levels increased (p<0.05)

“it can be easily incorporated into a diabetic management regimen”

FBCx Obese Diabetic Patients

42

* Grunberger G et al. The benefits of early intervention in obese diabetic patients with FBCxTM – a new dietary fibre. Diabetes/Metabolism

Research and Reviews 23 (2007) 56–62


Study: Jarosz PA et al.

Study Design: Double-blind, placebo controlled cross-over study. Self control.

Treatment: 2 FBCx tablets with McDonald’s breakfast with 27g fat (10g saturated)

Participant Profile: n= 34 aged 18-65, mean BMI 25.04

Measurement Timepoints: Baseline and acute response: 1, 2 & 3 hours post prandial

Result: Significant reduction in acute postprandial blood triglyceride levels

FBCx Acute TG - “McMuffin” Clinical Trial

43

* Jarosz PA, et al, The Effect of α-Cyclodextrin on postprandial lipid and glycemic responses to a fat containing meal, Metabolism (2013)


Running Protocol: National Institute Health (NIH)

44

Currently underway with NIH (US)-last phase of recruitment

Results expected early 2015

Endpoints of the study are:

Body weight change

GI symptoms

Glucose

ATL

Total cholesterol

LDL, HDL cholesterol

Triglycerides

C-Reactive protein


Running Protocol: Structure – Function Trial

45

Faecal fat trial proving structure-function in clinical study

Goals

Establish “galenic equivalence” through blood triglyceride data

Correlate faecal fat data with blood triglyceride data

Investigate initial gut flora effects in one or more galenic forms

End-points

acute blood triglyceride (as per existing pilot tablet study)

Faecal (complexed) fat - using new extraction technique

+/- Faecal Flora analysis

Study arms

Placebo + all galenic forms

+/- Beverage or Food arms (co-funded with marketing partners)

Location: US CRO


Upcoming Trial: Metabolic Syndrome Trial (June ‘14-Dec’15)

46

Study Details

Placebo + 1000mg tablet +/- MD211

6 months, double blind, placebo + 6 Month follow up (13 months total)

Goals

Obtain Weight loss, Cholesterol lowering, Insulin sensitivity or “metabolic

syndrome” claims

Investigate effect of co-administration with blood sugar lowering product

(MD211)

Obtain preliminary data on mood, satiety and other novel endpoints

End-points

Weight, waist circumference, BMI, Blood Pressure, Impact of Weight on Lifestyle

Questionnaire (IWOLQ), Dietary Intake Diary, Pedometer reading

Cholesterol, HDL, LDL, Blood Triglycerides, Liver Enzymes

Blood Glucose, Insulin, C reactive protein, HBA1c (glucose tolerance), Apo-

lipoprotein

Location

University of Sydney, Australia (Multicentre, mixed racial cohort of Sydney)


FBCx Market Opportunity

47


FBCx Market Insights

48

The developed and developing world is faced with the twin

epidemics of Obesity and Type 2 Diabetes

Two-thirds of the adult population of the USA and one-quarter of

the children are overweight or obese

Asian countries are quickly catching-up to the high rates of the

West

India and China have the first and second largest diabetic

populations in the world

The opportunities for a clinically proven, effective weight loss

products with health benefits for metabolic syndrome and the diet

market


FBCx Target Markets

49

Patients

Consumers


FBCx Target Markets - Patients

50

Patients with early metabolic syndrome

Clustered symptoms:

high blood triglycerides

overweight

raised blood pressure (hypertension)

impaired fasting glucose (IFG) or diabetes

Poor compliance to diet and lifestyle advice (~15%)

difficult to change habits and maintain


FBCx is a safe treatment option in response to signs of early

metabolic syndrome

Without the serious side effects that synthetics can have and the

undesirable side effects associated with lipase inhibitors (Orlistat -

leakage)

Clinically researched

FBCx Target Markets - Patients

51

Triglycerides,

cholesterol

Insulin

sensitivity

Weight

management


Easy to understand how it works & benefits

- point of difference in the confusing diet market

Superior fat binding – up to 9x

Natural, safe, no unwanted side effects

Stimulant free, heart healthy

Clinically researched

FBCx Target Markets – Dieting consumers

52

Eliminates up to 500 calories per day


Approved in USA as Dietary Supplement and NPN in Canada

Launched mid 2013 in US with SFI Brand ‘Calorease’

Scientific, clinically researched, recommended brand image

Marketing program including: social media, public relations

(PR), in-store recommender education, endorsement –

bloggers & personalities, store programmes & advertising

National listing in GNC stores, FDM stores mid 2014

FBCx Dieting Products - CaloreaseTM

53


Bridal Cards with Walgreens “Tag”

54


Education and nutritional blogger outreach results in 821,726

impressions of Calorease review from 85 nutritional bloggers

5,889 Facebook followers

81.66% growth in new visits to web site year to date

6,000 Subscribers - Online Newsletter, Brides Against Breast Cancer,

Great Bridal Expo

13,000 Calorease samples provided to bridal show attendees

Pre-Market Launch & Current Activity: Social

Media Program, PR & Sampling

55


Calorease marketing toolbox

FBCx – Calorease Collateral

56

www.calorease.com

http://www.calorease.com/

https://twitter.com/calorease

http://www.youtube.com/calorease

https://www.facebook.com/calorease

https://plus.google.com/110030431884042339328/posts

http://pinterest.com/calorease/


Functional food (sachet) launched in Australia in Sept 2013 with

SFI partner, top weight loss brand

TV advertising, store promotions and displays, social media

FBCx Dieting Products – Calorie Magnet

57


FBCx – Dr Oz Coverage

58

February 2014

Digital imprint

DrOzShowClip-highres.mp4


FBCx Product Options

59

Clinically proven products – FBCx tablets & powder (following running

protocol). Marketing these products to healthcare professionals is

suitable under the Flordis umbrella brand for natural, clinically proven

products

Alternative product formats can be used to widen the product offering

or assist differentiation for different brands & target markets

Tablets, powder, other - FBCx is readily soluble dietary fibre –

neutral taste, odourless, haze–free, colourless, low viscosity

FBCx branded ingredient (under development with top 10 VMS and

Nutraceutical companies in US). Global beverage & food company

partnerships for functional beverage & food applications development

Opportunity to market alternative brands to target different market

segments


Summary

60


FBCx Summary

Clinically researched, proven results and tolerability

Eliminates the fat in foods with competitive advantages of superior fat

binding capacity and natural, safe, devoid of side effects credentials

Health benefits including:

Improved cholesterol and triglyceride levels

Improved insulin sensitivity

Weight management

Patented fat binding and health claims

Patient (healthcare professional) and consumer targeting opportunities

61


5. Summary

62

The Nutraceutical World,

2014


Future Dream Fiber

63 Jakobsdottir et al 2014


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