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
+61 (0) 449154917
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Overview
1. Introduction: General
2. Regulatory definitions
3. Market-Growth & Operators
4. Health Claims
5. Unique Case Study: FBCx
3
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1. Introduction: General
4
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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!
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Sources of Fiber
Whole Grains
Fruits
Vegetables
Beans
Nuts
Seeds
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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’
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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.
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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!!
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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
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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
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Fiber and Disease Prevention
Fiber can help prevent: Obesity
Type 2 diabetes
Diverticulitis
Colon cancer
Heart Disease
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2. Regulatory definitions
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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:
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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
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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)
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3. Market-Growth & Operators
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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.)
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Leading Brands
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• Benefiber (Novartis Consumer Health Inc.)
• Metamucil (Procter & Gamble)
• Citrucel (GlaxoSmithKline Consumer Healthcare LP)
• Fiber Choice (GlaxoSmithKline Consumer Healthcare LP)
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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
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DF usage: Pharmaceutical vs. Food
21
Dietary Fiber Market worth $4,210.0 Million by 2019
Markets&Markets 2014
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4. Health Related Claims
22
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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
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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)
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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
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Fiber and the Food Label
3 grams per serving Good Source of Fiber
≥ 5 grams per serving Excellent Source of Fiber
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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)
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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)
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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
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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
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Regulatory status of DF in Europe
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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
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Regulatory opinions on Alpha-cyclodextrin (ACD)
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5. Unique Case Study- FBCx
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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
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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
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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
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Mode of Action
37
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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
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FBCx Research & Clinical Trials
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FBCx Pre Clinical Studies
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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
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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
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* Comerford KB et al. The Beneficial Effects α–Cyclodextrin on Blood Lipids and Weight Loss in Healthy Humans. Obesity 19 (2011) 1200–1204
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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
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* 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
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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
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* Jarosz PA, et al, The Effect of α-Cyclodextrin on postprandial lipid and glycemic responses to a fat containing meal, Metabolism (2013)
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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
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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
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Upcoming Trial: Metabolic Syndrome Trial (June ‘14-Dec’15)
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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)
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FBCx Market Opportunity
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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
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FBCx Target Markets
49
Patients
Consumers
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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
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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
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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
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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
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Bridal Cards with Walgreens “Tag”
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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
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Calorease marketing toolbox
FBCx – Calorease Collateral
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www.calorease.com
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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
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FBCx – Dr Oz Coverage
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February 2014
Digital imprint
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FBCx Product Options
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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
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Summary
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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
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5. Summary
62
The Nutraceutical World,
2014
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Future Dream Fiber
63 Jakobsdottir et al 2014
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Subsidiary companies of Soho Flordis International Pty Ltd www.sfihealth.com
Soho Flordis International Pty Ltd
A.C.N. 137 788 491
PO Box 1027 Crows Nest,
NSW 1585 Australia
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Australia
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c/o Soho Flordis International Pty Ltd
Level 4, 156 Pacific Highway,
St Leonards NSW 2065
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