Product presentation Product presentation

Product presentation
Product presentation Content Content
• Product description • Manufacturing • Mechanism of action
M h i
f ti
• Clinical studies
Clinical studies
• Key competitive advantage y
p
g
Product description
Product description • LuraLean® is vegetable fiber which the chemical structure is the pure form of propol manana
• Fiber in LuraLean is obtained from the Amorphophallus Propol plant grown in Japan
• 100 % natural way to reduce weight with no chemical effect on organism • Clinical approved effect Product effect
Product effect •
•
•
•
•
•
•
Regulates appetite
Regulates extra‐calorie absorbation
Regulates cholesterol absorption
I
Improves metabolism
t b li
Delays gastric emptying time
Enhances intestinal health
Enhances intestinal health
Enhances immunity capacity
Approved by European Food Safety Authority – 2010 Authority 2010
•
•
•
•
•
•
•
•
Reduction of body weight
y
g
Reduction of post‐prandial glycemic responses
Maintenance of normal blood glucose concentrations
Maintenance of normal (fasting) blood concentrations of triglycerides
Maintenance of normal blood cholesterol concentrations
Maintenance of normal blood cholesterol concentrations
Maintenance of normal bowel function
Decreasing potentially pathogenic gastro‐intestinal
Decreasing potentially pathogenic gastro
intestinal microorganisms
Improves intestinal micro flora Manufacturing g
Manufacturing (1)
Manufacturing (1) LuraLean (Propol Mannan)
Propol Mannan
A Selected Species among Konjac Plant family.
Very
Qualifies to be
V few percentage
f
Q lifi
b
processed as LuraLean
• Extraction / polish technology
Most Purified form
Functional essence
• Molecular Weight Control
• 14 Safety Studies
Over 100 Clinical data solely on Propol Mannan
• 518 Agro‐Chemical free
• 300 – year plantation know‐how
• Zero detection for So2 and Arsenic
Glucomannan
Konjac Flour
Standardized
Glucomannan
Few data as abstergent
No Clinical Data for Cholesterol, Diabetes, Weight Loss
Refined Konjac
No Clinical Data Mostly
No
Clinical Data Mostly High Sulfite and High Sulfite and
Arsenic levels (Requires pre‐processing
before use)
Konjac Flour
(Pre‐treated powder)
Need to take out enzyme and other impurities before
human consumption
7
Manufacturing (2)
Manufacturing (2) • Natural
Natural Source
Source = Amorphophallus propol (Amorphophallus K. = Amorphophallus propol (Amorphophallus K
Koch) plant Selected source
ƒ Proprietary production chain & process
Warranty of Clinical functionality & Safety
8
Mechanism of Action Mechanism of Action (1)
Mechanism of Action (1) 0‐Calorie Stomach
Filler
Made with pure fiber
Brain signal:
« Some food is in! »
Prevents
Overeating
Mechanism of Action (2)
Mechanism of Action (2) Viscosity‐giving
Viscosity
giving
property
Food moves slowly
Food
moves slowly in in
the body
In vitro Change of Viscosity with Time
Glycemic Control Control
Prolonged Satiety
Mechanism of Action (3)
Mechanism of Action (3) Oil‐Adsorbing
Oil
Adsorbing
property
Fat‐trapping magnet
No Extra energy
No Extra energy absorption
The Oil‐Trapping
The Oil
Trapping Demo
Hydrated LuraLean
Mix with Olive Oil
Mimics the movement in the stomach and in the intestines
No Oil Release in water!
Oil and Fats are Trapped in the hydrated layer with its micelle effect
and « the fatty extras » will be carried out of your body through the system Mechanism of Action (3)
Mechanism of Action (3) Effects of LuraLean on Gastric Emptying
60 min
80 min
60 min
80 min
Without LuraLean
L L
LuraLean
(Propol Mannan)
Capsules p
free your body from :
free your body from :
•
•
•
•
•
•
Overweight
Bad cholesterol
B d h l t l
Triglycerides
Abdominal fat –tiny
Abdominal fat tiny waist
waist
Blood glucose Bad bacteria in the intestines
all that in a natural way, without chemicals!
Product position in shops
Product position in shops Clinical Studies Clinical study results
Clinical study results • Loss 2.4 kg of pure fat for 4 weeks
• Reduction in waist circumference of 2.8 cm for 8 weeks
f
f
f
Reduce of LDL ("bad")
bad ) cholesterol by 20% in three weeks
cholesterol by 20% in three weeks
• Reduce of LDL (
• Reduction of blood glucose by 30% for 4 weeks
• Reduction of triglycerides in the blood and up to 36% for 8 weeks
University of Connecticut Study
Body Composition significantly improved selectively on Lowering
« Effect of adding axercise to a diet containing glucomannan »
W.J. Kraemer et al., University of Connecticut Metabolism
Clinical and Experimental 56 (2007) 1149‐1158
1’500 mg intake
at 2 largest meals/day
‐ Body Weight
‐ HDL Cholesterol
‐ Body Fat %
Body Fat %
‐ Abdominal % Fat
Abdominal % Fat
‐ Total Fat Mass
‐ Abdominal Fat Mass
‐ Leptin Levels
‐ Waist Circumference
Published Clinical Study 1: Effect of Propol mannan
on Obese Patients
Walsh David E., Gaghoubian Gazgen, Behgorooz Ali; International Journal of Obesity; 289‐293, 1983
Subjects
20 obese Patients (women)
20 obese Patients (women)
Methods
Double‐blind placebo control study for 8 weeks
‐ Active – 1 g (0.035 oz) of Stralean taken 1 hour prior to meals
‐ Placebo
‐ No Dietary Changes – Patients eat/drink whatever they like
Measurements
‐ Body Weight
Body Weight
‐ Triglycerides
‐ Serum Cholesterol
‐ LDL Cholesterol
‐ HDL Cholesterol
Results
‐ Significant Mean Weight Loss (5.5 lbs)
‐ Significant Reduction of Serum Cholesterol (21.7 mg/dl)
‐ Significant Reduction of LDL Cholesterol (15.0 mg/dl)
Results Results
Weight Loss After 8 Weeks of LuraLean ® 1 g / meal
3 g ((0.106 oz)/day
) y of LuraLean
Chan
nge in body
y weight (lbs
s) vs
base
eline
2
1.5
1
0
-0.4
-1
4 Weeks
8 Weeks
-2
-3
-4
-5
-4.9
-5.5
-6
LuraLean
Placebo
Significant Weight Loss
21
Cholesterol and Triglycerides improvement after 4 and 8 Weeks of LuraLean®1g / meal
g/
3 g ((0.106 oz)/day
) y of LuraLean®
C
Change
in cholesterol a
and
trigllycerides (m
mg/dl) vs bas
seline
20
18.6
15
10
5.9
5
4 weeks
LuraLean
5.9
4.7
0
-2.1
-2.6
-5
5
8 weeks
LuraLean
4 Weeks
Placebo
-10
-15
-14.8 -15
8 Weeks
Pl
Placebo
b
-15.5
-20
-20.9 -21.7
-23.4
-25
Cholesterol
LDL
Cholesterol
Triglycerides
Significant Well‐balanced Improvements
Effects of LuraLean on serum bile acids in healthy subjects – Egg yolk loading test
subjects Egg yolk loading test
with LuraLean®
without LuraLean®
DECREASES
• Total Cholesterol by 9.7%
• LDL Cholesterol by 7.3 %
• Total Triglycerides by 21.0%
Total Cholesterol changes in patients treated with
L L ® (A) L L ®
LuraLean® (A), LuraLean® + restricted calorie regimen
(B), Placebo (C)
LuraLean® is the solution that helps you to p
g
y
y
reduce Lipids significantly and safely
Triglycerides changes in patients treated with
L L ® (A) L L ®
LuraLean® (A), LuraLean® + restricted calorie regimen
(B), Placebo (C)
Published Clinical Study 2: Double‐blind Evaluation of Propol Mannan vs placebo in Postinfracted patients after cardiac Rehabilitation
Reffo G.C., Ghiradi P.E., Forantini C., Current Therapeutic Research, Vol. 47; 753-758, 1990
Subjects
28 Post infarcted cardiac patients after rehabilitation (24 men & 4 women –
average age: 54)
Methods
Double‐blind placebo control study for 8 weeks
‐ Active (15 subjects) Active (15 subjects) – 1.5 g (0.053 oz) of LuraLean taken
1.5 g (0.053 oz) of LuraLean taken before
breakfast and dinner
‐ Placebo (13 subjects)
‐ No Dietary Changes – Patients eat/drink whatever they like
Measurements
‐ Heart Rate
‐ Blood Pressure
‐ Cholesterol
‐ Body Weight
Results
0 Week
8 Weeks
Cholesterol
235
215
SBP
144.6
137.3
Results Results
Weight Loss After 8 Weeks of Twice Daily LuraLean® Supplementation
3 g (0.106 oz)/day of LuraLean ®
0.4
Change in b
body weight (kg
g)
vs baseline
0.5
0
-0.5
-1
-1.5
2
-2
-2.5
-3
-3.5
-3.2
LuraLean
Placebo
Significant Weight Loss
Weight Loss
Published Clinical Study 4: Chronic use of LuraLean in the Dietaryy Treatment of Severe Obesityy
Vita P.M., Restelli A., Caspani P., Klinger R.; Minerva Med; 135-139, 1992
Subjects
50 obese Patients (15 men & 35 women – average age: 39)
Methods
Double‐blind placebo control study for 8 weeks
‐ Group A: 4 g (0.141 oz) / day of LuraLean to be taken in 3 doses
‐ Group B: Placebo + Diet
G
B Pl b Di therapy
h
‐ Group A+B: Prepared meals were offered
Measurements
‐ Body Weight ‐ Triglycerides
‐ Glycemic values
‐ Cholesterol
‐ Intestinal Function
Results
… (LuraLean group)… had a more significant weight loss in relation to the fatty
mass alone, an overall improvement in lipid status and carbohydrate tolerance, and a greater adherence to the diet in the absence of any relevant side effects. »
… ( ura ean diet supplements)
… (LuraLean diet
supplements) have been found
have been found to
to be
be particularly efficacious
and well tolerated even in the long‐term treatment of severe obesity. »
Private Study 5 (Child Obesity Study): Pharmacologic
intervention program in infantile obesity and dislipidemias: usefulness of the dietary fiber LuraLean
usefulness of the dietary
Rodoriuez de Roa, Elsy et al., Jose Ignacio Baldo Hospital, Vargas Hopital, Gastroenterology Department Risk Factors Condulation (Unpublished Study)
Subjects
31 children & adolescents of age 9‐19 years (4 men & 27 women – average age: 15.2)
Methods
8
8‐Week
Week Placebo Controlled
Placebo Controlled Study
‐ LuraLean Group: 1 g (0.035 oz) / day of LuaraLean 3 times a day at the meals
‐ Placebo Group
ingestion was not decreased
not decreased during the study
the study
‐ Caloric ingestion was
Results
‐ Weight decrease (4.29 kg)
‐ BMI decrease (1.89 units)
‐ Waist diameter decrease (2.75 cm)
(2 75 cm)
‐ Cholesterol decrease (10.5 %)
‐ Triglycerides decrease (25.4 %)
‐ Fasting Glycemia decrease (9.8)
« The obtained results allow to recommend the use of … LuraLean in « obese and dislipidemic children and adolescents. » »
Results
Weight Loss After 8 Weeks of LuraLean supplementation 3 times a day
Weight Loss After 8 Weeks of LuraLean supplementation
3 times a day
Weight index of Body Mas
ss
(Variatio n Percentage)
0
1
-1
-0.77
0 77
-0.77
-2
-3
-4
LuraLean
Placebo
-4.29
4 29
-5
-6
-7
-6.5
Body Weight
BMI
Significant Improvements
Published Clinical Study 6: LuraLean improves Glycemia and Other Associated Risk Factors for Coronary Hear Disease in T
Type 2 Diabetes
2 Di b t
Vladimir Vuksan, David J.A. Jenkins et al., Diabetes Care, Vol 22, No.6: 913-919, 1999
Subjects
11 hyperlipidemic and hypertensive type 2 diabetic patients (5 men & 6 women – average age: 62 for men & 59 for women)
Methods
Double‐blind placebo control study for 8 weeks (3 weeks; 2 weeks washout; 3 weeks)
‐ Active: instructed to eat Biscuits (0.7 g/100 kcal, Stralean) 3 times a day as a snack with an 8‐oz beverage
‐ Placebo: instructed to eat Biscuits (14 g/day placebo fiber) 3 times a day as a snack with an 8‐oz beverage
‐ NCEP Step 2 diet provided with 3 meals provided under metabolic conditions
Measurements
‐ Cholesterol
‐ Triglycerides
‐ Glycemic levels
29
Results Cholesterol and Triglycerides improvement after 3 Weeks of LuraLean Biscuit Supplementation 3 times a day
Supplementation 3 times a day
10
0
9.58
5
2.1
0
-1.5
Glucose
Insulin
-5
-10
-11
-15
3 weeks
k
Placebo
3 weeks
k
LuraLean
L
LuraLean
L
Change in Ch
holesterol and
Triglycerides (mmol/l) % vs
cebo
Plac
Glucose (mmo
ol/l) and Insulin
(pmol/l) % vs Placebo
0.7 g LuaraLean/100 kcal biscuits
-5
-3
-3
Total Cholesterol
-4.9 -4.8
-10
LDL Cholesterol
-15
ApoB/ApoA-1
ration
-14
-8.6
-16
ApoB
-20
-25
-25
25
3 weeks
Placebo
3 weeks
LuraLean
LuraLean
Significant Well‐balanced Improvements
Clinical Study 7: Glycemic Level Control
Clinical Study 7: Glycemic
K. Doi, Lancet, p 987-988, May 1979 WPM Hopman et al., Gut, 198, 29 930-934
Significant Reduction of Glucose Levels after administration of LuraLean
Eff t f St l
Effect of Stralean on Urinary Excretion
Ui
E
ti
Significant decrease in Urinary / Glucose Excretion
Individual Percentage
g Change In Fasting
g
g Blood‐Glucose Levels
of 13 Diabetics After Administration
Decrease in Fasting Blood Glucose by 29 % in 30 Days
31
Clinical Study 7: Glycemic Level Control
Clinical Study 7: Glycemic
Changes of postprandial blood glucose after standard breakfast* with butter with or without LuraLean
Plasm
ma glucose (mmol/l)
Changes of postprandial blood glucose and serum insulin levels in normal subjects after test meals
l with
ith or without
ith t LuraLean
L L
* Breakfast (3 slices of bread, 20 g butter ‐ with or without Stralean – 42 g marmelade, 10 g sugar, 100 ml tea and 150 ml milk) 88 g carbohydrates, 18.5 g fat and 11 g proteins
32
Clinical Study 8: Major determinants of Plasma Glucose‐flattening activity
of a Water‐soluble Dietary Fiber: Effects of LuraLean on Gastric Emptying
and Intralminar Glucose‐Diffusion
and Intralminar
Glucose Diffusion
K.Ebihara et al., Nutrition Reports International June 1981, 23 No.6
LuraLeanPropol Mannan
Published Clinical Study 9:
Action of LuraLean on complaints inpatients affected with
chronic
h i constipation: a multicentricclinical
ti ti
lti t i li i l evaluation
l ti
S.Passaretti, M. Franzoni, U. Comin, R. Donzelli et al. Italian Journal of Gastroenterol 1991; 23:pp 421-425
Subjects
S bj t
93 patients with
different
93
i
i h chromic
h
i constipation (6+ months) i i (6
h ) 10 eachh from
f
d ff
hospitals – average age: 41.2, height:165 cm, weight: 62.6 kg
Methods
0.5 g x 2 capsules 2 times a day for 1 month.
Non‐controlled, open study
Non controlled open study
3 g / day for the 1st month, 2 g / day for the 2nd month
Measurements
‐ Bowel movements
‐ Number of enemas performed
Number of enemas performed
‐ Difficulty in evacuation and consistency of the stools
Objective evaluation in « Visual Analogue Scale »
Results
The treatment with Propol Mannan improved
p
p
all clinicallyy evaluated subjective and j
objective parameters.
Average number of days per week with at least one bowel movement increased from 1.0 to 4 within the first month, and the enemas reduced from 1.8 to 0.4.
These results seem much more important if it
more important if it is considered that many
that many patients were
patients were
affected with a long‐term stypsis and unresponsive to previous treatmants. Another
remarkable result was the persistence of subjective and clinical improvement even during
the maintenance phase, when the Propol Mannan was given at a reduced dose.
Results
Improved bowel movement for Severely Constipated Patients after 1 month of LuraLean Supplementation
LuraLean Supplementation
2-3 times a day
4
4
35
3.5
P er Week
3
2.5
2
1.9
Before Trials
LuraLean
1.8
15
1.5
1
0.5
0
0.4
Bowel movement
Enemas
Significant Improvements
Registration status
Patented in 33 countries, extensive throughout the world
Key competitive
advantages
Key competitive advantages (1)
y
p
g ( )
•
Effective fat & weight loss – support ingredient
Proven by more than 100 worldwide clinical studies including:
–
–
–
–
–
–
–
Weight reduction
Body fat reduction
Cholesterol control
g control
Blood sugar
Probiotics
Immune enhancement
Constipation
Health claims related to glucomannan confirmed
f
by EFSA
S in 2010
•
Safe compound
Proven by 14 strict pharmaceutical level complete safety studies including:
–
–
–
Dose-response study
Toxicity study
Acute toxicity study
Generally Recognized As Safe (GRAS) approved
Key competitive advantages (2)
•
100% natural- vegan friendly
•
P t t d technology:
Patented
t h l
– 3-stage purification process (high specialization)
– Patented manufacturing (33 countries)
– Other applications & technologies patented as well (USA, EU, Japon & Central/South
America)
•
Stable product:
– High temperature tolerance
– Salt, sugar & pH stable
– Non-binding with minerals & vitamins
•
High Quality Standards of the raw material & the manufacturing process
– The specific
p
species
p
((Amorphophallus
p p
Propol)
p ) that deliver the functionalityy of LuraLean have
b
been
d t
determined
i d 1st in
i th
the world
ld iin 1976
– Strong Expertise & Experience of the manufacturer
– Establishment of the mass-growing method & selection of know-how in order to deliver the
condensed pure quality substance
LuraLean comparison with other fibers
LuraLean comparison with other fibers Name of fiber
Natural origin
Inulin
Metilcelulose
Wheat fiber
Indigestible dextrin
Polycarbophil
calcium
LuraLean
(propolmannan)
(p
p
)
Yes
No
Yes
No
No
Yes
30‐35
58
20
16
/
3
Potential source of fiber in diet No significant results in loss weight No specific differences than in food without f d ith t
wheat fiber No improvement in blood glucose level /
See presentation Daly dose of clinical study (g)
Results of
R lt f studies t di
Smell and taste
Specific
Acceptable
Acceptable
Acceptable
Acceptable
Without
15 times
3‐4 times
10 times
3 times
60 times
More than 200 times
Real daily input of fiber with water (g)
60
12‐16
40
12
240
600
Percentage of fiber soluble
/
/
/
/
/
100%
Halal certification
/
/
/
/
/
Yes
Kosher certification
No
/
/
/
/
Yes
Vegetarian statute
No
/
/
/
/
Yes
Allergens presence
/
/
/
/
/
No
Reduction of flatulence
No
Yes
No
No
Yes
Yes
Less than 1 cal/ dose
No
No
No
No
Yes
Yes
Capacity of water p
absorption