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Agenda• Welcome and Thank You!
• Setting the Stage
• Cholesterol and heart health
• The challenge
• The natural solution
• Sytrinol proven benefits
Sytrinol® Condition Specific Strategy
• Heart Health
• Eye Health
• Joint Health
• Sports Performance
SourceOne’s strategic approach to the market focuses on product concepts that support specific aspects of human health.
• Weight Loss
• Metabolic Syndrome
• Type II Diabetes
Primary focus is to help our customers create formulations to address these health concerns and then market them creatively
Cardiovascular Health
• More than 64 million Americans have some form of CVD• Estimated 1 in 4 deaths in the US each year from heart
disease• Leading cause of death in the US each year since 1900• CVD will cost the nation over an estimated $386 billion in • High blood cholesterol is one of the major risk factors for
Heart Disease
Breaking News from the American Heart Association…
• The American Heart Association’s new guidelines for preventing CVD in women includes a strong recommendation that high-risk women, even those with an LDL cholesterol level below 100, should receive cholesterol-lowering statin drugs
• In 2012, 56 percent of women identified heart disease as the leading cause of death compared with 30 percent in 1997
Recommendations endorsed by: • National Heart, Lung and Blood Institute• American Heart Association • American College of Cardiology
“Experts Set a Lower Low for Cholesterol Levels”
The new guidelines are also expected to TRIPLE the number of people prescribed a cholesterol lowering drug - from 15
million to more than 36 million!
Six of nine panel members drafting new guideline are associatedwith companies that manufacture statins
New NCEP-ATP III (2001)*Earlier NCEP-ATP II (1993)*
High≥60
Low<40Optimal>35HDL-cholesterol
High≥240>260
Borderline200-239Borderline220-260
Desirable<200Optimal<220Total cholesterol
Very High≥190
High160-189
Borderline130-159High>160
Near optimal
100-129Borderline130-159
Optimal<100Optimal<130LDL-cholesterol
New NCEP-ATP III (2001)*Earlier NCEP-ATP II (1993)*
High≥60
Low<40Optimal>35HDL-cholesterol
High≥240>260
Borderline200-239Borderline220-260
Desirable<200Optimal<220Total cholesterol
Very High≥190
High160-189
Borderline130-159High>160
Near optimal
100-129Borderline130-159
Optimal<100Optimal<130LDL-cholesterol
Cholesterol-lowering Options
• New NCEP guidelines expected to raise the number of people on dietary treatment from about 52 million to about 65 million.
• The guidelines are also expected to TRIPLE the number of people prescribed a cholesterol lowering drug - from 15 million to 36 million.
• More aggressive cholesterol-lowering treatment• Better identification of those at high risk for a heart attack• Use of a lipoprotein profile as the first test for high cholesterol• A new level at which low HDL becomes a major heart disease risk factor• A new set of Therapeutic Lifestyle Changes with more power to improve cholesterol levels
NCEP ATP III– Besides the new lipid numbers, what are other changes?
Third Report of the National Cholesterol Education Program (NCEP) Expert Panel
SytrinolNature’s Solution to the Cholesterol Problem
• A patented formula derived from natural citrus and palm fruit extracts.
• Combines polymethoxylated flavones (PMFs) & palm alpha, delta, and gamma tocotrienols, and other proprietary constituents.
• Supported by multiple clinical studies• Efficacious dose is 300mg per day
Orange, Tangerine Peels Could Be Better Than Drugs For Lowering Cholesterol
Journal of Agricultural and Food Chemistry, May 2004
The most common of these super-flavonoids tangeretin and nobiletin - exist in orange and tangerine peels. Easier way to lower cholesterolThan drinking 20 or more cups of orange juice daily
“A joint study by the U.S. Department of Agriculture and KGK Synergize, identified a class of compounds isolated from orange and tangerine peels that shows promise in animal studies as a potent, natural alternative for lowering LDL cholesterol (bad cholesterol), without the possible side effects, such as liver disease and muscle weakness, of conventional cholesterol-lowering drugs.”
Sytrinol Animal Study• Male Golden Syrian Hamsters, initial body weight 100-120g• Control and experimental diets for 35 days• Treatments included Sytrinol, PMF, Tocotrienol, others• Serum analyzed for lipid responses
TC – Total CholesterolLDL – LDL CholesterolTG – Total Triglyceride
TC LDL TG
% c
han
ge f
rom
B
asel
ine
to 5
-wee
ks
-80%
-70%
-60%-50%
-40%
-30%
-20%
-10%
0%
-50% -59% -57%
* * *
* P 0.05
Kurowska et al., 2004
4-week clinical results
-35%
-30%
-25%
-20%
-15%
-10%
-5%
0%TC LDL TG LDL / HDL
I ΙΙ ΙΙΙ I ΙΙ ΙΙΙ I ΙΙ ΙΙΙ I ΙΙ ΙΙΙ
Multiple Clinical Study Summary
% r
edu
ctio
n
Effect on Total Cholesterol
BASELINE 4 WEEK 8 WEEK 12 WEEK
-29% -28% -30%
200
210
220
230
240
250
260
270
280
290
300
-29% -28% -30%
PLACEBO/SYTRINOL
* **
mg/
dL * P 0.05
* Published in Alternative Therapies for Health and Medicine
150
160
170
180
190
200
210
Effect on LDL Cholesterol
BASELINE 4 WEEK 8 WEEK 12 WEEK
-25% -25% -27%
* **
mg/
dL
PLACEBO/SYTRINOL
* P 0.05
* Published in Alternative Therapies for Health and Medicine
Effect on Total Triglyceridem
g/dL
60
70
80
90
100
110
120
BASELINE 4 WEEK 8 WEEK 12 WEEK
-30% -35% -34%
* **
PLACEBO/SYTRINOL
* P 0.05
* Published in Alternative Therapies for Health and Medicine
3
3.5
4
4.5
5
LDL/HDL
BASELINE 4 WEEK 8 WEEK 12 WEEK
-30% -28% -29%
* **
PLACEBO/SYTRINOL
Rat
io o
f L
DL
:HD
L
* Published in Alternative Therapies for Health and Medicine
Heart Protection Matrix
LDL benefits (PMFs)•Reduced ApoB => Reduced LDL synth.•Reduced MTTP => Reduced LDL synth.
MTTP = microsomal triglyceride transer protein; DGAT = diacylglycerol acteyl transferasePPAR = peroxisome proliferator-activated receptor; HMGCAR = HMGCoA Reductase
Antioxidant benefits (both)
Anti-inflammatory benefits(PMFs)
TC benefits (Tocotrienols)•Increased HMGCAR degradation => Reduced TC synth.
Triglyceride benefits (PMFs)•Reduced DGAT => Reduced TG synth.
•Increased liver PPAR => Increased FA oxid.
Fatty acids Triglycerides
DGAT
LDL Lipoprotein Assembly
Fatty Acids TriglyceridesX
Triglycerides Nascent apo B
MTP
X
Kurowska et al.,2004
ß-oxPPARFatty acids
PMF Mechanism
ACETYL COA
HMG-CoA Reductase
GERANYL GERANIO
GERANIOL
FARNESOL
PROTEINS CoQ10
CHOLESTEROL
CHOLESTEROLSYNTHESIS
CoQ10 ↓ by statinMay lead to ↓ energy
Protein ↓ by statinMay lead to myopathy
STATIN
X
TOCOTRIENOL
(Targets Farnesol)
Down RegulatesHMGCR
HMGCR-INCREASE RATEOF NATURALDEGRADATION
HMG-CoA REDUCTASE
Sytrinol as the Superior Product
Sytrinol vs. Guggulipids• Journal of the American Medical Association states that
consuming guggulipids does not have any significant effect on lowering cholesterol.
• Studies have shown guggulipids to actually raise levels of LDL cholesterol.
• University of Kansas found that guggulsterone, the active ingredient in guggulipid, may interfere with nearly 60% of prescribed drugs, ironically enough, including anti-cholesterol statin drugs.
• Mayo Clinic Health Letter and John Hopkins Med Letter reported guggulipids were not effective for lowering cholesterol.
Guggulipids vs.
Reduces Arterial Plaque NO Reduces Inflammation NO Strong Antioxidant Activity NO Continued investement in clinical research
NO Researched ingredient available to consumer
Varies % TC reduced 12% 30%
% LDL reduced 13% 27%
%TG reduced 12% 34%
% HDL increased None Reported 4%
Potency used in trials2,000-6,000 mg Guggul 50-
150mg Guggulsterones 300 mg
Dosage recommended in supplements
600 mg Guggul 12.5mg Guggulsterones 300mg /day
Guggulipids vs.
Mechanisms of Action
Inhibition of cholesterol biosynthesis, enhancement rate
of cholesterol extraction and promotion of degradation of
cholesterol
Inhibits HMG-COA reductase, decreases Apo protein B needed for LDL synthesis,
decreases activity DGAT, enzyme needed for TG synthesis
Adverse Side Effects Reported Headache, nausea, skin rash None Reported. Well Tolerated
Drug InteractionsUniversity of Kansas reports it
interacts with 60% of prescription drugs
None Reported. Well Tolerated
Sytrinol vs. Policosanol• No clinical trials supporting the efficacy of policosanol
outside of Cuba• Journal of American Medical Association finds no
evidence of a lipid-lowering benefit with policosanol.• “The evidence base supporting policosanol has eroded
dramatically since its global birth at the turn of the 21st century. The ostensible promise and the eventual disappointment underscore the need for independent RCTs, and for multi-ethnic interventions.” - Anthony Almada MSc
Policosanol vs.
Reduces Arterial Plaque NO Reduces Inflammation NO Strong Antioxidant Activity
NO Continued investement in clinical research
NO Researched ingredient available to consumer
NO % TC reduced 16% 30%
% LDL reduced 10-20% 27%
%TG reduced Minimal Effect 34%
% HDL increased 5-25% 4%
Potency used in trials 10-40 mg 300 mg
Dosage recommended in supplements
10-40 mg/day 300mg /day
Mechanisms of Action No agreement on mechanism of action
Inhibits HMG-COA reductase, decreases Apo protein B needed for
LDL synthesis, decreases activity DGAT, enzyme needed for TG
synthesis
Adverse Side Effects Reported
Weight loss, frequent urination, headache, dizziness, others None Reported. Well Tolerated
Drug InteractionsDo not mix well with blood thinning
medications or aspirin None Reported. Well Tolerated
Policosanol vs.
Sytrinol vs. Plant Sterols
• Plant sterols do not reduce arterial plaque or inflammation.
• Plant sterols cannot be used for strong antioxidant activity.
• Plant sterols have no effect on triglyceride levels or HDL levels.
Plant Sterols vs.
Reduces Arterial Plaque NO Reduces Inflammation NO Strong Antioxidant Activity NO Continued investement in clinical research
NO Researched ingredient available to consumer % TC reduced 8-15% 30%
% LDL reduced 8-15% 27%
%TG reduced NO 34%
% HDL increased NO 4%
Potency used in trials 800-3,000mg 300 mg
Dosage recommended in supplements
800-1800mg 300mg /day
Plant Sterols vs.
Mechanisms of ActionBlock food based cholesterol from being absorbed into the
bloodstream
Inhibits HMG-COA reductase, decreases Apo protein B needed for
LDL synthesis, decreases activity DGAT, enzyme needed for TG
synthesis
Adverse Side Effects Reported
No knows drug or nutrient reactions, some GI upset in
one studyNone Reported. Well Tolerated
Drug Interactions None None Reported. Well Tolerated