Note: Descriptions are shown in the official language in which they were submitted.
CA 02595096 2007-07-27
Title
HERBAL PRODUCT COMPRISING CINNAMON AND CHOCOLATE
Field of the Invention
[0001] This invention relates to a new herbal product and in particular, to a
new herbal
product comprising cinnamon (Cinnamomi cassiae: Cinnamonum verum) and
chocolate. Each
of these ingredients is known to demonstrate therapeutic effects but the
combination of the two
ingredients demonstrates significant synergism and improved therapeutic
effects.
Background of the Invention
[0002] Diabetes, hyperlipidemis and obesity, besides being detrimental to
health by
themselves, are all recognized risk factors for cardiovascular disease (CVD),
which is still the
number one killer in North America. Obesity is reaching epidemic proportions
in N. America
and Type 2 diabetes, with its close links to obesity, has become a major cause
for concern. High
blood cholesterol levels have persisted as a key factor in the development of
atherosclerosis and
CVD, and high triglycerides have also been recognized as an important risk
factor, especially for
women. The incidence of metabolic syndrome (also known as insulin resistance
syndrome, or
syndrome X), which presents as a cluster of characteristics and symptoms,
including obesity,
increased waist circumference, borderline high blood glucose and blood
pressure levels, and
abnormal blood lipid levels, has been increasing sharply since it was first
recognised as a
common precursor to both CVD and diabetes.
[0003] While modern pharmaceutical drugs exist for the treatment of
hyperlipidemia,
diabetes, and CVD, the side effects associated with many of these drugs may
have severely
detrimental health effects which preclude their use, or these side effects may
simply reduces
patient compliance. As a result, a majority of the population has been looking
elsewhere for the
treatment of these diseases and conditions, and complementary therapies have
become a popular
alternative to the pharmaceutical model for treatment.
[0004] A herbal product which is a likely candidate as a treatment option is
cinnamon
(Cinnamomi cassiae; Cinnamomum verum).
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[0005] Cinnamon has been widely used for centuries, and is a traditional folk
herb for
diabetes mellitus in Russia, China and Korea. It is also thought to possess
anti-fever and
antibiotic properties, as well as being as mild analgesic and sedative. Recent
research has
focused on its ability to lower blood glucose levels. In recent animal
studies, its blood-glucose-
lowering ability was dose-dependent, with higher doses lowering glucose levels
more than lower
doses. Insulin levels increased, as did HDL cholesterol levels (the so-called
"good" cholesterol).
Total and LDL cholesterol levels and triglyceride levels, on the other hand,
were reduced with
cinnamon supplementation. An additional benefit of cinnamon supplementation
may be its
antioxidant capacity, due to its phenolic acids and flavonoids. This
antioxidant capacity may not
only slow the progression of Type 2 diabetes complications, by quenching the
excessive oxygen
free radical damage seen in diabetes, it may also protect LDL cholesterol from
oxidation,
reducing the likelihood of it being scavenged and incorporated into blood
vessel wall plaque, the
latter being a major part of atherosclerosis, hypertension and CVD.
[0006] Cocoa and chocolate have recently been found to be rich plant-derived
sources of
antioxidant flavonoids with beneficial cardiovascular properties. These
favourable physiological
effects include: antioxidant activity, vasodilation and blood pressure
reduction, inhibition of
platelet activity, and decreased inflammation. Increasing evidence from
experimental and
clinical studies using cocoa-derived products and chocolate suggest an
important role for these
high-flavanol-containing foods in heart and vascular protection.
[0007] Accordingly, the present inventors have combined these two basic
ingredients into a
single therapeutic formulation which demonstrates synergistic results. The
inventors have found
that the new therapeutic formulation has resulted in the following:
1. Reduction in blood glucose levels and increased glucose tolerance in
diabetics and people
with metabolic syndrome.
2. Reduction in total and LDL cholesterol and triglycerides, and increase in
HDL cholesterol in
people with dyslipidemia, including people with metabolic syndrome.
3. Reduction in obesity.
4. Improved antioxidant capacity, with the potential to protect diabetics
against free radical
damage, and to reduce oxidized LDL cholesterol levels.
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[0008] Thus, this new therapeutic formulation may be used to treat diabetes
and CVD, and
also in the precursor syndrome, where almost all of the characteristics of
this syndrome - high
total and LDL cholesterol, high triglyceride, low HDL cholesterol, borderline
high blood glucose
levels, obesity and high waist circumference - may be improved. Even
borderline high blood
pressure, which is normally affected by the degree of obesity, may be reduced.
In effect, this
therapeutic formulation will reduce the incidence of metabolic syndrome,
which, in turn, would
reduce the incidence of diabetes, CVD and obesity. This is the first herbal
combination with the
potential to have more significant effects than pharmaceutical drugs on this
triumvirate of
conditions which continues to have a major impact on the health of North
Americans.
Summary of the Invention
[0009] To this end, in one of its aspects, the present invention provides a
novel therapeutic
formulation which comprises cinnamon and chocolate.
[0010] A further object of the present invention is to provide a new
therapeutic formulation
which comprises cinnamon and chocolate in a ratio of about 1:5 to about 1:10.
Preferably, the
ratio is about 1:8.
[0011] A still further object of the invention is to provide a new therapeutic
product which
provides between about 250 milligrams to about 12,000 milligrams of cinnamon
powder per day
admixed in a vehicle of chocolate containing about 40 grams to about 50 grams
of chocolate.
[0012] A still further object of the invention is to provide a new therapeutic
product which
provides between about 3000 milligrams to about 6000 milligrams of cinnamon
powder per day
admixed in a vehicle of chocolate containing about 40 grams to about 50 grams
of chocolate.
[0013] A still yet further object of the present invention is to provide a new
therapeutic
product which contains between 250 milligrams to about 12,000 milligrams of
cinnamon powder
mixed in a chocolate bar containing about 40 grams to 50 grams of chocolate.
[0014] A still yet further object of the present invention is to provide a new
therapeutic
product which contains between about 3000 milligrams to about 6000 milligrams
of cinnamon
powder mixed in a chocolate bar containing about 40 grams to 50 grams of
chocolate.
[0015] A still further object of the present invention is to provide a novel
chocolate bar
containing 43 grams of chocolate and 5000 milligrams of cinnamon powder for
daily ingestion.
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Detailed Description of the Invention
[0016] The two active ingredients of the new therapeutic formulation are
cinnamon and
chocolate.
[0017] In recent years numerous laboratory and clinical studies have been
conducted on
cinnamon by biological scientists, pharmacologists and pharmacists at
prestigious research
centres like Department of Pharmacy at the Kings College of London, University
of Califoinia,
Santa Barbara, Iowa State University and the U.S. Department of Agriculture.
All of these
studies show findings that confirm the therapeutic properties of cinnamon
claimed by the
traditional medicine and some of the research actually is considered to be
break through in the
field of natural health products. At USDA, scientists have been able to
identify the particular
molecule in cinnamon that mimics insulin and is responsible for its
hypoglycaemic properties.
[0018] The new therapeutic formulation contains cinnamon and chocolate at a
ratio of 1:8
which is the most synergistic combination of the two ingredients for the
management of blood
sugar levels of type 2 diabetes patients as well as for normalizing the lipid
profiles.
[0019] The dietary habits of the developed countries such as Canada and United
States have
recently been criticized for causing an increase in the incidence of several
types of lifestyle-
related diseases such as diabetes, obesity and cardiovascular diseases.
Diabetes, a disorder of
carbohydrate, fat and protein metabolism attributed to diminished production
of insulin or
mounting resistance to its action, is the most common metabolic disease
presently. It is a major
cause of disability and hospitalization resulting in a significant financial
burden on the health
care system (Rathi et al. 2002 and Virdi et al. 2003), and is estimated to
cost Canadians up to $9
billion annually (Public Health Agency of Canada, 2005). It also has a
significant impact on the
health, quality of life and life expectancy of patients. Diabetes is a potent
risk factor for
cardiovascular disease as it not only affecting glucose metabolism but also
influences lipid
metabolism (Jayasooriya et al. 2000). Diabetes is divided into two major
categories: type 1
diabetes, previously known as insulin dependent diabetes mellitus (IDDM), and
type 2 diabetes,
previously known as non-insulin dependent diabetes mellitus (NIDDM). Although
the
recommended treatments for these two categories are usually somewhat
different, insulin for
IDDM and lifestyle management for NIDDM, the overall result is improving
glucose
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homeostasis. Lifestyle management such as changes in diet and an exercise
regimen continues
to be essential and effective but it may be insufficient or difficult for
patient compliance
rendering conventional drug therapies useful (Dey et al. 2002). The problems
with the use of
insulin or any other antidiabetic drugs are the presence of adverse effects
such as hypoglycemia
at higher doses, liver problems, lactic acidosis and diarrhea (Virdi et al.
2003). In recent years,
there has been a growing interest in herbal medicines specifically herbal
extracts as a popular
alternative in healthcare due to people's perception of it being a`natural'
product and therefore a
minimal chance of having any side effects. The current popularity is also due
to the many
botanicals reported for the management of diabetes in other alternative
systems of medicine such
as Ayurveda and Traditional Chinese Medicine, the interest in these herbal
plants has been
piqued.
[0020] The following is a brief description of the two ingredients and their
therapeutic
properties.
[0021] Cinnamomum aromaticum (sp. Cassia) is from the family Lauraceae. It is
a medium-
sized evergreen tree native to China and Vietnam. It contains volatile oils
composed of
cinnamaldehyde, phenolic compounds, flavonoid derivates, methylhydroxychalcone
polymer,
mucilage, calcium oxalate, resins, sugars, and coumarins. Cassia, the species
name for
Cinnamomum aromaticum comes from the Greek work "kassia" meaning "to strip off
the bark".
Cinnamon bark has been used medicinally in China since 2700 B.C.E and is said
to supplement
vital energy and blood, tone the kidney and spleen and acts as an antioxidant
(Blumenthal et al.
1998). Cinnamomum aromaticum has also been used in Korea, China and Russia as
a traditional
folk herb with hypoglycemic properties for the treatment of diabetes mellitus
(Kim et al. 2005).
[0022] The increasing prevalence of diabetes and cardiovascular disease is
evident
worldwide with an estimated 1700 new cases diagnosed daily (Jarvill-Taylor et
al. 2001).
Additionally, several million people worldwide are suffering from `pre-
diabetes' caused by high
glucose levels with a resistance to insulin (Khan et al. 2003). The primary
function of insulin is
to maintain low blood glucose, lipid and cholesterol levels to maintain a
sense of well-being.
Environmental factors such as diet, exercise, and stress also attribute to
decreasing insulin
sensitivity and increasing glucose and low-density lipoprotein (LDL)
cholesterol levels,
increasing the risk of cardiovascular diseases, obesity, dyslipidemias,
diabetes mellitus and
premature aging. The increase in disease is partly due to the augmented intake
of calories and
CA 02595096 2007-07-27
refined carbohydrates, lesser consumption of fibers and a more sedentary
lifestyle. Controlling
dietary intake and exercise could prevent disease but the majority of
individuals require an extra
aid to maintain normal health (Talpur et al., 2005). There is a growing
interest in herbal
remedies due to the side effects associated with therapeutic hypoglycemic
agents and insulin
(Kim et al. 2005). Botanical products with a long history of safety are widely
used to lower
glucose, lipid and cholesterol levels and for the prevention and treatment of
diabetes.
[0023] Cinnamomum aromaticum has been used as a hypoglycemic agent in ancient
medicines (Kim et al. 2005). The modem therapeutic properties of cinnamon are
supportable
based on thousands of years of use in well established systems of traditional
medicines, as well
as some modem clinical studies (Blumenthal et al. 1998). A number of well
proven in vivo
animal studies on Cinnamomum aromaticum demonstrate that activation of the
insulin receptor
increases autophosphorylation resulting in an increase in glucose uptake and
glycogen synthesis.
However, there is a limited amount of published data on the effects of
cinnamon consumption on
blood glucose in humans. In vivo, in vitro and human studies have established
that cinnamon
extract regulates insulin activity and reduces serum glucose and cholesterol
levels (Khan et al.
2003 and Kim et al. 2005).
[0024] In a study by Khan et al. in 2003, 60 men and women with type 2
diabetes ingested
daily doses of cinnamon or placebo capsules for 40 days followed by a 20-day
washout period.
Cinnamon capsules contained 1, 3 or 6 g of Cinnamomum aromaticum. After 20
days, only the
6 g cinnamon group showed significantly lower glucose levels. However, after
40 days, serum
glucose (18-29%), triglycerides (23-30%) and total cholesterol (12-26%)
concentrations were
significantly lower in all cinnamon groups. Total cholesterol was lower in all
groups at 40 days
but low-density lipoprotein (LDL) concentrations were only significantly lower
in the 3 g and 6
g cinnamon groups (10% and 24%, respectively). For the 1 g cinnamon group, LDL
concentrations continued to decline during the washout period and were
significant at 60 days
(P<0.05). The decreased concentration of glucose was maintained by the 1 g
cinnamon group
while triglyceride and total cholesterol levels were maintained in all
cinnamon groups throughout
the 20-day washout period.
[0025] Vanschoonbeek et al. 2006 performed a 6 week standardized placebo-
controlled
study to investigate the proposed benefits of Cinnamomum cassia on 25
postmenopausal women
diagnosed with type 2 diabetes. Patients were divided into two groups and
supplemented with
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1.5 g/day of Cinnamomum or placebo to assess the effects on glucose tolerance
and whole-body
insulin sensitivity. At 0, 2 and 6 weeks oral glucose tolerance tests and
blood lipid profiles were
performed resulting in no time x treatment interaction observed for fasting
glucose, insulin
concentration, insulin resistance, (oral glucose) insulin sensitivity or
fasting blood lipid
concentrations. This study shows cinnamon supplementation does not have a
health benefit in
patients with type 2 diabetes contradicting the results found by Khan et al.
2003. Differences
between the two studies could be attributed to the selection of patients and
the combination of
medications taken. In the current study, only postmenopausal female patients
were included and
continued using commonly prescribed combinations of oral blood glucose-
lowering agents,
which was not a factor in the study by Khan et al. 2003, explaining the low
baseline values found
in the patients used in the current study. Although the authors concluded
cinnamon
supplementation in combination with oral blood glucose-lowering agents may not
be beneficial
to overweight, postmenopausal women, this is a small concentrated study not
factoring in the use
of other medications and patient characteristics.
[0026] In a study by Talpur et al. in 2005, Zucker fatty rats (ZFRs) and
spontaneously hyper-
tensive rats (SHRs) were fed water or essential oils in acute or chronic doses
to assess the effect
of essential oil combinations on insulin sensitivity. The essential oil
treatment consisted of 8
essential oils including cinnamon. Insulin sensitivity was determined by
systolic blood pressure
(SBP) and a glucose tolerance test. In the acute study, ZFRs and SHRs with
essential oil
treatments showed significant decreases in SBP at 4, 10 and 20 hours and at 4
hours,
respectively. However, SBP levels were equal to the control group at 30 hours
in ZFRs and at
10, 20 and 30 hours in SHRs. In the chronic study, ZFRs and SHRs consuming the
essential oils
showed significantly lower SBP at 8, 17 and 25 days in comparison to the
control group.
Decreases in SBP levels ranged from 11 to 20 mmHg. During the oral glucose
test, ZFRs
consuming the essential oil combination showed consistently lower levels of
circulating insulin,
however these results were not significant. SHRs did not produce any effect on
insulin levels
and were equal to the controls, paralleling previous studies where effects
were only produced
when rats were challenged in stress-free environments (Verspohl et al. 2005).
The decreases in
SBP and circulating glucose levels, produced by both species of rats, enhance
insulin sensitivity
and parallels the idea that fluctuating SBP is the most sensitive index of
insulin sensitivity.
Cinnamon has been shown to have insulin-like actions and affect insulin
signaling (Broadhurst et
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al. 2000), and as an ingredient in the essential oil combination it may have a
role in the reduction
of SBP.
[0027] In another study, Kim et al. 2006, administered db/db mice Cinnamomum
cassia
dosages of 50, 100, 150 or 200 mg/kg for 6 weeks to determine its effect on
blood glucose. The
control group showed high blood glucose levels at 2, 4, and 6 weeks. The
cinnamon extract-
treated group showed significantly lower blood glucose levels at each time
period (P<0.05, <0.01
and <0.001). Significant decreases in triglyceride and total cholesterol
levels were noted in the
cinnamon extract group. Similar to Khan et al. 2003 these results parallel the
hypoglycemic
effects in the cinnamon extract-treated group as reduced levels are maintained
for a long period
of time.
[0028] In a similar study by Verspohl et al. in 2005, blood glucose and plasma
insulin levels
were evaluated in Wistar rats given extracts of Cinnamomum bark, cassia or
zeylanicum. During
the glucose tolerance test, plasma insulin levels increased significantly
after the administration of
Cinnamomum extracts with cassia showing the most pronounced effect. The saline
placebo
group showed no effect on plasma insulin. In all extract-treated groups, blood
glucose levels did
not decrease unless the rat was challenged by a glucose tolerance test in a
stress-free
environment. Cinnamomum cassia produced a direct insulin stimulatory effect
showing superior
effects compared to zeylanicum.
[0029] The increase in fructose consumption has risen worldwide in the past
two decades as
a significant proportion of energy intake in the diet. Qin et al. 2004 fed 18
male Wistar rats a
high-fructose diet and 6 a control diet for 3 weeks to determine the effects
of glucose utilization
and insulin sensitivity. 12 of the rats consuming a high-fructose diet had
Cinnamomum cassia
extracts (300 mg/kg/day) added to their diet. During the euglycemic clamp
procedure to
measure glucose infusion rates (GIR), the 6 rats consuming only a high-
fructose diet showed
significant decreases (p<0.0001) in glucose infusion rates while cinnamon
treated rats produced
significant increases, similar to the controls. The consumption of a high-
fructose diet, an
environmental factor contributing to diabetes, is common in the western
society; the addition of
Cinnamomum cassia extract to the diet shows a preventative effect, through an
increase in
glucose utilization and insulin sensitivity.
[0030] In another study, the effect of cinnamon extract on insulin action was
evaluated in
Wister rats. Qin et al. 2003 randomly assigned 18 rats into three groups:
saline, 30mg/kg and
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300mg/kg cinnamon extract. Cinnamon treatment for 3 weeks did not have an
effect on plasma
free fatty acids and fasting blood glucose concentrations. Although these
levels were not
affected in the cinnamon treated group, a difference was prevalent in glucose
uptake compared to
the placebo group. A dose-dependent manner was noticed with glucose
utilization as 300mg/kg
enhanced glucose utilization to a greater degree than the 30mg/kg or control
groups.
[0031] Methylhydroxychalcone polymer (MHCP), a bioactive compound of cinnamon
extract, is hypothesized to trigger an insulin-like response. In a study by
Jarvill-Taylor et al.
2001, 3T3-L1 adipocytes were assessed with MHCP to determine its function as
an insulin
mimetic. Within the first 10 minutes of incubation, the insulin treated
adipocytes showed a 2.5
fold increase in glucose transport while the MHCP treated group did not show
any increase.
However, gradually over the one-hour period, glucose uptake increased in the
MHCP treated
group and at 60 minutes, a significant increase was noted. As noted in other
studies, the effect of
cinnamon did not diminish immediately after stopping treatment. As MHCP is
administered, the
kinase receptor is activated resulting in phosphorylation of the insulin
receptor, a similar effect is
seen throughout the insulin signaling pathway.
[0032] A similar study by Broadhurst et al. in 2000 reported an increase in
insulin action
demonstrated by cinnamon extract in vitro. Rat epididymal adipocytes were
given either insulin
or cinnamon extract after incubation to determine glucose metabolism. At all
dilutions (1:2,
1:10, 1:50) cells exposed to cinnamon extract showed a significant increase in
insulin-dependent
activity and the effect was maintained at the high dilution (1:50). As
adipocytes were treated
with cinnamon extract the insulin receptor kinase became activated, a
necessary requirement to
increase insulin sensitivity. The activation of kinase mimics insulin activity
in adipocytes.
Afterwards, active cinnamon extract was incubated with soluble
polyvinylpyrrolidone (PVP) to
determine if activity was associated with tannins or polyphenols. Cinnamon
readily bound to
PVP giving it a polyphenolic characterization. With an increase in glucose
metabolism, 98% of
activity is attributed to PVP indicating the use of phenolics to destroy free
radicals that inhibit
the activation of insulin-receptor kinase. Cinnamon extract mimics the same
mechanism as
insulin in adipocytes, increasing insulin sensitivity and glucose metabolism.
[0033] Cinnamomum aromaticum (cinnamon) has convincingly been shown to prevent
and
control elevated glucose and blood lipid concentrations in both in vitro and
in vivo studies and
can be maintained for a long period after use. The insulin kinase receptor is
activated with
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cinnamon extract demonstrating insulin-mimetic activity. Elevated glucose and
blood lipid
concentrations increase the incidence of diabetes and/or cardiovascular
health. The use of
cinnamon extract can prevent these diseases by regulating the insulin receptor
to increase
glucose uptake and metabolism.
[0034] To date there have been no formal pharmacokinetic studies done on this
plant in
animals or humans. The only information derived from literature was a study
conducted by
Khan et al. in 2003 that found Cinnamomum aromaticum (extract) has a prolonged
effect on the
human body for 20 days during the washout period. Several animal studies have
also shown
prolonged effects after consumption of cinnamon extract.
[0035] The exact mechanism of action of Cinnamomum aromaticum (extract) is
thought to
be that it acts as an insulin-mimetic by activating the kinase receptor and
increasing insulin
sensitivity. The interaction within the intracellular kinase domain triggers
an insulin-like
response and stimulates glucose oxidation. Cinnamon also regulates enzymes
inside the insulin
receptor kinase domain and inhibits both phosphotyrosine-specific protein
phosphatase (PTP-1)
in vitro and glycogen synthase kinase-3 ^(GSK-3 ^) in vivo. The inhibition of
PTP-1 keeps the
insulin receptor in an activated state and inhibition of GSK-3 ^ stimulates
glycogen production.
Cinnamon acts independently from insulin but similar levels of activity were
observed proposing
that it may activate the same cascade as the insulin signaling pathways
(Jarvill-Taylor et al.
2001).
[0036] Cinnamon significantly helps people with type 2 diabetes improve their
ability to
respond to insulin, thus normalizing their blood sugar levels. Both test tube
and animal studies
have shown that compounds in cinnamon not only stimulate insulin receptors,
but also inhibit an
enzyme that inactivates them, thus significantly increasing cells' ability to
use glucose. Studies
to confirm cinnamon's beneficial actions in humans are currently underway with
the most recent
report coming from researchers from the US Agricultural Research Service, who
have shown
that less than half a teaspoon per day of cinnamon reduces blood sugar levels
in persons with
type 2 diabetes. Their study included 60 Pakistani volunteers with type 2
diabetes who were not
taking insulin. Subjects were divided into six groups. For 40 days, groups 1,
2 and 3 were given
1, 3, or 6 grams per day of cinnamon while groups 4, 5 and 6 received placebo
capsules. Even
the lowest amount of cinnamon, 1 gram per day (approximately'/4 to V2
teaspoon), produced an
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approximately 20% drop in blood sugar; cholesterol and triglycerides were
lowered as well.
When daily cinnamon was stopped, blood sugar levels began to increase.
[0037] Test tube, animal and human studies have all recently investigated
cinnamon's ability
to improve insulin activity, and thus our cells' ability to absorb and use
glucose from the blood.
[0038] Ongoing in vitro or test tube research conducted by Richard Anderson
and his
colleagues at the USDA Human Nutrition Research Center is providing new
understanding of
the mechanisms through which cinnamon enhances insulin activity. In their
latest paper,
published in the Journal ofAgricultural and Food Chemistry, Anderson et al.
characterize the
insulin-enhancing complexes in cinnamon-a collection of catechin/epicatechin
oligomers that
increase the body's insulin-dependent ability to use glucose roughly 20-fold..
Some scientists
had been concerned about potentially toxic effects of regularly consuming
cinnamon. This new
research shows that the potentially toxic compounds in cinnamon bark are found
primarily in the
lipid (fat) soluble fractions and are present only at very low levels in water
soluble cinnamon
extracts, which are the ones with the insulin-enhancing compounds.
[0039] A recent animal study demonstrating cinnamon's beneficial effects on
insulin activity
appeared in the December 2003 issue of Diabetes Research and Clinical
Practice. In this study,
when rats were given a daily dose of cinnamon (300 mg per kilogram of body
weight) for a 3
week period, their skeletal muscle was able to absorb 17% more blood sugar per
minute
compared to that of control rats, which had not received cinnamon, an increase
researchers
attributed to cinnamon's enhancement of the muscle cells' insulin-signaling
pathway. In humans
with type 2 diabetes, consuming as little as 1 gram of cinnamon per day was
found to reduce
blood sugar, triglycerides, LDL (bad) cholesterol, and total cholesterol, in a
study published in
the December 2003 issue of Diabetes Care. The placebo-controlled study
evaluated 60 people
with type 2 diabetes (30 men and 30 women ranging in age from 44 to 58 years)
who were
divided into 6 groups. Groups 1, 2, and 3 were given 1, 3, or 6 grams of
cinnamon daily, while
groups 4, 5, and 6 received 1, 3 or 6 grams of placebo. After 40 days, all
three levels of
cinnamon reduced blood sugar levels by 18-29%, triglycerides 23-30%, LDL
cholesterol 7-27%,
and total cholesterol 12-26%, while no significant changes were seen in those
groups receiving
placebo. The researchers' conclusion: including cinnamon in the diet of people
with type 2
diabetes will reduce risk factors associated with diabetes and cardiovascular
diseases.(January
28, 2004)
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[0040] The latest research on cinnamon shows that by enhancing insulin
signaling, cinnamon
can prevent insulin resistance even in animals fed a high-fructose diet! A
study published in the
February 2004 issue of Hormone Metabolism Research showed that when rats fed a
high-
fructose diet were also given cinnamon extract, their ability to respond to
and utilize glucose
(blood sugar) was improved so much that it was the same as that of rats on a
normal (control)
diet. Cinnamon is so powerful an antioxidant that, when compared to six other
antioxidant spices
(anise, ginger, licorice, mint, nutmeg and vanilla) and the chemical food
preservatives (BHA
(butylated hydroxyanisole), BHT (butylated hydroxytoluene), and propyl
gallate), cinnamon
prevented oxidation more effectively than all the other spices (except mint)
and the chemical
antioxidants. (May 6, 2004).
[0041 ] In addition to its unique essential oils, cinnamon is an excellent
source of the trace
mineral manganese and a very good source of dietary fiber, iron and calcium.
The combination
of calcium and fiber in cinnamon is important and can be helpful for the
prevention of several
different conditions. Both calcium and fiber can bind to bile salts and help
remove them from the
body. By removing bile, fiber helps to prevent the damage that certain bile
salts can cause to
colon cells, thereby reducing the risk of colon cancer. In addition, when bile
is removed by fiber,
the body must break down cholesterol in order to make new bile. This process
can help to lower
high cholesterol levels, which can be helpful in preventing atherosclerosis
and heart disease.
[0042] Cinnamaldehyde (also called cinnamic aldehyde) has been well-researched
for its
effects on blood platelets. Platelets are constituents of blood that are meant
to clump together
under emergency circumstances (like physical injury) as a way to stop
bleeding, but under
normal circumstances, they can make blood flow inadequate if they clump
together too much.
The cinnaldehyde in cinnamon helps prevent unwanted clumping of blood
platelets. (The way it
accomplishes this health-protective act is by inhibiting the release of an
inflammatory fatty acid
called arachidonic acid from platelet membranes and reducing the formation of
an inflammatory
messaging molecule called thromboxane A2.) Cinnamon's ability to lower the
release of
arachidonic acid from cell membranes also puts it in the category of an "anti-
inflammatory" food
that can be helpful in lessening inflammation.
[0043] Cinnamon's essential oils also qualify it as an "anti-microbial" food,
and cinnamon
has been studied for its ability to help stop the growth of bacteria as well
as fungi, including the
commonly problematic yeast Candida. In laboratory tests, growth of yeasts that
were resistant to
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the commonly used anti-fungal medication fluconazole was often (though not
always) stopped by
cinnamon extracts.
[0044] Cinnamon's antimicrobial properties are so effective that recent
research
demonstrates this spice can be used as an alternative to traditional food
preservatives. In a study,
published in the August 2003 issue of the International Journal of Food
Microbiology, the
addition of just a few drops of cinnamon essential oil to 100 ml
(approximately 3 ounces) of
carrot broth, which was then refrigerated, inhibited the growth of the food
borne pathogenic
Bacillus cereus for at least 60 days. When the broth was refrigerated without
the addition of
cinnamon oil, the pathogenic B. cereus flourished despite the cold
temperature. In addition,
researchers noted that the addition of cinnamon not only acted as an effective
preservative but
improved the flavor of the broth.(October 1, 2003).
[0045] In addition to the active components in its essential oils and its
nutrient composition,
cinnamon has also been valued in energy-based medical systems, such as
Traditional Chinese
Medicine, for its warming qualities. In these traditions, cinnamon has been
used to provide relief
when faced with the onset of a cold or flu, especially when mixed in a tea
with some fresh
ginger.
[0046] In a study published in Nutrition Reviews; Mar 2006; 64, 3; Research
Library
PG. 109, Engler et al discusses the emerging role of chocolate in the
treatment of cardiovascular
health and disease. This paper reported that evidence based on epidemiological
studies suggests
that flavonoid-rich diets high in fruits and/or vegetables reduce the risk of
coronary heart
disease. Recent studies also report reduced cardiovascular risk and events
associated with the
consumption of foods rich in flavonoids.. A meta-analysis of seven prospective
cohort studies
with 105,000 individuals indicates that high dietary intake of flavonoids from
a small number of
fruits and vegetables, tea, and red wine is inversely associated with coronary
heart disease risk.
Dietary flavonoids and their potential role in the prevention of
cardiovascular disease have
gained recent scientific and medical interest due to their antioxidant
properties: their ability to
scavenge reactive oxygen species (ROS) and reactive nitrogen species.
[0047] Oxidative stress due to excess production of free radicals or ROS is
associated with a
number of cardiovascular risk factors such as hypertension, dyslipidemias,
diabetes, and
smoking. Cellular DNA, proteins, and lipids are susceptible to ROS attack,
which can result in
damage to cell membranes and organelles. Mitogeniciry and apoptosis of
vascular cells is
13
CA 02595096 2007-07-27
enhanced, and in-creased expression and activation of redox-sensitive genes
occurs. Tissue
damage and pathophysiological processes, including endothelial dysfunction and
atherosclerosis,
eventually ensue. Oxidative modification of low-density lipoproteins (LDL) due
to oxidative
stress is believed to be a major contributing factor in atherosclerosis. The
antioxidant properties
of flavonoids represent one of many diverse beneficial effects that these poly-
phenolic
compounds may exert in cardiovascular disease. The direct antioxidant-
quenching theory of fla-
vonoids is now being supplanted by other physiological theories, including
their effects on
cellular redox regulation, signal transduction, and modulation of other enzyme
and genomic
systems.
[0048] Flavonoids, a subclass of polyphenols, are ubiquitous micronutrients
derived from
plants, primarily fruits and vegetables. There are more than 5000 flavonoids
and six major
flavonoid categories: flavanols, flavanones, flavones, isoflavones, flavonols,
and anthocyanidins.
The various subclasses are listed below and include typical foods or beverages
with a substantial
content of flavonoids:
= Flavanols (catechin, epicatechin): chocolate, tea, red wine, beans, apricot,
cherry, grape,
peach, black-berry, apple;
= Flavanones (hesperetin, namgenin, eriodictyol): citrus fruits and juices;
= Flavones: (apigenin, luteolin): parsley, celery;
= Isoflavones: (daidzein, genistein): soy products;
= Flavonols: (quercetin, kaempferol, myricetin): on-ions, kale, broccoli,
tomato, blueberry,
apples, tea, red wine; and
= Anthocyanidins (cyanidin, pelargonidin, peonidin, delphinidin, malvidin):
blueberry, black
grape, cherry, blackberry, black currant, rhubarb, straw-berry, red wine,
plum, red cabbage.
[0049] The antioxidant properties of flavonoids are related to their
structure, two
aromatic rings (an A-ring and a B-ring) on the ends bound by an oxygenated
heterocycle in the
middle (C-ring), which promote free radical scavenging. Specifically, the
presence of the
catechol or dihydroxylated B-ring allows rapid donation of hydrogen (electron)
for stabilization
of radical species. This is considered the most important structural feature
defining the
"classical" antioxidant nature of flavonoids.13 Structure-activity studies
also show that
14
CA 02595096 2007-07-27
flavonoids inhibit key enzymes such as NAD(P)H-oxidase (a major source of
endogenous free
radicals), tyrosine kinase, and protein kinase based on varied
hydroxylation/methylation pat-
terns.
[0050] The number of hydroxyl groups on the B-ring and the oxo group at the 4
position of
the C-ring are also important in the suppression of cyclooxygenase-2 (COX-2),
an inducible
enzyme that is upregulated during inflammation and certain tumor formations.
Due to this
structural feature, flavanols have been found to have more suppressive
activity on COX-2 than
flavonols. It is apparent that some functions of flavonoids are dependent on
structure. While
the antioxidant properties require two hydroxyl groups on the B-ring (with no
carbonyl group at
C4 or unsaturation of the C-ring), the anti-proliferative effects of
flavonoids in many cancer
studies require the additional presence of a carbonyl group at C4 and
unsaturation of the C-ring.
Catechins and epicatechins, based on their catechol or dihydroxylated B-ring,
appear to have a
relatively restricted diversity in physiological activity. Flavonoids,
depending on their structure,
may also affect pathways in a cell- or tissue-specific manner depending on
their structure.
[0051] Recent reviews also suggest that flavonoids exert non-antioxidant
mechanisms that
may confer protection such as binding to receptors, modulation of cellular
signaling (i.e., protein
and lipid kinase pathways), and gene expression. For example, flavonoids of
the catechin family,
major constituents of red wine, have been found to mediate the inhibitory
effects of red wine on
(3-platelet-derived growth factor (PDGF) receptor signaling, PDGF-dependent
proliferation,
and migration of vascular smooth muscle cells. PDGF is a potent mitogenic and
chemotacric
factor and one of many inflammatory components that contribute to
atherogenesis.
Interestingly, the findings of this study are believed to provide a molecular
explanation for the
"French paradox" in that the French have a high consumption of red wine and
one of the lowest
incidences of coronary heart disease despite a diet with a high fat content.
[0052] Cocoa and chocolate contain both a high quantity and quality of
antioxidant
flavonoids, even exceeding black and green tea and red wine. Cocoa and
chocolate,
especially dark chocolate, have only recently been identified as rich sources
of flavonoids due
to advances in technology and analytical methods used in the detection of
complex
flavonoids. The high antioxidant capacity of cocoa and chocolate are
attributed to their
significant amount of procyanidins, the oligomeric form of the flavanol
monomeric units, (-)-
epicatechin and (+)-catechin. These monomers, mainly (-)-epicatechin, provide
most of the
CA 02595096 2007-07-27
total procyanidin content in chocolate; however, dimers (two monomer units)
and up to 10
monomer units are also present. The amount of flavonoids in chocolate is not
only dependent
on the cacao bean, but also on the processing steps involved in chocolate's
manufacture. For
example, excess heat and alkalization ("Dutch" processing) can significantly
reduce the
amount of flavonoids. Typically, dark chocolate contains two to three times as
many cocoa
flavonoids as milk chocolate.
[0053] The antioxidant capacities of foods and beverages measured by current
methodology,
i.e., oxygen radical absorbance capacity (OR.AC-) assay with fluorescein,
Trolox equivalent
antioxidant capacity (TEAC), total radical-trapping antioxidant parameter
(TRAP), ferric-
reducing ability of plasma (FRAP), may not reflect in vivo antioxidant
effects. The measurement
of antioxidant capacity, which reflects the concentrated polyphenolic content
of the food or
beverage, is also not comparable among the different methods. Measurement of
both the
lipophilic and hydrophilic fractions in a given sample are needed to obtain an
accurate total
ORACFL (total antioxidant capacity) value.
[0054] Other factors such as processing, plant genetics, season, and growing
conditions may
also alter the phenolic content and, thus, the antioxidant capacity of foods.
Therefore, the content
of flavonoids in various foods and beverages and their respective antioxidant
properties may be
dependent on a number of factors. Careful evaluation of these factors and the
methodology used
for measurements are important. With these considerations, flavonoids,
specifically, the
flavanols catechin and epicatechin, may be beneficial in cardiovascular health
and disease
based on their antioxidant properties, anti-proliferative effects, and other
emerging physiolog-
ically relevant mechanisms.
10055] Engler reported that the decreased susceptibility of LDL oxidation has
recently been
ascribed to the cocoa flavonoids and discusses the literature references.
[0056] Endothelial dysfunction is recognized as an early event in the
development of
atherosclerosis, and is associated with decreased bioavailability of the
vasodilator nitric
oxide. Current evidence suggests that the consumption of cocoa and chocolate,
rich in
flavonoids, may provide protective vascular effects. In isolated rabbit aortic
rings, cocoa
extracts were shown to induce endothelium-dependent relaxation and to activate
endothelial
nitric oxide synthase. Oligomeric forms of the monomeric units (-)-epicatechin
and (+)-
catechin, such as tetramers and higher, were associated with these effects.
Additionally, a
16
CA 02595096 2007-07-27
favorable balance in eicosanoid synthesis has been reported in cultured human
aortic
endothelial cells exposed to cocoa flavanols and in human plasma samples from
subjects 2
hours following the consumption of high-flavanol chocolate (37 g). A decrease
in the plasma
leukotriene-prostacyclin ratio was also found, which would result in more
vasodilation, less
platelet aggregation, and an anti-inflammatory profile. A significant rise in
plasma
epicatechin was also noted at the 2-hour time point following chocolate
consumption.
[0057] Studies have shown in healthy subjects following 4 days to 2 weeks of
daily
consumption of a cocoa beverage or flavonoid-rich dark chocolate bar,
increased vasodilation or
improvement in endothelial function.
[0058] The cardioprotective mechanisms may be related to increases in plasma
epicatechin
or catechin concentrations that signal release of vasoactive substances from
the endothelium,
including nitric oxide and prostacyclin.
[0059] Studies also provide evidence for increased nitric oxide synthesis and
beneficial
changes in the eicosanoid ratio. Epicatechin in particular has been recently
found to protect the
integrity of endothelial cells by scavenging free radicals and by maintaining
endothelial nitric
oxide synthase. Moreover, several of the studies measured endothelium-
dependent, flow-
mediated dilation, which reflects an increase in flow and shear stress after
reactive hyperemia,
and is mediated by endothelium-derived nitric oxide and possibly prostanoids
derived from the
endothelium. When considered together with the increased expression and/or
activity of
endothelial nitric oxide synthase seen with long-term exposure to epicatechin
and related
polyphenols, this research provides a molecular basis for the cardioprotective
effects of high
epicatechin/catechin-containing foods and drinks.
[0060] In healthy subjects, the effects of cocoa and chocolate on blood
pressure have been
negative, with the exception of two recent studies. Two randomized, crossover
trials in
untreated hypertensives have also shown a blood pressure lowering effect
following 14 to 15
days of consumption of 100 g of dark chocolate. A recent report suggests that
cocoa flavanols
may lower blood pressure by acting as an angiotensin I converting enzyme
inhibitor, which also
has antioxidant properties and can modulate nitric oxide production.
[0061] A suppressive effect on platelet reactivity and platelet-related
primary hemostasis has
been demonstrated in many studies even after a single chocolate dose. The anti-
platelet effects
of cocoa and chocolate may be due to increased production of nitric oxide,
which not only causes
17
CA 02595096 2007-07-27
vasodilation, as previously discussed, but also inhibits platelet aggregation.
Increased plasma
epicatechin concentrations were reported in the studies by Pearson et al. and
Murphy et al., and
may signal increased nitric oxide synthesis in both the endothelial cells and
platelets. Increased
production of prostacyclin, an inhibitor of platelet aggregation, has also
been proposed as a
possible mechanism.These platelet inhibitory effects by cocoa and chocolate
may be beneficial
due to the pathophysiological role of platelets in artherosclerosis and
thrombotic events.
[0062] It is now widely accepted that atherosclerosis is a chronic
inflammatory disease.
Inflammation and in-creased oxidative stress promote endothelial dysfunction
and
atherogenesis. Nitric oxide normally inhibits nu-clear transcription factor
(NFKB), which
binds to the promoter regions of genes coding for pro-inflammatory proteins
such as
cytokines and adhesion molecules. In endothelial dysfunction, which is
manifested by de-
creased bioavailabilty of nitric oxide, this inhibition is loss. Excess
intracellular ROS in
oxidative stress also activates NFKB Cocoa flavonoids may prevent activation
of NFKB and
subsequent cytokine transcription by diminishing intracellular ROS.
[0063] In experimental studies, the expression of the pro-inflammatory
cytokines
interleukin(3(IL-1(3) and interleukin-2 (IL-2) is modulated by cocoa
flavonoids. Specifically, IL-
expression in phytohemagglutininstimulated peripheral blood mononuclear cells
is reduced
by purified monomer to tetramer cocoa flavonoids and IL-2 mRNA expression of
and secretion
by T-cells have also been shown to be inhibited with cocoa treatment. Cocoa
flavonoids
(epicatechin, catechin, dimeric procyanidins) are also incorporated into
Jurkat T-cells with
pretreatment, which inhibits phorbol miristate acetate (PMA)-induced NFKB
activation. This
finding suggests that the immune response can be regulated by cocoa
flavonoids, in part by
modulating the oxidant-responsive transcription factor NFKB.
[0064] Cocoa-derived dimers have recently been found to protect Jurkat T-cells
from
oxidation and to increase plasma membrane fluidity. They also maintain the
membrane integrity
by preventing leakage of small molecules from vesicles. The increase in
membrane fluidity may
be linked with functional changes in membrane-associated receptors and enzymes
as well as ion
transport. Mathur et al.recently reported that cocoa products have no effect
on markers of
inflammation (whole-blood cytokines, IL-10, IL -6, TNF-a, high-sensitivity C-
reactive
proteins, and P-selectin). The healthy subjects in this study consumed the
cocoa and chocolate
supplementation (651 mg of cocoa flavonoids) for 6 weeks. Epicatechin was not
detected in
18
CA 02595096 2007-07-27
the subjects' plasma, and the lack of effect on inflammatory markers was
attributed to the short
half-life of cocoa flavonoids. It is known that epicatechin As in the plasma
at 2 hours after
cocoa or chocolate consumption and is cleared approximately 8 hours later.
[0065] The present inventors have shown that the new therapeutic formulation
comprising
cinnamon and chocolate demonstrates synergist activity and inter alia:
(a) healthy glucose level for people with type 2 diabetes;
(b) optimum level of cholesterol and triglycertides for people of all ages and
thus
reduces the risk of cardiovascular disease.
[0066] The new therapeutic formulation has also been proven as a powerful
antioxidant and
effective in helping to prevent cancer, heart disease, and stroke.
[0067] Another major benefit of the new therapeutic formulation is that it can
prevent insulin
resistance, a major and common complication that develops in people with type
II diabetes in
later years.
[0068] The two main ingredients of the new therapeutic formulation come from
cinnamon
and chocolate. Both the ingredients have been successfully used as effective
remedies for many
medical conditions in Indian, Chinese and South American Traditional Medicine.
[0069] Chocolate has been observed in clinical trials to improve
cardiovascular health by
improving endothelial cell functions.
[0070] The chocolate used is dark chocolate and must be rich in flavonoids. It
is thought that
the chocolate contains procyanidins flavanol, (-)-epicatechin and (+)-
catechin. The anti-
inflammatory action is thought to have been caused by the prevention of the
activation of NF kB
and subsequent cytokine transcription by diminishing intracellular free
radicals. In experimental
studies, the express of the pro-inflammatory cytokines interleukin-b (IL-lb)
and interleukin-2
(IL-2) is modulated by cocoa flavonoids. It is also thought that the flavanol
modulate NO status,
potentially increasing NOS or inhibiting the NO conversion to peroxynitrite.
It is thought that
this is done by the B (NF-k regulation of nuclear transcription factor-kB)
which controlsl the
expression of many enzymes including inducible nitric oxide synthase (iNOS)
and
cyclooxygenase-2 (COX-2). INOS induces NO in response to pro-inflammation
agents. COX-2
is also induced by pro-inflammatory agents. Thus it is thought that the anti-
inflammatory action
is caused by the inhibition of the enzyme xanthine oxidase which is part of
the pathway when the
19
CA 02595096 2007-07-27
body creates uric acid. The body's respone to a buildup of uric acid is
similar to that of
inflammation.
[0071] With respect to the reduction of blood sugar, insulin sensitivity is
partly dependent on
insulin-mediated NO release. Thus, the antioxidants may decrease insulin
resistance by
ameliorating NO bioavailability.
[0072] Chocolate contains linoleic and oleic acid which are two fatty acids
that are known to
modulate cholesterol metabolism. Although it has been demonstrated in clinical
trials, the
mechanism of action is not understood as yet. The cardiovascular health is
improved by
improving flow-mediated dilation which improves endothelial functions. The
endothelial cells
are involved in many aspects of vascular biology including the control of
blood pressure, blood
clotting, atherosclerosis, the formation of new blood vessels, inflammation
and swelling and
controlling the passage of materials and the transit of white blood cells.
[0073] The chocolate may be sourced from any well known product such as
chocolate itself,
chocolate milk, chocolate pudding or chocolate yogurt.
[0074] In this regard, a product formulation has been invented which
incorporates the novel
herbal product into a vehicle comprised substantially of chocolate. Although
the product may be
incorporated into any suitable chocolate vehicle, a particularly useful
process and product is
hereinafter described.
[0075] It has been found that certain chocolate form better vehicles than
others. In
particular, it is desired to use a sugar free chocolate formulation to avoid
additional sugar in the
final product.
[0076] The inventors have found the following four particularly useful
formulations for the
chocolate vehicle. Each of the following formulations do not contain any added
sugar and are
commercially available.
[0077] The first formulation is a dark chocolate which comprises forty-three
percent (43%)
maltitol, cocoa butter and cocoa powder processed with an alkali. A chocolate
liquor and cocoa
powder along with milk fat and soya lecithin which is used as the emulsifier,
and natural
flavours.
[0078] A second formulation relates to a milk chocolate which contains
maltitol in the
amount of fifty-five percent (55%), cocoa butter and a chocolate liquor.
Calcium carbonate and
CA 02595096 2007-07-27
milk fat are added as well as calcium caseinate and soya lecithin as the
emulsifier with vanilla
extract for taste.
[0079] A third useful formulation is a high protein sucrose free milk
chocolate which
includes maltitol, fractionated modified palm kernel oil, milk protein
concentrate and cocoa
powder. Calcium caseinate, soya lecithin as the emulsifier and vanilla extract
are used.
[0080] The fourth formulation is a dark sugar free coating which is comprised
of a chocolate
liquor processed with an alkali, maltitol, cocoa butter, butter oil, soya
lecithin as the emulsifier
and vanilla extract.
[0081] The inventors have found the following process to be particularly
useful.
[0082] The chocolate is first melted to a minimum temperature of ninety-five
degrees
Fahrenheit (95 F) to a maximum of one hundred and twenty degrees Fahrenheit
(120 F).
Preferably, the chocolate is placed within a water jacketed kettle which has
an agitator. After
melting of the chocolate, the jacket is cooled to a temperature of sixty
degrees Fahrenheit (60 F)
to a maximum of ninety degrees Fahrenheit (90 F). The chocolate is allowed to
cool to a
minimum of sixty-eight degrees Fahrenheit (68 F) to a maximum of eight-nine
degrees
Fahrenheit (89 F) with the agitator running. The agitator continues to run
until the chocolate
starts to thicken.
[0083] After the chocolate has thickened, the jacket is gradually warmed to a
temperature of
a minimum of eighty degrees Fahrenheit (80 F) with the agitator running. The
chocolate is
warmed to a temperature between eight-five degrees Fahrenheit (85 F) to ninety-
five degrees
Fahrenheit (95 F) with the agitator running and the cinnamon is then added to
this warmed
chocolate in slow measures with the agitator running. The product is
thoroughly mixed and
when the mixing is completed, the jacket temperature is reduced. The chocolate
is then poured
into molds and cooled in a cooling tunnel.
[0084] It is preferred that the molds in which the chocolate is poured are
kept at a
temperature between seventy-eight degrees Fahrenheit (78 F) and eighty-two
degrees Fahrenheit
(82 F). The cooling tunnel subjects the chocolate in the mold to an initial
cooling at a
temperature between sixty-five degrees Fahrenheit (65 F) and seventy degrees
Fahrenheit (70 F),
to a main cooling stage between forty-five degrees Fahrenheit (45 F) to fifty
degrees Fahrenheit
(50 F) and to a final cooling stage of between sixty-five degrees Fahrenheit
(65 F) to seventy
degrees Fahrenheit (70 F).
21
CA 02595096 2007-07-27
[0085] It is preferred that for every forty (40) grams of chocolate, the
product will contain
between one hundred and fifty (150) milligrams to a maximum of one thousand
(1000)
milligrams of the cinnamon.
[0086] This produces an excellent product which finds wide acceptance with the
consumer in
view of the chocolate extract.
[0087] It has been found that the efficacy of the cinnamon is enhanced when
about 3000
milligrams to about 6000 milligrams of cinnamon powder is ingested per day.
Cinnamon extract
is extracted from cinnamon powder in a ratio of about 1:10 so that either 3000
to 6000
milligrams of cinnamon powder or 300 to 600 milligrams of cinnamon extract
will achieve the
same result.
[0088] A standard conventional chocolate bar contains 43 grams of chocolate.
In the
preferred embodiment, the chocolate incorporates 500 milligrams of cinnamon
extract (which is
equivalent to 5000 milligrams of cinnamon powder) in a 43 gram chocolate bar.
The synergistic
results are achieved by ingesting one chocolate bar per day which will deliver
an optimum
amount of cinnamon powder per day to the individual.
[0089] Although the disclosure describes a preferred embodiment, the invention
is not so
limited. For a definition of the invention, reference is made to the claims.
22
