Nutrition Specialist Exam
Section C – Supplement Topic
David Story
Cortislim
I
am writing about the supplement Cortislim. I picked this supplement for my
topic partially because I felt Cortislim made some inflated claims. Midway through researching this paper it came
to my attention that a lawsuit was brought up against the makers of
Cortislim. I do not know anything at all
about the lawsuit. I decided against
learning more until I completed the assignment.
However, I did notice that the Cortislim website changed over the period
that I wrote the paper.
The
most notable change on the website is the strong emphasis on the “Cortislim
Lifestyle”. The “Cortislim Lifestyle”
stresses exercise, proper diet, and stress management combined with
supplementation (using their product).
While these were on the website prior to the change, they were not
featured as prominently on the home page as they are now. Coinciding with this is a noticeable absence
of the word cortisol on the home page, which was strongly implicated as a major
barrier to weight loss.
Introduction:
The
product Cortislim is billed primarily as a fat loss supplement, purportedly by
controlling cortisol levels. According
to the Cortislim website, the hormone cortisol signals two actions in the body:
increase of appetite and storage of fat.
While this is true, there is more to the story.
Cortisol
levels increase in response to stress (it is often referred to as “the stress
hormone”).
Among other things, increased cortisol levels signal a breakdown of
muscle tissue into amino acids to be converted into glucose by the liver
(gluconeogenesis). This allows the brain
to have an uninterrupted supply of glucose under stressful conditions (1).
Cortisol performs several other jobs, like helping to maintain blood pressure and cardiovascular
function, reducing the immune system’s inflammatory response, balancing the
effects of insulin in breaking down sugar for energy, and regulating the
metabolism of proteins, carbohydrates, and fats.
Normally,
the production and release of cortisol is tightly controlled by the brain and
pituitary & adrenal glands. The
hypothalamus sends corticotropin-releasing
hormone (CRH)
to the pituitary gland causing the release of adrenocorticotrophin
(ACTH). ACTH is then released into the bloodstream,
acting on the adrenal glands to release cortisol. (2)
There is a condition, Cushing’s
syndrome, in which body tissues are exposed to cortisol for prolonged
periods. It develops due to abnormal
overproduction of cortisol by the adrenal glands or due to prolonged exposure
of the body’s tissues to cortisol (from ingestion of corticosteroids or from
tumors affecting the pituitary or adrenal glands). Symptoms of Cushing’s syndrome include
hypertension, diabetes, abdominal stretch marks, and accentuated fatty tissue
on face and upper back (1). The
Cortislim website does not mention Cushing’s syndrome.
Theory
behind cortislim:
Excess
cortisol has been associated with an
increase in appetite. In addition, there is a pattern of fat distribution
associated with excess cortisol: fat tends to be stored in the abdominal area
as opposed to the hips (1).
Viewing
the Cortislim website prior to its recent changes, it appeared Cortislim is
formulated to counteract these two effects of cortisol, as well as several
other mechanisms for weight loss. These
include “help balance blood sugars”, “help optimize overall metabolic rate” and
“burn fat”. Other benefits of taking
Cortislim are “less stress”, “more energy”, and “better mental focus”.
Cortislim
is composed of a number of ingredients including Calcium, Vitamin C, Chromium,
and three proprietary herbal blends. The
blends are described below, followed by an explanation of their purported
effect. These explanations no longer
appear on the website.
“Cortiplex” = Magnolia Bark Extract (1.5% honokiol) +
Beta-Sitosterol + Suntheanine (100% L-Theanine)
Controls
cortisol levels (to reduce fat storage and promote fat mobilization)
“Leptiplex” = Green Tea Extract (50% EGCG) + Bitter Orange
Peel Extract (5% Synephrine)
Helps
to naturally control appetite, increase energy levels and stimulate metabolism
“Insutrol” = Banaba Leaf extract (1% corosolic acid) + 5%
Vanadyl Sulfate (5 mcg vanadium)
Helps
to maintain healthy glucose levels. Also
helps to reduce cravings.
The
remaining ingredients are gelatin, microcrystalline cellulose, water, silicon
dioxide, and magnesium stearate.
Research Summary:
Excess
Cortisol and body fat:
The
link between excess cortisol and body fat is frequently written about in
fitness and weight loss articles.
Cortisol is mentioned in the same breath as sleep deprivation,
over-training, job stress or another stressor.
Readers are then admonished that the stressor (associated with the
elevated cortisol) could be sabotaging their weight loss efforts, or worse,
making them fat.
The
evidence supporting these ideas has been building for years. A study in the Annals
of the New York Academy of Sciences (December 1995) showed that high cortisol
levels associated with chronic stress might exert a fat storing effect on the
body, particularly with regards to intra-abdominal fat (3).
Psychosomatic
Medicine (the journal of the American Psychosomatic Society) published a study
in February 2000 in which fifty-nine healthy pre-menopausal women were
enrolled. The women were grouped
according to low (n=29) or high (n=30) WHR (Waist Hip Ratio). A low WHR corresponded to low abdominal fat
storage. The authors concluded that cortisol secretion might contribute to
central fat in otherwise lean women (4).
They suggested however, that excess cortisol might not be as strongly related
to abdominal fat in women who are overweight.
Also, the findings cannot necessarily be applied to men, since only
women were enrolled in the study.
Researchers at
Lowering
excess cortisol:
Depending on the cause, there are a number of options for
lowering excess cortisol without the use of supplements, drugs or other
substances. The choice may depend on the
reason for the cortisol elevation. More
sleep, relaxation or stress management techniques, reduced intake of
cortisol-elevating substances (such as caffeine), removal of a stressor and
proper fitness training are all methods commonly recommended for lowering
elevated cortisol levels (1).
Lowering
cortisol in Cushing’s patients:
According to the National Institute of Diabetes and Digestive
Kidney Diseases (NIDDK), there are a variety of approaches to treating
Cushing’s patients. If a tumor is the
cause of the increased cortisol production, methods such as surgery, radiation,
or chemotherapy are used. If the cause is long-term use of
glucocorticoid hormones to treat another disorder, a gradual dosage reduction
to the lowest dose adequate for control of that disorder may be attempted. Cortisol-inhibiting drugs are sometimes an
option also (10). Notably, it does not look as if any of the
“Cortiplex” ingredients (magnolia bark, beta-sitosterol, or theanine) make up
any of these cortisol-inhibiting drugs.
I could not find any studies or research demonstrating the
cortisol lowering effects of Cortislim
(my opinion on this fact follows in the “Opinion” section). Therefore I will discuss research on the
three ingredients in “Cortiplex”, the proprietary herbal blend in Cortislim
stated to be responsible for lowering cortisol.
Again “Cortiplex” is made up of Magnolia Bark, Beta Sitosterol and Theanine.
Magnolia Bark
Magnolia bark is a
traditional Chinese medicine used for treating "stagnation of qi"
(low energy) as well as digestive disturbances caused by emotional distress and
emotional turmoil. It is rich in
magnolol and honokiol, with both compounds said to contribute to Magnolia Bark’s
anti-stress and cortisol-lowering effects (6). Animal studies have shown honokiol acts as a
non-sedating, anti-anxiety and anti-stress agent at lower doses. I was not able to find research suggesting
that either honokiol or magnolol has a direct effect on cortisol or on the
adrenal glands (where cortisol is produced).
It looks as though
the purpose of including Magnolia bark in Cortislim is to keep stress levels at
bay, which would presumably influence cortisol production. The SupplementWatch
website says newer claims are emerging to link magnolia bark’s anti-stress
benefits with control of cortisol. There
is no evidence in the form of human studies however.
Beta-Sitosterol is a phytosterol, which is a plant compound
that has a chemical structure similar to cholesterol (7). It
is sometimes used to treat prostate problems, urinary difficulties and high
cholesterol. The May 1999 International
Journal of Sports Medicine published a pilot study in which nine marathoners
received a supplement capsule containing Beta-Sitosterol, and eight other
marathoners received a placebo. It was
determined that the Beta-Sitosterol significantly decreased the ratio of
cortisol to DHEA (8).
With other effects, this was interpreted to mean Beta-Sitosterol could
help lower immunosuppression responses related to exercise stress.
Theanine
is an amino acid found in green tea leaves.
It is thought to act as a non-sedating relaxant that
helps increase the brain's production of alpha waves (brain waves associated
with "relaxed alertness"). By doing so, theanine is thought to
control anxiety, increase mental focus, and improve concentration (6). In its description of L-theanine, the
pdrhealth website cites a trial that involved a small
group of 18-22 year old women. The trial
showed a dose-dependent increased production of alpha waves in those who
consumed 200 mg of L-Theanine compared to those who consumed water. It was suggested that more rigorous follow-up
is required (9).
Controlling
appetite:
Cortislim’s
proprietary herbal blend “Leptiplex” is composed of green leaf tea extract (with EGCG) and Bitter Orange Peel Extract (with
Synephrine). Leptiplex is supposed to
naturally control appetite, increase energy levels and stimulate metabolism.
The
list of benefits attributed to green tea consumption, such as boosting the
immune system and arthritis prevention, has been growing in recent years. EGCG is one of four major catechins
(polyphenols), the active components of green tea. Antioxidant benefits ascribed to green leaf
tea extract include cancer prevention, lowering of cholesterol, and reduction
of blood pressure (9). It is usually the EGCG component of green tea
that is credited with contributing to appetite suppression and enhanced
metabolism.
In
2000, researchers at the
The website for “Science a GoGo”
describes a study in which ten young obese males consumed green tea extract
(with caffeine), caffeine alone, or placebo
with a prepared meal.
Green tea consumption led to a 4% increase in thermogenesis and a 4.5%
increase in overall energy expenditure. (12). The subjects that had caffeine only showed no change in
metabolic rate. The website made no
reference to the study appearing in any medical or science journals.
A
study at
A compound called octopamine, found in bitter orange peel
extract, is reported to be potentially involved in appetite control. According to chasefreedom.com, a website
aimed to provide diet reviews and information, this assertion stems from a
study showing that octopamine stopped bugs from eating citrus fruit (14). However, I was unable to find evidence this
study, or of any evidence of an appetite suppression effect from octopamine.
Synephrine is chemically similar to ephedrine, a stimulant
that has gotten press for having been pulled off the market for its health
risks. Touted as a mild stimulant,
synephrine is alleged to cause an elevation in metabolic rate (caloric
expenditure), without the same negative cardiovascular side effects as
ephedrine
(6). Synephrine
is said to target some body tissues more selectively (fat cells more, heart
cells less) than epinephrine. I was unable to find research
showing that synephrine is proven safe or that synephrine has an appetite
suppressing effect.
Maintain
healthy glucose levels:
“Insutrol” is composed of banaba leaf extract and vanadyl
sulfate. These are each reported to help
lower blood glucose levels.
Banaba
leaf extract is used in the
Vanadyl sulfate is the most common supplemental form of a
mineral called vanadium. Vanadium is
thought to imitate the effects of insulin, thus maintain blood glucose levels (6). One
study showed large doses of vanadyl sulfate lowered blood sugar levels in
people with Type II diabetes, but not dramatically, according to the Nutrition
Action Letter (17). Human research on the effect of vanadium as
it relates to blood glucose is scant.
Chromium,
calcium, and Vitamin C are in Cortislim as well. There is evidence that these may have the
effects that are credited to the herbal ingredients described above. These
three essential nutrients are each widely consumed in supplement form.
According to the UC Berkeley wellness
letter, chromium is an essential mineral, but deficiency is rare in the
In
another study, mice were fed a calorie-restricted diet and consumed calcium in
one of three ways: a calcium supplement, a medium amount of low fat milk, or a
high amount of low fat milk. The percent
fat loss for each group was 42%, 60% and 69% respectively, compared to an 8%
fat loss for a group that had no calcium supplementation (20).
A
Vitamin C study demonstrated a stress reducing effect in people who were put
into a stress-inducing situation. Sixty
of 120 subjects were given 1,000 mg of Vitamin C, and sixty were given placebo. Blood pressure, cortisol, and subjective
responses to a stress test were all lower in the Vitamin C group (21).
A
1999 rat study showed large Vitamin C doses lowered blood cortisol levels. The doses were the equivalent of several
thousand milligrams in humans. In addition, other markers of emotional and
physical stress, such as body weight and
enlarged adrenal glands, were positively affected
(22).
References:
1.About.com
2.Medicinenet.com/stress
3.PUBMED -- >Peeke
PM, Chrousos GP. (1995). Hypercortisolism and obesity. Annals of the
New York Academy of Sciences, 771, 665-676
4.Psychosomatic
Medicine (the journal of the American Psychosomatic Society) Epel, E.S.,
McEwen, B., Seeman, T., Matthews, K., Castellazzo, G., Brownell, K.D.,
http://www.psychosomaticmedicine.org/cgi/content/full/62/5/623
5.http://home.caregroup.org/newsnow/pr_out.asp?pr_id=253
6.http://www.supplementwatch.com/
7.http://www.wholehealthmd.com/refshelf/substances_view/1,1525,972,00.html
8.PubMed -àInt J Sports Med. 1999 May;20(4):258-62.
9.http://www.pdrhealth.com/drug_info/nmdrugprofiles/nutsupdrugs/lth_0296.shtml
10. http://www.niddk.nih.gov/health/endo/pubs/cushings/cushings.htm
11. Endocrinology Vol. 141, No. 3 900-987.
http://endo.endojournals.org/cgi/content/full/141/3/980
12. http://scienceagogo.com/news/19991029004721data_trunc_sys.shtml
13. PubMed -à In Vivo. 2000 Jul-Aug;14(4):481-4
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10945161&dopt=Abstract
14. chasefreedom.com
16. http://www.pdrhealth.com/drug_info/nmdrugprofiles/nutsupdrugs/col_0081.shtml
17. http://www.cspinet.org/nah/05_01/
18. http://www.berkeleywellness.com/html/ds/dsChromium.php
19. http://content.health.msn.com/content/article/63/72079.htm
20. http://my.webmd.com/content/article/23/1728_56703
21. Psychopharmacology (Berl). 2002 Jan;159(3):319-24. Epub 2001
Nov 20. (PubMed)
22. http://www.anomalous-images.com/news/news499.html
Opinion:
Basis
for product need
Based
on the product name, as well as statements on their radio advertisements and
website, the manufacturers of Cortislim primary aim is to implicate the hormone
cortisol in people’s failure to lose weight.
While research indicates a connection between abdominal body fat and
cortisol, it does not look to be a direct cause and effect scenario. Many of the studies are on animals.
The
study I referred to (from Psychosomatic Medicine) was a small, case control study.
The authors suggested that cortisol might not be as much of a factor for
abdominal fat storage in overweight women as in lean women. This suggests elevated cortisol can affect
people differently, causing only some to store fat (the research saying
cortisol has direct effect on fat deposition is inconsistent). Also, people with high stress do not
necessarily have high cortisol levels.
As
I write in the section on Cortislim’s marketing (below), no one would conclude
such distinctions exist when looking at Cortislim’s website. Instead there were blanket insinuations that
stress leads to elevated cortisol levels which leads to weight gain and/or
failure to lose weight.
If a client
truly had elevated cortisol levels (known by getting an adrenal stress test),
I’d suggest to that individual possibly more testing and definitely talking to
a doctor. In the interim, I’d recommend
behavioral changes to lower cortisol levels.
More importantly, in my role as a personal trainer, I would focus on
exercise as a means for combating stress and losing weight.
No
Clinical Trial
Ideally, a double blind, placebo
controlled trial would be conducted to determine the safety and efficacy of
Cortislim. A significant
number of overweight subjects with high cortisol levels would need to be
recruited. Baseline cortisol and body
fat percentages would need to be established for each subject. Subjects would take Cortislim or placebo for
a period, and then cortisol levels and body fat percentage would need to be
measured for a second time.
The
study would need to determine whether those who take Cortislim have lower
cortisol levels and lower levels of body fat at the end of the study. Those who took placebo would act as control
group, with variables like activity levels, food intake, sleep and stress
levels being controlled for also. In
addition, safety would have to be monitored. The fact that there is no such
research on the safety or effectiveness of this product is the most critical
reason why I am against it. Simply put,
its effects are unknown.
The
website actually promotes undertaking lifestyle changes, like exercise, proper
nutrition, and stress management, to go along with supplementation, as “a vital
link to better managing your everyday stress”.
The
suggested eating habits (in the website’s “User Guide”) include:
-
Eat fresh and natural
whole foods. Avoid processed, artificial foods.
-
Avoid caffeine and
sugar.
-
Stop eating past 7pm,
or three hours before bedtime. Instead of having one large meal, break up your
meals into smaller portions spread throughout the day.
-
Drink plenty of water
and replace soda with water. Water suppresses appetite and helps metabolize
fat. On average, a person should drink at least 8 glasses of water a day.
Suggested
changes for managing stress include:
-
Take 30 minute breaks to relax
-
Get eight hours of sleep
-
Avoid stimulants like caffeine
-
Do low impact exercise
While these recommendations are positive, they make it
impossible to know the effect of Cortislim on stress and weight
management. If the user loses weight, it
may be a direct result of the lifestyle changes. Instead of striving to isolate the effects of
their product, the makers muddle the picture by encouraging consumers to use
Cortislim in combination with demonstrated weight loss and stress management
solutions.
Ingredients
Beyond
the fact that there is no published research on Cortislim’s product, there does
not seem to be sufficient research to support the claims for the proprietary
ingredients. Given the number of
ingredients in these herbal blends (seven total), one would hope for more
quality human trials to refer to.
The
FDA monitors drug studies to ensure that they are conducted properly. We do not have that assurance (or the
assurance that there was human testing done at all) when it comes to the herbal
ingredients. Thus the safety of
Cortislim is unknown.
In
terms of efficacy, there is nothing that convinced me that Cortislim’s
proprietary herbal blends has a direct effect on cortisol or on the adrenal
glands’ production of cortisol.
“Cortiplex”, the blend of three herbs purportedly responsible for such
an effect, at best has a calming effect that may influence anxiety levels.
The
most promising herbal ingredient in Cortislim is green tea extract (part of
“Leptiplex”. The evidence to support the
claims of appetite suppression and increased metabolism is not overly
compelling, but it better than for any of other the herbal ingredient
claims. Evidence that bitter orange
(with synephrine) has an appetite-suppressing effect could not be found. While synephrine may have metabolism
increasing effects, it is not clear that synephrine is necessarily safe.
In
my opinion, the most compelling support for Cortislim’s efficacy claims can be
credited to calcium and Vitamin C. The
research behind calcium’s fat loss effects and behind Vitamin C’s cortisol
controlling effects is more persuasive than that of “Cortiplex” or “Leptiplex”
As
I said at beginning of the paper, the Cortislim website has recently
changed. The following statements were
copied from the website prior to the changes:
·
“Anybody who leads a
stressful lifestyle and wants to lose weight can benefit from CortiSlim™. CortiSlim™ is formulated to promote
weight loss, increase energy levels, and control appetite in the millions of
Americans who experience stress on a daily basis. This makes CortiSlim™
the perfect product for everyone from athletes, to executives, to soccer moms,
and everyone in between.”
·
CortiSlim™ should be taken as long as you have
everyday stress in your life, and as long as you want to manage your
weight. If you stop taking CortiSlim™,
but still have stress in your life, your cortisol levels will shoot back up,
and the whole fat-making process will start again. Even after you reach your
weight loss goals, you will still want to take CortiSlim™ everyday
simply because of how healthy it makes you feel!
·
“Suddenly, you'll
realize that your clothes are fitting more loosely, even before you've lost a
single pound!”
·
CortiSlim™ will send you strong signals to avoid
reaching for snacks or overeating, but it's up to you to listen. With CortiSlim™,
it's easier to resist jelly donuts in the morning and a bag of chips in the
afternoon. You'll realize that you will eat until you're full, instead of
finishing everything on your plate. Instead of craving junk food, you'll start
craving healthy foods. When stress and cortisol are no longer a controlling part
of your life, you'll find freedom from food, so you'll be free to live your
life!”
Before
the changes, the website contained many misleading statements implying that
virtually everyone living in our society is exposed to stress levels that will
lead to increased cortisol levels. Also,
cortisol was said to be “one of the primary physiological signals for weight
gain”. Noticeably absent from the
website is mention of side effects.
There is only a statement that “there will be a range of effects
experienced by users”.
The
overall content of the website solidifies my belief that Cortislim’s claims
cannot be believed. I would not
recommend use of Cortislim because I doubt it’s effectiveness, and I would urge
anyone who was using it to stop doing so based on the fact that its safety is
unproven.