The Effect of A Novel Food Supplement Containing a Mixture of Water Extracted Herbs and 1.3-1.6-Beta-Glucan on Body Composition and Weight in Females

Draft II Publication
The effect of a novel food supplement
containing a mixture of water extracted
herbs and 1.3-1.6-beta-glucan on body
composition and weight in females. The
results from a blinded placebo-
controlled pilot study.
Erling Thom; Ph.D.; ETC Research and
Development AS, Oslo, Norway

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The effect of a novel food supplement containing a mixture of water extracted
herbs and 1.3-1.6-beta-glucan on body composition and weight in females.

The results from a blinded placebo-controlled pilot study.

Erling Thom; Ph.D.; ETC Research and Development AS, Oslo, Norway
Summary
The results from this placebo controlled clinical study in 28 middle age females with mild to moderate
overweight (BMI ? 27.5 kg/m2) and with a waist circumference (WC? 90 cm) show during a treatment
period of 30 days significant reductions in body weight, BMI, BF% as well as significant reductions of
waist, abdominal and hip circumferences. With respect to the mechanism of action of the treatment it
might be that the combination of the herb mixture and the 1.3-1.6-?-glucan has a favorable effect on
the gastrointestinal system digestively as well immunologically.
Key Words: Herbs, glucan, overweight, fat reduction.
Introduction
balance. Although no one disputes the laws of
thermodynamics, some alternative suggestion
The metabolic syndrome, operationally defined
for the etiology of obesity have been
as presence of any three of the following
discussed. The expression “infectobesity”
factors: Central obesity(high waist
describes the possibility that obesity may be
circumference), hyperglycemia, high blood
associated with viral infections or a particular
pressure , low high-density lipoprotein
behavior of the intestinal bacterial mass.
cholesterol (HDL- C) or high triglycerides has
Although the causes for obesity are unclear it
recently has recently been recognized as a
seems that environmental, genetic, neural and
public health concern. While the metabolic
endocrine factors contribute to its
syndrome alone is a condition of disabling
development. The rapid global spread of
medical sequel, it is an intermediary step in the
obesity resembles epidemiologically the
progression of a number of vascular and
spread of an infectious disease. Surprisingly,
coronary-related clinical events. Observational
little consideration has been given to the
evidence suggests that central obesity is a key
possibility that the epidemic of obesity could be
element of the metabolic syndrome, and recent
due to an infectious agent.
studies suggest an etiologic role for visceral
adipose tissue.
However, in animals, seven viruses and a
scrape agent have shown to cause obesity,
For several years it has been known that a
and adenoviruses Ad-31 and Ad-9 have been
waist line circumference of ? 80 cm in females
shown to be radiogenic in animal cell cultures.
and ? 94 cm in males have been proposed to
In humans, small EDRK-rich factor 1A (SMAM-
be used as a clinical cardiovascular risk
1), an avian adenovirus 36 (Ad-36).Studies
assessment and interpretation of health risks,
have conformed that humans as well as
animals with obesity can have infections. In

order to treat such infections the search for
suitable agents has started.
Even if big resources have been used on
research and treatment of obesity during the
last decades the results have been
disappointing according to reports from WHO.
We have not been able to reduce the epidemic
dimension of overweight and obesity in the
way we have approached the problem.
Different alternative ways should be tried in
order to solve the problems.
Obesity is generally considered as the end
result of a long standing positive energy

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From the literature there is also evidence to
body’s natural weight-control mechanisms. It
indicate that the body’s natural weight –control
might be that these effects , together with a
mechanisms are not functioning properly in
wide range of additional, possibly synergistic
obesity. Because the obesity epidemic
factors may play a significant role in the
occurred relatively quickly it has been
worldwide obesity epidemic.
suggested that environmental causes instead
of genetic factors may be largely responsible.
Certain criteria have to be met for such agents
What has, up to now, been overlooked is that
that shall be used for long-term treatment.
earth’s environment and usage of has changed
Based on favorable clinical pilot experiences
significantly during the last decades because
with a combination of a mixture of herbs and 1,
of the exponential production and usage of
3-1, 6 beta glucan in reducing fat deposits we
synthetic organic and inorganic chemicals.
decided to carry out a placebo controlled
Many of these chemicals are better know for
blinded study
causing weight loss at high levels of exposure
Here we present the results of a clinical trial in
but much lower concentrations of these
Norwegian females using a preparation
chemicals have powerful weight –promoting
containing 1, 3-1, 6 beta glucan and a
actions. This property has already been widely
combination of different herbs. The
exploited commercially to produce growth
composition is described below (Material and
hormone that fatten livestock and
Methods). The primary outcome was
pharmaceuticals that induce weight gain in
decreased weight, BMI, waist, stomach and hip
grossly underweight patients. One hypothesis
circumferences as well as tolerability.
is therefore that the current level of human
exposure to these chemicals may have

damaged many of the boy’s natural weight-
control mechanisms. It might be that these

exposures may have damage many of the

Subjects and Methods


Subjects

Female subjects with slight to moderate
Study design
overweight (BMI ?27.5 kg/m2) were invited to
The study was carried out as placebo
participate in the study. All participants gave
controlled single blind study in the following
written informed consent before entering the
way. Twelve of the participants started the
study, after having received information about
study with a 30 day placebo period. They were
the study procedures. The study was
controlled initially and then after 30 days. At
conducted according to the principles of the
conclusion of the placebo period they were
revised Declaration of Helsinki, Good Clinical
switched to the active preparation for a period
Practice and local regulation.
of 30 days. Another group of 16 participants
Participants should not use any drugs for
started at the same directly on treatment with
chronic diseases or be on any weight reduction
the active treatment. In this way 28 participants
treatment. No diets advice or advices with
were receiving the active treatment for a period
respect to exercise were given to the
of 30 days. All the subjects were then
participants before inclusion in the study. In
controlled after 30 days on active treatment.
this short –time study we were interested to
study the effect of the preparation when other
factors were kept unchanged.

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Treatment
contained lactose. All tablets used in this study
were supplied by Med –Eq AS ,Tønsberg,
The investigational preparation used in this
Norway.
study was 30 Days® from Med-Eq AS. The
product is defined as a food supplement and
Performance of the study
each tablet contains the following ingredients:
125 mg 1.3-1.6 ?-glucan extract from brewer’s
Initially and after 30 days (end of the study) the
body weight of the subject was registered on a
yeast and 50 mg water extracts (1:10) of each
balance beam medical scale to the nearest 0.1
the following herbs, blessed milk thistle
kg. Stature was measured initially on a
(Silybum marianum), golden root (Rhodiola
portable stadiometer to an accuracy of 0.5cm
rosea), global artichoke (Cynara
with the subject barefoot, feet together and
scolymus),schisandra (Schisandra chinensis),
head level. Other parameters measured at
licorice root (Glycyrrhiza glabra) and dandelion
each visit included waist, abdominal and hip
(Taraxacum).
circumferences.
Body composition was measured initially and
The mixture of these herbs, which all have a
at the end of the study Body composition was
specific effect on gastrointestinal function
determined with bio-impedance
through a detoxification effect.
measurements.
The dosage was two tablets in the morning

and two tablets in the evening. The tablets
were taken together with food and swallowed
Statistical evaluation
with water. The choice of daily dose was based
on the clinical experience made pre-trial. No
Data are given in the text and tables as means
formal dose-response studies have been
± standard deviations (SDs). Data were
carried out. The total daily dose was thus 500
analyzed with SAS statistical package version
mg 1.3-1.6 ?-glucan and 1200 mg of the herb
8.2 and SPSS software 13.0 for Windows. In
mixture. The placebo tablets used in the study
all analyses a two –sided p value of 0.05 was
considered statistically significant.
Results
The results from this study are presented in the following tables1 and 2. As can be seen from table 1
both the body weight(BW),body mass index BMI and the body fat BF% were reduced significantly
during the study period of 30 days when the subjects were taking the active preparation (30 Days®).
For the 12 patients starting with a 30 days treatment with placebo no statistical differences were seen
in any of the parameters.
The average weight reduction in this study is 1.8 kg giving a weekly weight reduction of approximately
0.5 kg. The average waist reduction is 3.8 cm, while the abdominal circumference
Most of the subjects participating in this study reported that their gastrointestinal functions were
normalized after starting taking the active preparation. Quite a few of the participants had suffered
from constipation before entering the study. After starting the study the constipation disappeared and
they had an improved gastrointestinal function during the study and felt much better in that respect.
The tolerability of the treatment was excellent and none of the participants had any problems with
side-effects of the active treatment during the study period.

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Discussion
The results from this study indicate that the preparation used has a very favorable effect on reducing
fat deposits documented through the quite impressing reduction of waist circumference of 3.8 cm and
similar reductions in abdominal and hip circumferences.
The reduction of body weight is also quite satisfactory, and it is impressing that almost 100% of the
weight loss is due to fat loss
The combination of 1.3 -1.6 ?-glucan and the mixture of herbs might be a good treatment for metabolic
syndrome which today is renamed systemic inflammatory response syndrome (SIRS). Obesity creates
a low-grade SIRS that is similar (but on a smaller scale) to gram-negative sepsis. This process
involves up-regulation of systemic immunity, is characterized clinically by insulin resistance and
metabolic syndrome, and put the subject at increased risk for organ failure, infectious morbidity and
mortality. Through lipotoxicity and cytokine dysregulation , obesity may act to prime the immune
system, and predisposing to an exaggerated subsequent immune response when a second clinical
insult occurs (such as trauma, burns, or myocardial infarction), Specialized nutrition therapy for such
patients currently consist of hypocaloric,high protein diet. However, this approach does not address
the putative pathophysiological mechanisms of inflammation and altered metabolism associated with
obesity. A number of dietary agents such as arginine, fish oil , and carnitine may correct these
problems at the molecular levels. Pharmaconutrition formulas may provide exciting innovation for the
nutrition therapy of the obese patient.
?-glucan has been studied for over twenty years for their favorable biological effects in mammals. It is
common knowledge in the scientific community that ?-glucan is the most known powerful immune
stimulant and a very powerful antagonist to both benign and malignant tumors; it lowers cholesterol
and triglyceride levels ,normalizes blood sugar level, heals and rejuvenates the skin and has various
other benefits.
In recent study it was shown that consumption of a diet high in ?-glucan reduced the visceral fat area,
waist circumference as well as the serum low-density lipoprotein cholesterol (LDL-C) and total
cholesterol (TC) in hypercholesterolemic Japanese men.
By recognizing the role of toxins in obesity and altered function of the neuroendocrine –immune and
the mitochondrial and redox systems, and by creating a comprehensive strategy for both reduction of
exposure to and elimination of toxins, as well as the development of effective clinical strategies,
treatment resistance to obesity may be more successfully addressed. Further research is needed to
explore the clinical relevance and the mechanisms that underlie this hypothesis and to examine
clinical detoxification methods.

The favorable results obtained with the food supplement used in this pilot study on fat deposits should
be followed up on a larger group of participants where also serum concentration of lipids should be
followed. It would also to be interesting to study the long-term effect of the treatment with this food
supplement product.
In conclusion, intake of the food supplement used in this study significantly and safely reduced body
weight, body fat and body mass index as well as waist, abdominal, and hip circumferences. The
preparation seems to have beneficial effects in preventing the metabolic syndrome.

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Table 1: Development of BW,BMI and BF% on placebo and active treatment SD
in parentheses. Ns mean no significance.
Group
Parameter Baseline
After 30 days
Diff
p-value
Placebo
BW(Kg)
78.1
78.0

0.1
ns
N=12
BMI(Kg/m2) 28.0
28.0

0.0
ns


BF(%)
39.8
39.8

0.0
ns

Active
BW(Kg)
77.1
75.3

1.8



N=28
BMI(Kg/m2) 28.1
27.5

0.6


BF(%)
39.4
37.9

1.5

Table 2: Development of WC,AC and HC on placebo and active treatment. SD in
parentheses. Ns means no significance.
Group
Parameter Baseline
After 30 days
Diff
p-value
Placebo
WC(cm)
91.0
91.0

0.0
ns
N=12
AC(cm)
96.7
96.8

0.1
ns


HC(cm)
100.3
100.2

0.1
ns

Active
WC(cm)
94.9(7.6)
91.1(7.4)

3.8
p?0.01

N=28
AC(cm)
96.5(8.2)
92.4(7.7)

4.1
p?0.01


HC(cm)
99.7(8.0)
95.7(7.8)

4.0
p?0.01

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