TESKAC PLAJNŠEK KARMEN (SI)
DIMITRIJEVIC DUŠANKA (SI)
GAY THIERRY (FR)
COHEN OHAD OVADYA (IL)
WO2011047321A1 | 2011-04-21 |
US20050249827A1 | 2005-11-10 | |||
US20060159773A1 | 2006-07-20 | |||
KR20070009208A | 2007-01-18 |
PATENT CLAIMS 1. A mixture for reducing body mass containing rosemary leaf extract {Rosmarinus officinalis), green coffee extract {Coffea Canephora robusta P.), black radish root extract (Raphanus sativus), green tea leaf extract (Camelia sinensis), cinnamon bark extract (Cinnamonum cassia Presl) and rose root extract (Rhodiola rosea L.). 2. Mixture according to claim 1 characterized in that the extracts are standardized to the following active ingredients: - rosemary leaf extract: rosemarinic acid; green coffee extract: chlorogenic acid; - green tea leaf extract: polyphenols, epigallocatechin gallate; - cinnamon bark extract: polyphenols; rose root extract: salidrosides, rosavines; -black radish root extract is not standardized. 3. Mixture according to claim 1 characterized by containing 10-60 % by weight of green coffee extract, 5-40 % by weight of green tea extract, 0.5-20 % by weight of rose root extract, 10-60 % by weight of rosemary extract, 1-20 % by weight of cinnamon bark extract and 1-20 % by weight of black radish extract. 4. Mixture according to claim 1 characterized in that a daily dosage of the mixture consists of 380 mg of green coffe extract which corresponds to 170 mg of chlorogenic acids, 100 mg of green tea leaf extract which corresponds to 95 mg of total polyphenols, of that 40 mg of epigallocatechin gallate, 20 mg of rose root extract which corresponds to 0.2 mg of salidrosides and 0.6 mg of rosavines, 400 mg of rosemary extract which corresponds to 60 mg of rosemarinic acid, 50 mg of cinnamon bark extract which corresponds to 10 mg of polyphenols, and 50 mg of black radish extract. 5. Mixture according to claim 4 characterized in that the daily dosage is divided into a daily and a night capsule. 6. Mixture according to claim 5 characterized in that the daily capsule contains extracts of green coffee, green tea leaves and rose root. 7. Mixture according to claim 5 characterized in that the night capsule contains the extracts of rosemary leaves, cinnamon bark and black radish. 8. Mixture according to claims 1 do 7 for use in reducing body mass, reducing waist size, reducing blood pressure, regulating heartbeat, reducing blood lipids and glucose, improving mood, improving sleep and reducing the feeling of hunger and appetite. |
The object of the invention is a mixture used as a dietary supplement for reducing body mass. The mixture includes six plant extracts: rosemary leaf extract (Rosmarinus officinalis), green coffee extract (Coffea Camphor a robusta P.), black radish root extract (Raphanus sativus), green tea leaf extract (Camelia sinensis), cinnamon bark extract (Cinnamonum cassia Presl) and rose root extract (Rhodiola rosea L.). The mixture not only contributes to the reduction of body mass but also contributes to a reduced waist size, improved cardiovascular parameters, such as blood pressure reduction, heart beat regulation, blood lipid and glucose reduction as well as to improved personal aspects, such as improved mood, better sleep, reduced feeling of hunger and appetite. ·
There are many dietary supplements in the market that are used to regulate body mass. They have a disadvantage that they are primarily limited to one active ingredient and this fails to provide satisfactory results in regulating body mass.
The task and goal of the invention is therefore to prepare a mixture that will be used as a dietary supplement for reducing body mass and will include various mechanisms of regulating body mass such as:
- influence on appetite,
- influence on glucose absorption and consequently accumulation of glucose in fat cells, influence on metabolism,
- influence on absorption enzymes,
- detoxification of organism,
- thermogenesis or fat burning effect, and
antistress activity.
The task of the invention is solved by a mixture including six plant extracts: rosemary leaf extract (Rosmarinus officinalis), green coffee extract (Coffea Canephora robusta P.), black radish root extract (Raphanus sativus), green tea leaf extract (Camelia sinensis), cinnamon bark extract (Cinnamonum cassia Presl) and rose root extract (Rhodiola rosea L.).
The extracts are standardized to following active ingredients: 1. The rosemary extract contains at least 15 % by weight of rosemarinic acid.
2. The green coffe extract contains at least 45 % by weight of chloro genie acids.
3. The green tea leaf extract contains at least 95 % by weight of polyphenols, of that at least 40 % by weight of epigallocatechin gallate.
4. - The cinnamon bark extract contains at least 20 % by weight of polyphenols.
5. The rose root extract contains at least 1 % by weight of salidrosides and at least 3 % by weight of rosavines.
The black radish root extract is not standardized.
The mixture contains 10-60 % of green coffee extract, 5-40 % of green tea extract, 0.5-20 % of rose root extract, 10-60 % of rosemary extract, 1-20 % of cinnamon bark extract and 1- 20 % of black radish extract. The indicated percents are the percents by weight. The content of active ingredients in the mixture is standardized in a way that a daily dosage of the mixture contains 100-300 mg of chlorogenic acids, 40-120 mg of total polyphenols, of that 20-60 mg of epigallocatechin gallate, up to 2 mg of salidroside and 6 mg of rosavines, 10-150 mg of rosemarinic acid, 2-30 mg of cinnamon polyphenols and 20-30 mg of black radish extract.
A daily dosage of the mixture preferably contains 380 mg of green coffee extract which corresponds to 170 mg of chlorogenic acids; 100 mg of green tea leaf extract which corresponds to 95 mg of total polyphenols, of that 40 mg of epigallocatechin gallate; 20 mg of rose root extract which corresponds to 0.2 mg of salidrosides and 0.6 mg of rosavines; 400 mg of rosemary leaf extract which corresponds to 60 mg of rosemarinic acid; 50 mg of cinnamon bark extract which corresponds to 10 mg of polyphenols, and 50 mg of black radish extract.
A daily dosage is divided into a daily capsule containing the extracts of green coffee, green tea leaves and rose root, and a night capsule containing the extracts of rosemary leaves, cinnamon bark and black radish root. The daily and night capsules are composed based on the mechanism of activity. A daily capsule reduces appetite, reduces glucose absorption and accumulation of glucose in fat cells, improves metabolism and has antistress activity. The antistress component is added due to a reduced intake of calories while a person is losing weight and a human organism can react by stress. A night capsule accelerates detoxification of an organism, inhibits the activity of absorption enzymes and increases thermogenesis (fat burning effect).
The extracts in the mixture have the following effects on the body weight regulation:
- green coffee extract reduces appetite, reduces glucose absorption and accumulation of glucose in fat cells;
- green tea leaf extract improves metabolism;
- extracts of rosemary and black radish detoxicate the organism and inhibit absorption enzymes;
cinnamon bark extract increases thermogenesis, it has a fat burning effect,
rose root extract has antistress activity.
The invention will be described by way of embodiments and drawings representing in:
Figure 1: Positive effects of taking the extract mixture in comparison with placebo in women.
Figure 2: Positive effects of taking the extract mixture in comparison with placebo in men.
EMBODIMENT 1
A mixture of extracts according to Table 1 was prepared.
Table 1: Composition and features of a mixture for body weight regulation.
Rosemary Green Black Green tea Cinnamon Rose root extract coffee radish extract extract extract extract extract
Plant variety Rosmarinus Coffea Raphanus Camellia Cinnamomu Rhodiola officinalis Canephora sativus L, sinensis m cassia Rosea L.
robusta P. Presl
Plant parts leaves grain root leaves bark root used
Extraction acetone, water water ethyl acetate, water ethanol, solvent water water, water
acetone
Plant
material:extrac 25-35: 1 7: 1 8: 1 50-55: 1 10: 1 3-4: 1 t ratio
Content of > 15 % by > 45 % by / > 95 % by > 20 % by > 3 % by active weight of weight of weight of weight of weight of ingredients rosemarinic rosemarinic polyphenols, polyphenols rosavines acid acid of that > 1 % by
> 40 % by weight of weight of salidrosides epigallocatec
hin gallate
Percentage of
extract in final
mixture 40 % by 38 % by 5 % by 10 % by 5 % by 2 % by weight weight weight weight weight weight
Percentage of
caffeine in
final mixture < 10 % by weight
The prepared mixture was tested »in vitro« as to its capability of inhibiting differentiation of fat cells (adipocytes), wherein human fat cells were used as a model (the assay was performed in the BlOalternatives Laboratory, France, study number: AX11 1202, august 2012). The mixture for regulating body weight inhibited differentiation of fat cells by 46 % compared to a control sample (p<0.01).
EMBODIMENT 2
Two mixtures were prepared which correspond to a daily and a night capsule in accordance with Table 2.
Table 2: Composition of daily and night dosages for performing mutagenicity and citotoxicity assays.
The mutagenic activity of the extract mixture in the daily and night capsules was determined by the Salmonella microsome reverse mutation assay (Ames assay) with a standard assay of plate incorporation (Maron in Ames, 1983). The test was performed on two strains of bacteria Salmonella typhiamrium TA98 and TA100 (Trinova Biochem GmbH, Germany) in the presence and absence of the metabolic activation S9 (4 %) following OECD guidelines 471. The concentrations tested with the Ames assay were 0, 0.03125, 0.0625, 0.125, 0.25 and 0.5 mg/plate. 50 % ethanol was used as a solvent.
Both samples, the daily and the night capsules, on both strains, with and without activation, were negative. This means that the extract mixtures in the daily and night capsules do not have a mutagenic activity.
The cytotoxic and genotoxic activity of the extract mixture in the daily and night capsules was determined by the MTT cytotoxicity assay (Mosmann, 1983) and with the microcore assay (Fenech, 2006) (following the OECD guidelines 487) on a human hepatoma cell line (HepG2 cells; source: Dr. Firouz Darroudi, Department of Toxicogenetics, the University of Leiden, the Netherlands). HepG2 cells have preserved some metabolic enzymes of Phase I and II of xenobiotic metabolism and are therefore a useful model for detecting the genotoxic activity of pro-genotoxins.
MTT assay was used to determine the cytotoxic activity of the extract mixture in the daily and night capsules (0, 0.03125, 0.0625, 0.125, 0.25 and 0.5 g/ml) after 24-hour exposure of cells.
Both assays have confirmed that the extract mixtures in the daily and night capsules do not have cytotoxic and genotoxic activities.
EMBODIMENT 3
The extract mixture in the form of both the daily and night capsules was tested in an extensive clinical trial carried out in compliance with Good Clinical Practice (Effect of a dietary supplement on body mass reduction in overweight persons with a simultaneous reduction in daily intake of supplements and exercise at least three times a week). The clinical trial was randomized, double blind, placebo controlled, multi-centre. The trial took 14 weeks. It included 167 participants, women and men, aged from 18 to 65 and having overweight (body mass index (BMI): 25 kg/m2 - 30 kg/m2).
The extract mixture has proved to be safe as it even had less side effects compared to the placebo. The results of the clinical trial are as follows:
Comparison of efficiency of the extract mixture and the placebo
In comparison with the participants who were given the placebo, the extract mixture helped both women and men in reducing their body mass, reducing waist size and improving some cardiovasular parameters, and also in improving their mood, sleep and reducing appetite and hunger.
The mosts considerable body mass loss was noticed in women, especially in those having a higher BMI (27.5-30 kg/m2), wherein as much as 42 % of women who took the extract mixture lost an average of 3.0 kg, whereas the women in the control group lost an average of 1.5 kg.
The extract mixture also had positive cardiovascular effects. Compared to the control group, as much as 14 % of the women who were given the extract mixture, experienced reduction in the bottom blood pressure by an average of 2.1 mm Hg, while the bottom blood pressure in the control group was reduced by an average of merely 0.6 mm Hg.
48 % more women, especially those with a lower BMI (25-27.5 kg/m2), who were given the extract mixture, had a reduced heartbeat. In these women, the heart beat slowed down by an average of 3.9 beats/min, while it even increased by an average of 0.8 beats/min in the control group.
51 % of women, especially those having a lower BMI (25-27.5 kg/m2), who were given the extract mixture, experienced improved mood compared to the control group. 48 % of women, especially those having a lower BMI (25-27.5 kg/m2), who were given the extract mixture, experienced better sleep compared to the control group.
The extract mixture helped the men, especially those having a lower BMI (25-27.5 kg/m2), reduce the body mass. 20 % more men from the mentioned group lost an average of 2.1 kg, while the men in the control group lost an average of merely 1.7 kg. Compared to the control group, 14 % more men who were given the extract mixture reduced their waist size. The men who were given the extract mixture have lost an average of 3.9 cm, while those in the control group have only lost 2.4 cm. Like the women, the men who were given the extract mixture also experienced the improvement in their bottom blood pressure, a three-fold improvement. While the men, especially those having a higher BMI (27.5-30 kg/m2) who were given the extract mixture experienced reduced bottom blood pressure by an average of 4.7 mm Hg, those in the control group even experienced an increased bottom blood pressure by an average of 0.1 mm Hg. The men, especially those having a higher BMI (27.5 kg/m2 - 30 kg/m2) who were given the extract mixture, experienced reduced appetite and hunger. Compared to the control group, 41 % more men who were given the extract mixture experienced reduced appetite and the hunger was reduced in 55 % more men.
The results are shown in Figure 1 and 2.
Efficiency of the extract mixture in the participants weighing from.86 to 95 kg
The trial has shown that the extract mixture significantly contributed to the reduction in body mass especially in those persons weighing from 86 to 95 kg. The participants who were given the extract mixture experienced a reduction in body mass by an average of 2.6 kg, while the control group experienced a body mass loss by an average of merely 0.5 kg (p=0.047).
The group who was given the extract mixture experienced a significant reduction in the bottom blood pressure, even by an average of 3.9 mm Hg, while the participants in the control group even experienced an increased bottom blood pressure by an average of 5.2 mm Hg (p=0.02). The heartbeat of the participants who were given the extract mixture slowed down by an average of 4.5 beat/min, while the participants in the control group even experienced a pulse increased by 2.1 beats/min (p=0.02). The extract mixture also improved sleep (p=0.04) and helped improve caloric intake by 26.7 %, while the participants in the control group failed to reduce their caloric intake (p=0.04).