Note: Descriptions are shown in the official language in which they were submitted.
WEIGHT LOSS FORMULATION
CROSS-REFERENCE TO RELATED APPLICATION
pm11
BACKGROUND OF THE INVENTION
[oon] Field of the Invention
[0003] The present invention relates to a weight loss formulation, and more
particularly, to a formulation comprising a known combination of herbal
extracts to which is added further ingredients to enhance weight loss,
[0004] Description of Related Art
[0005] A product called WeighlevelTM marketed by Sprunk-Jansen A/S contains a
mixture of the extracts of four plants that have been used in traditional folk
medicine as a weight loss product. The four plants are Lady's Mantle
(Alchemilla vu/guns L.), olive leaves (O/ea europaea L.), cumin seed
(Cuminum cyminum L.), and wild mint (Mentha longiflora L .). Reported
studies have demonstrated the efficacy for weight loss of a daily regimen of
three 310 mg tablets taken with meals, each tablet containing the following
amounts of these plant extracts:
Alchemilla vulgaris - 60 mg
Oka europaea. - 50 mg
Cuminum cyminum - 25 mg
Mentha longiflora.- 20 mg
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Said, 0., et al., "Weight Loss in Animals and Humans Treated with
'Weighlevel,' a Combination of Four Medicinal Plants Used in Traditional
Arabic and Islamic Medicine," Evid Based Complement Alternate Med, Vol. 5,
pgs. 421-28 (2008); Said, 0.,
et al., "A Double Blinded-Randomized Clinical Study with 'Weighlevel,' a
Combination of Four Medicinal Plants Used in Traditional Arabic and
Islamic Medicine," The Open Complementary Medicine Jour., Vol. 2, pgs. 1-6
(2010). (The formulations in both studies also contained 7 mg of Vitamin C
and 148 mg of tricalcium phosphate).
[0006] However, there appear to be no reports of enhancing the weight loss
effects
of the tested WeighlevelTM herbal formulation by incorporating other
ingredients in combination with extracts of Alchernilla vulgaris, Olea
europaea, Cuminum cyminum, and Mentha longlflora.
SUMMARY OF THE INVENTION
[0007] It is an object of the present invention to provide various
formulations of
the above combination of Alchemilla vulgaris, Olea europaea, Cumin=
cyminum, and Mentha longiflora, with one or more additional ingredients to
enhance weight loss.
[0008] It is a further object of the invention to provide methods of
administering
such formulations to enhance weight loss in individuals using them.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0009] The present invention includes numerous specific formulations that
comprise Alchemilla vu/guns, Olea europaea, Cuminum cyminum, and
Mentha longiflora, to which additional ingredients have been added to
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increase the weight loss efficacy of previously known products such as
WeighlevelTM.
[0010] It is believed that the use of Alchemilla vulgaris, Olea europaea,
Cuminum
cyminum, and Mentha longiflora, particularly in combination with other
ingredients such as those used in formulations according to the present
invention, may further enhance weight loss in overweight but otherwise
healthy individuals. That is, the studies reported in the Said et al. papers
mentioned above included a large proportion of subjects on medications
for ischemic heart disease, diabetes mellitus, and/or hypertension. Said et
al. 2008 at page 7; Said et al. 2010 at page 3. It is possible that such
medications interfere with the efficacy of such formulations in maximizing
weight loss.
[0011] In addition, there is evidence that a formulation including Alchemilla
vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora in
combination with other ingredients according to the present invention will
cause subjects to lose more weight over the same period than the
WeighlevelTM product reported in the Said et al. papers. It is also believed
that weight loss is even further enhanced in female subjects.
[0012] Formulations according to embodiments of the invention comprise a
mixture of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and
Mentha longiflora, to which additional ingredients have been added to
increase weight loss efficacy. The additional ingredients may include, but
are not limited to, Gamma-oryzanol, Caffeine, Cirsimarin, Fucoxanthin,
Guggulsterones, Evodiamine, Forskolin, Sclareolide, Chromium,
Hydroxycitric acid, Pinolenic acid, Conjugated linoleic acid, Potato protein,
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Raspberry ketone, Capsaicin, Synephrine, Dehydroepiandrosterone,
Phenylethylamine, Orlistat, Glucomannan, or Vitamin C, or sources thereof,
as well as herbal ingredients such as Guarana, Yerba Mate, Damiana, Green
tea, Green coffee bean, Cinnamon, White kidney bean, Garcinia Cam bogia,
Nopal Cactus, Hoodia, Yohimbine, Malpighia glabra, Eurycoma Longifolia,
Caralluma Fimbriata, Citrus aurantium, Gymnema Sylvestre, Lyceum
barbarurn, Aloe Vera, Cayenne, Pomegranate, Blueberry, Billberry, or
extracts of such herbal ingredients, and plant sources of antioxidants. Other
ingredients may be used as well in accordance with the specific
embodiments disclosed hereinbelow.
[0013] Preferably, one of the additional ingredients includes caffeine or a
source
thereof. Suitable sources of caffeine include caffeine anhydrous, Coffea
Arabica, Coffea canephora, Camellia sin ensis, Hex paraguariensis, Guarana,
Theobroma cacao, and kola nut.
[0014] Other embodiments include specific formulations that comprise a mixture
of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha
longiflora, with additional ingredients to enhance weight loss, and further
comprising vitamins, minerals, amino acids, and other nutrients which are
commonly known in the art.
[0015] In all of the specific formulations of the invention described herein,
the
form specified (capsules, caplets, or tablets) were made by requesting a
commercial supplier to manufacture the capsules, caplets, or tablets from
the ingredients listed under each formulation using methods well known to
those skilled in the art of medication and dietary supplement manufacture.
That is, one skilled in such art will be able to make the capsules, caplets,
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and tablets described below without further explanation. In all cases, the
particular excipients are chosen by the supplier to provide the desired
form. Formulations according to the invention may also be in the form of a
powder to be mixed with water and consumed as a beverage. One or more
flavoring agents may be added to the powder as desired.
[0016] Specific Embodiments
[0017] In all of the following formulations, the weight and weight percentage
of in
the tables is stated per the recommend serving size for each formulation. In
all cases, the Lady's Mantle (Alchemilla vulgaris), olive leaves (Olea
europaea), cumin seed (Cuminum cyminurn), and wild mint (Mentha
longiflora) are present in the same proportions to each other as set forth
the two Said articles noted above. That is, the proportions of these four
ingredients in all cases are:
Alchemilla vulgaris - 12 parts by weight
Olea europaea - 10 parts by weight
Cumin urn cymin urn - 5 parts by weight
Mentha longiflora - 4 parts by weight
[0018] Formulation No. 1
[0019] A formulation was prepared with the following ingredients:
Ingredient Amount (g) % (Wt.) of
total
Lady's mantle extract (as Alchemilla vulgaris) 0.303000 20.209323
- leaf
Olive extract (as Olea europaea)- leaf
Cumin extract (as Cuminum cyminum) - seed
Horsemint extract (as Mentha longiflora) - leaf
CA 02751218 2011-08-31
Ingredient Amount (g) % (wt.) of
total
Vitamin C (ascorbic acid) - granular 0.007370 0.491560
Niacin Fine USP FCC (nicotinic acid) 0.004061 0.270858
Calcium D-pantothenate USP (vitamin B5) 0.002188 0.145934
Para-amino-benzoic acid 0.001000 0.066697
Vegetable oil phytosterols 0.001000 0.066697
Vitamin B6 - Pyridoxine HCI 0.000488 0.032548
Vitamin B2- Riboflavin USP 0.000347 0.023144
Vitamin B1- Thiamine HCI 0.000306 0.020409
Vitamin B12- Cyanocobalamin 1% on 0.000120 0.008004
dicalcium phosphate
Excipients Remainder
[0020] This formulation was prepared in the form of powder capsules. The
recommended serving size is two capsules. It is expected that users will
take three servings per day.
[0021] Formulation No. 2
[0022] A formulation was prepared with the following ingredients:
Ingredient Amount (g) % (wt.) of
total
Lady's mantle extract (as Alchemilla vulgaris) 0.303000
16.868269
-leaf
Olive extract (as Olea europaea) - leaf
Cumin extract (as Cuminum cyminum) - seed
Horsemint extract (as Mentha longiflora) - leaf
Caffeine anhydrous USP 0.225000 12.525943
Ferrous gluconate dehydrate 0.017245 0.960044
Vitamin C (ascorbic acid) - granular 0.007143 0.397657
Folic acid - 10% trituration 0.003330 0.185384
Gamma-oryzanol 0.001000 0.055671
L-orthinine monohydrochloride 0.001000 0.055671
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,
Ingredient Amount (g) %
(wt.) of total
L-carnitine L-tartrate 0.001000 0.055671
Excipients Remainder
[0023] This formulation was prepared in the form of liquid capsules. The
recommended serving size is two capsules. It is expected that users will
take three servings per day.
[0024] Formulation No. 3
[0025] A formulation was prepared with the following ingredients:
Ingredient Amount (g) %
(wt.) of total
Lady's mantle extract (as Alchemilla vulgaris) 0.303000 17.740597
¨leaf
Olive extract (as Olea europaea)¨ leaf
Cumin extract (as Cuminum cyminum)¨ seed
Horsemint extract (as Menthe longiflora)¨ leaf
Caffeine anhydrous USP 0.225000 13.173711
Sesame oil ¨ RBDW 0.200000 11.709965
Calcium carbonate (heavy) 0.150000 8.782474
Ferrous gluconate dihydrate 0.017245 1.009692
Vitamin C (ascorbic acid) ¨granular 0.007143 0.418221
Folic acid ¨ 10% trituration 0.002000 0.117100
L-glutamic acid HCI 0.001000 0.058550
L-alanine 0.001000 0.058550
L-isoleucine 0.001000 0.058550
L-serine 0.001000 0.058550
L-threonine 0.001000 0.058550
Coenzyme Q10 0.001000 0.058550
L-glutathione reduced 0.000005 0.000293
Excipients Remainder
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[0026] This formulation was prepared in the form of liquid capsules. The
recommended serving size is two capsules. It is expected that users will
take three servings per day.
[0027] Formulation No. 4
[0028] A formulation was prepared with the following ingredients:
Ingredient Amount (q) % (wt.) of total
Lady's mantle extract (as Alchemilla vulgaris) 0.303000 6.046005
- leaf
Olive extract (as Olea europaea)- leaf
Cumin extract (as Cuminum cyminum)- seed
Horsemint extract (as Mentha longiflora)- leaf
Caffeine anhydrous USP 0.180000 3.591686
Vitamin C (ascorbic acid) - granular 0.007143 0.142530
Carbonyl iron 0.006122 0.122157
Niacin Fine USP FCC (nicotinic acid) 0.004060 0.081012
Calcium D-pantothenate USP (vitamin B5) 0.002188 0.043659
Anise powder (Pimpinella anisum) - seed 0.001000 0.019954
Evening Primrose oil powder (Oenothera 0.001000 0.019954
biennis)- seed
Inosine anhydrous 0.001000 0.019954
Ornithine alphaketoglutarate 1:1 0.001000 0.019954
Papain 12,000 USP unitslmg 0.001000 0.019954
Papaya powder (Carica papaya) - fruit 0.001000 0.019954
Sweet fig powder (Ficus opposita)- fruit 0.001000 0.019954
Folic acid - 10% trituration 0.000800 0.015963
Vitamin 66- Pyridoxine HCI 0.000488 0.009737
Vitamin B2- Riboflavin USP 0.000347 0.006924
Vitamin B1-Thiamine HCl 0.000306 0.006106
Vitamin B12- Cyanocobalamin 1% on 0.000120 0.002394
dicalcium phosphate
Excipients Remainder
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[0029] This formulation was prepared in the form of liquid capsules. The
recommended serving size is three capsules. It is expected that users will
take three servings per day.
[0030] Formulation No. 5
[0031] A formulation was prepared with the following ingredients:
Ingredient Amount (g) % (wt.) of total
Caffeine anhydrous USP 0.200000 9.708738
Lady's mantle extract (as Alchemilla vulgaris) 0.155000 7.524272
¨ leaf
Olive extract (as Olea europaea)¨ leaf
Cumin extract (as Cuminum cyminum) ¨ seed
Horsemint extract (as Menthe tongiflora) ¨ leaf
Vitamin C (ascorbic acid) ¨ granular 0.007000 0.357259
Bee propolis powder 0.001000 0.048488
Boldo (as Peurmus boldus) ¨ leaf 0.001000 0.048488
Feverfew (as Tanacetum parthenium) 0.001000 0.048488
Vitamin B1¨Thiamine Ha 0.001300 0.063107
Vitamin B2¨ Riboflavin USP 0.001600 0.077670
Calcium D-pantothenate USP (vitamin B5) 0.007000 0.339806
Vitamin B6 ¨ Pyridoxine HCI 0.001800 0.087379
Folic acid ¨ 10% trituration 0.000110 0.005340
Vitamin B12¨ Cyanocobalamin 1% on 0.000002 0.000090
dicalcium phosphate
Excipients Remainder
[0032] This formulation was prepared in the form of caplets. The recommended
serving size is two caplets. It is expected that users will take three
servings
per day.
[0033] Formulation No. 6
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[0034] A formulation was prepared with the following ingredients:
Ingredient Amount (g) % (wt.) of
total
Lady's mantle extract (as Afchemilla vulgaris) 0.303000
12.142498
¨leaf
Olive extract (as Olea europaea)¨ leaf
Cumin extract (as Cuminum cyminum)¨ seed
Horsemint extract (as Mentha longiflora) ¨ leaf
Caffeine anhydrous USP 0.180000 7.213365
Vitamin C (ascorbic acid) ¨ granular 0.007368 0.295267
Goji extract (Lyceum barbarum) ¨fruit (std.) 0.000100 ..
0.040074
Acerola extract (concentrate 4-5:1) (Melpighia 0.000100
0.040074
&bra) ¨ fruit
Blueberry powder (Vaccinium corymbosum)¨ 0.000100 0.040074
fruit
Pomegranate powder (Punica granatum) ¨ 0.000100 0.040074
fruit and seed
Bilberry extract 4:1 (Vaccinium myrtillus) ¨ fruit 0.000100 ..
0.040074
Excipients Remainder
[0035] This formulation was prepared in the form of tablets. The recommended
serving size is two tablets. It is expected that users will take three
servings
per day.
[0036] In tests using this formulation 13 subjects (eight females and five
males)
took two tablets three times daily with water before meals, for the length of
time indicated in the following table (weights are in pounds), with the
tabulated results:
Subiect Gender Start Wgt. End Wgt. Duration Weight Loss
1 Female 145 122 8 wks., 5 days 23
2 Female 156.6 133.2 8 wks., 5 days
23.4
3 Male 223.4 198.6 9 wks. 24.8
4 Male 203.2 183.6 8 wks., 5 days
19.6
Female 124.4 110 8 wks., 5 days 14.4
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Subject Gender Start Wgt. End Wgt. Duration Weight
Loss
6 Female 148.8 134.2 8 wks., 5 days 14.6
7 Male 189 171.2 8 wks., 5 days 17.8
8 Female 145 119.8 9 wks., 2 days 25.2
9 Female 143.8 127.2 8 wks., 5 days 16.6
Male 190.2 177 8 wks., 5 days 13.2
11 Male 209.4 195.6 8 wks., 6 days 13.8
12 Female 144.2 126.6 9 wks., 1 day 17.6
13 Female 140.6 123.2 8 wks., 5 days 17.4
Average
Overall 166.4 147.8 18.6
Average
Female 143.6 124.5 19.0
Average
Male 203.0 185.2 17.8
[0037] The next table summarizes the average percentage weight loss achieved
by
Formulation No. 6 against results reported in Table 2 of the 2010 Said et al.
paper for a comparable length of time, namely about two months
(percentage weight loss = average weight loss average start weight).
Formulation No. 6 Said 2010
Overall Average 11.2% 6.9%
Female Average 13.2% 7.5%
Male Average 8.8% 6.0%
[0038] The 2008 Said et al. paper reports an overall average percentage weight
loss of 13.2% after three months, but the charts in Figure 5 indicate a lesser
reduction in body mass index after two months than at three months. From
those charts it appears that the body mass index of overweight people
(Figure 5(A)) decreased from 28.5 to 26, or 8.7% (2.5 28.5) after two
months, while the body mass index of obese people (Figure 5(B))
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decreased from 32.1 to 29, or 9.7% (3.1 32.1). This study did not report
separately for males and females.
[0039] Formulation No. 7
[0040] A formulation was prepared with the following ingredients:
Ingredient Amount (g) % (wt.) of
total
Sesame oil 0.715000 16.798853
Lady's mantle extract (as Alchemilla vulgaris) 0.303000 7.118954
¨ leaf
Olive extract (as Olea europaea)¨ leaf
Cumin extract (as Cuminum cyminum) ¨ seed
Horsemint extract (as Mentha longiflora)¨ leaf
Caffeine anhydrous USP 0.225000 5.286352
Vitamin C (ascorbic acid) ¨ granular 0.007143 0.167824
L-Leucine powder 0.001000 0.023495
L-Proline 0.001000 0.023495
L-Methionine 0.001000 0.023495
L-Tyrosine 0.001000 0.023495
Myristic acid 0.001000 0.023495
Trans-ferulic acid 0.001000 0.023495
Cayenne pepper powder (Capsicum 0.000100 0.002349
frutescens)¨ fruit
Excipients Remainder
[0041] This formulation was prepared in the form of liquid capsules. The
recommended serving size is two capsules. It is expected that users will
take three servings per day.
[0042] Formulation No. 8
[0043] A formulation was prepared with the following ingredients:
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Ingredient Amount (q) % (wt.) of
total
Lady's mantle extract (as Alchemilla vulgaris) 0.303000 11.480839
¨ leaf
Olive extract (as lea europaea) ¨ leaf
Cumin extract (as Cuminum cyminum)¨ seed
Horsemint extract (as Mentha tongiflora)¨ leaf
Caffeine Anhydrous USP 0.180000 6.820300
Vitamin C (ascorbic acid) ¨ granular 0.007370 0.279253
Niacin Fine USP FCC (nicotinic acid) 0.004061 0.153874
Calcium D-pantothenate USP (vitamin B5) 0.002188 0.082905
Para-amino-benzoic acid 0.001000 0.037891
Vegetable oil phytosterols 0.001000 0.037891
Vitamin B6¨ Pyridoxine HCI 0.000488 0.018491
Vitamin B2- Riboflavin USP 0.000347 0.013148
Vitamin Bi ¨ Thiamine HCI 0.000306 0.011595
Vitamin B12¨ Cyanocobalamin 1% on 0.000120 0.004547
dicalcium phosphate
Excipients Remainder
[0044] This formulation was prepared in the form of powder capsules. The
recommended serving size is two capsules. It is expected that users will
take three servings per day.
[0045] Formulation No. 9
[0046] A formulation was prepared with the following ingredients:
Ingredient Amount (q) % (wt.) of
total
Liquid Conjugated linoleic acid (CLA) 1.282051 70.867921
Lady's mantle extract (as Alchemilla vulgaris) 0.303000 16.748928
¨ leaf
Olive extract (as Olea europaea)¨ leaf
Cumin extract (as Cuminum cyminum) ¨ seed
Horsennint extract (as Mentha longiflora) ¨ leaf
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Ingredient Amount (g) % (wt.) of
total
Vitamin C (ascorbic acid) ¨ granular 0.003500 0.193469
Excipients Remainder
[0047] This formulation was prepared in the form of soft gelatin capsules. The
recommended serving size is two capsules. It is expected that users will
take three servings per day
[0048] Summary
[0049] Those skilled in the art will readily recognize that the principles
underlying
the present invention has application to a wide variety of compositions
comprising a mixture of Alchernilla vulgaris, Olea europaea, Cumin=
cyminum, and Men tha longiflora and additional ingredients to enhance
weight loss.
[0050] In that connection, only selected preferred embodiments of the
invention
have been depicted and described, and it will be understood that various
changes and modifications can be made other than those specifically
mentioned above without departing from the spirit and scope of the
invention, which is defined solely by the claims that follow.
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