CA2751218C - Weight loss formulation - Google Patents
Weight loss formulation Download PDFInfo
- Publication number
- CA2751218C CA2751218C CA2751218A CA2751218A CA2751218C CA 2751218 C CA2751218 C CA 2751218C CA 2751218 A CA2751218 A CA 2751218A CA 2751218 A CA2751218 A CA 2751218A CA 2751218 C CA2751218 C CA 2751218C
- Authority
- CA
- Canada
- Prior art keywords
- fruit
- weight
- leaf
- mentha
- vitamin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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- A61K31/201—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having one or two double bonds, e.g. oleic, linoleic acids
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- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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- A—HUMAN NECESSITIES
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Abstract
A weight loss product comprises a mixture of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora (in the weight proportion 12:10:5:4), 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, 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 Cambogia, 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. A preferred additional ingredient is caffeine provided by caffeine anhydrous, Coffea Arabica, Coffea canephora, Camellia sinensis, Ilex paraguariensis, Guarana, Theobroma cacao, and kola nut. Other additional ingredients may be used as well in accordance with specific disclosed formulations.
Description
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 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
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 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
2 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,
[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,
3 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,
[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,
4 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 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 , 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 [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 [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 [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 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)) 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:
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 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.
[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 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 , 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 [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 [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 [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 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)) 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:
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 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.
Claims (10)
1. A weight loss composition comprising Alchemilla vulgaris, Olea europaea, Cuminum cyminum, Mentha longiflora, caffeine anhydrous, Vitamin C, Lyceum barbarum, Malpighia glabra, Blueberry, Punica granatum, Bilberry, and one or more excipients.
2. The weight loss composition of claim 1, characterized by the following respective weight percentages:
% (wt.) of total (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 12.142498 Cuminum cyminum seed, and Mentha longtflora leaf (ii) caffeine 7.213365 (iii) Vitamin C 0.295267 (iv) Lyceum barbarum ¨ fruit 0.040074 (v) Malpighia glabra ¨ fruit 0.040074 (vi) Blueberry powder ¨ fruit 0.040074 (vii) Punica granatum ¨ fruit and seed 0.040074 (viii) Bilberry ¨ fruit 0.040074 (ix) One or more excipients Remainder.
% (wt.) of total (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 12.142498 Cuminum cyminum seed, and Mentha longtflora leaf (ii) caffeine 7.213365 (iii) Vitamin C 0.295267 (iv) Lyceum barbarum ¨ fruit 0.040074 (v) Malpighia glabra ¨ fruit 0.040074 (vi) Blueberry powder ¨ fruit 0.040074 (vii) Punica granatum ¨ fruit and seed 0.040074 (viii) Bilberry ¨ fruit 0.040074 (ix) One or more excipients Remainder.
3. The weight loss composition of claim 1 characterized by the following amounts by weights:
Weight (g) (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 0.303000 Cuminum cyminum seed, and Mentha longiflora leaf (ii) caffeine 0.180000 (iii) Vitamin C 0.007368 (iv) Lyceum barbarum - fruit 0.000100 (v) Malpighia glabra - fruit 0.000100 (vi) Blueberry - fruit 0.000100 (vii) Punica granatum - fruit and seed 0.000100 (viii) Bilberry - fruit 0.000100.
Weight (g) (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 0.303000 Cuminum cyminum seed, and Mentha longiflora leaf (ii) caffeine 0.180000 (iii) Vitamin C 0.007368 (iv) Lyceum barbarum - fruit 0.000100 (v) Malpighia glabra - fruit 0.000100 (vi) Blueberry - fruit 0.000100 (vii) Punica granatum - fruit and seed 0.000100 (viii) Bilberry - fruit 0.000100.
4. The weight loss composition of any one of claims 1-3, wherein the composition is characterized by the following proportions:
Alchemilla vulgaris - 12 parts by weight;
Olea europaea -10 parts by weight;
Cuminum cyminum - 5 parts by weight; and Mentha longiflora - 4 parts by weight.
Alchemilla vulgaris - 12 parts by weight;
Olea europaea -10 parts by weight;
Cuminum cyminum - 5 parts by weight; and Mentha longiflora - 4 parts by weight.
5. The use of a composition for enhancing weight loss in an individual, wherein the composition comprises Alchemilla vulgaris, Olea europaea, Cuminum cyminum, Mentha longiflora, caffeine anhydrous, Vitamin C, Lyceum barbarum, Malpighia glabra, Blueberry, Punica granatum, Bilberry, and one or more excipients.
6. The use of claim 5, wherein the composition is characterized by the following respective weight percentages:
% (wt.) of total (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 12.142498 Cuminum cyminum seed, and Mentha lonalora leaf (ii) caffeine 7.213365 (iii) Vitamin C 0.295267 (iv) Lyceum barbarum ¨ fruit 0.040074 (v) Malpighia glabra ¨ fruit 0.040074 (vi) Blueberry powder ¨ fruit 0.040074 (vii) Punica granatum ¨ fruit and seed 0.040074 (viii) Bilberry ¨ fruit 0.040074 (ix) One or more excipients Remainder 0.000100.
% (wt.) of total (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 12.142498 Cuminum cyminum seed, and Mentha lonalora leaf (ii) caffeine 7.213365 (iii) Vitamin C 0.295267 (iv) Lyceum barbarum ¨ fruit 0.040074 (v) Malpighia glabra ¨ fruit 0.040074 (vi) Blueberry powder ¨ fruit 0.040074 (vii) Punica granatum ¨ fruit and seed 0.040074 (viii) Bilberry ¨ fruit 0.040074 (ix) One or more excipients Remainder 0.000100.
7. The use of any one of claims 5-6, wherein the composition is characterized by the following proportions:
Alchemilla vulgaris ¨ 12 parts by weight;
Olea europaea ¨ 10 parts by weight;
Cuminum cyminum ¨ 5 parts by weight; and Mentha longiflora ¨ 4 parts by weight.
Alchemilla vulgaris ¨ 12 parts by weight;
Olea europaea ¨ 10 parts by weight;
Cuminum cyminum ¨ 5 parts by weight; and Mentha longiflora ¨ 4 parts by weight.
8. The use of a composition in the manufacture of a medicament for enhancing weight loss in an individual, wherein the composition comprises Alchemilla vulgaris, Olea europaea, Cuminum cyminum, Mentha longiflora, caffeine anhydrous, Vitamin C, Lyceum barbarum, Malpighia glabra, Blueberry, Punica granatum, Bilberry, and one or more excipients.
9. The use of claim 8, wherein the composition is characterized by the following respective weight percentages:
% (wt.) of total (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 12.142498 Cuminum cyminum seed, and Mentha longiflora leaf (ii) caffeine 7.213365 (iii) Vitamin C 0.295267 (iv) Lyceum barbarum ¨ fruit 0.040074 (v) Malpighia glabra ¨ fruit 0.040074 (vi) Blueberry powder ¨ fruit 0.040074 (vii) Punica granatum ¨ fruit and seed 0.040074 (viii) Bilberry ¨ fruit 0.040074 (ix) One or more excipients Remainder 0.000100.
% (wt.) of total (i) a mixture of Alchemilla vulgaris leaf, Olea europaea leaf, 12.142498 Cuminum cyminum seed, and Mentha longiflora leaf (ii) caffeine 7.213365 (iii) Vitamin C 0.295267 (iv) Lyceum barbarum ¨ fruit 0.040074 (v) Malpighia glabra ¨ fruit 0.040074 (vi) Blueberry powder ¨ fruit 0.040074 (vii) Punica granatum ¨ fruit and seed 0.040074 (viii) Bilberry ¨ fruit 0.040074 (ix) One or more excipients Remainder 0.000100.
10. The use of any one of claims 8-9, wherein the composition is characterized by the following proportions:
Alchemilla vulgaris ¨ 12 parts by weight;
Olea europaea ¨ 10 parts by weight;
Cuminum cyminum ¨ 5 parts by weight; and Mentha longiflora ¨ 4 parts by weight.
Alchemilla vulgaris ¨ 12 parts by weight;
Olea europaea ¨ 10 parts by weight;
Cuminum cyminum ¨ 5 parts by weight; and Mentha longiflora ¨ 4 parts by weight.
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