Weight loss formulation

BACKGROUND OF THE INVENTION

1. Field of the Invention

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.

2. Description of Related Art

A product called Weighlevel.TM. 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 vulgaris L.), olive leaves (Olea 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 Olea europaea--50 mg Cuminum cyminum--25 mg Mentha longiflora.--20 mg

Said, O., 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) (available at http://ecam.oxfordjournals.org); Said, O., 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).

However, there appear to be no reports of enhancing the weight loss effects of the tested Weighlevel.TM. herbal formulation by incorporating other ingredients in combination with extracts of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide various formulations of the above combination of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora, with one or more additional ingredients to enhance weight loss.

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

The present invention includes numerous specific formulations that comprise Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora, to which additional ingredients have been added to increase the weight loss efficacy of previously known products such as Weighlevel.TM..

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.

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 Weighlevel.TM. product reported in the Said et al. papers. It is also believed that weight loss is even further enhanced in female subjects.

Formulations according to embodiments of the invention comprise a mixture of Alchemlla 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, 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 Longiflolia, Carailuma Fimbriata, Citrus aurantium, Gymnema Sylvestre, Lyceum barbarum, 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.

Preferably, one of the additional ingredients includes caffeine or a source thereof. Suitable sources of caffeine include caffeine anhydrous, Coffea Arabica, Coffea canephora, Camellia sinensis, Ilex paraguariensis, Guarana, Theobroma cacao, and kola nut.

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.

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, 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.

Specific Embodiments

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 cyminum), 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 Cuminum cyminum--5 parts by weight Mentha longiflora--4 parts by weight Formulation No. 1

A formulation was prepared with the following ingredients:

TABLE-US-00001 % (wt.) Ingredient Amount (g) 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 Vitamin C (ascorbic acid) - granular 0.007370 0.491560 Niacin Fine USP FCC (nicotinic acid) 0.004061 0.270858 Calcium D-pantothenate USP (vitamin B.sub.5) 0.002188 0.145934 Para-amino-benzoic acid 0.001000 0.066697 Vegetable oil phytosterols 0.001000 0.066697 Vitamin B.sub.6 - Pyridoxine HCl 0.000488 0.032548 Vitamin B.sub.2- Riboflavin USP 0.000347 0.023144 Vitamin B.sub.1- Thiamine HCl 0.000306 0.020409 Vitamin B.sub.12- Cyanocobalamin 1% on 0.000120 0.008004 dicalcium phosphate Excipients Remainder

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.

Formulation No. 2

A formulation was prepared with the following ingredients:

TABLE-US-00002 % (wt.) Ingredient Amount (g) 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 L-carnitine L-tartrate 0.001000 0.055671 Excipients Remainder

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.

Formulation No. 3

A formulation was prepared with the following ingredients:

TABLE-US-00003 % (wt.) Ingredient Amount (g) 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 Mentha 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 HCl 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

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.

Formulation No. 4

A formulation was prepared with the following ingredients:

TABLE-US-00004 % (wt.) Ingredient Amount (g) 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 B.sub.5) 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 units/mg 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 B.sub.6 - Pyridoxine HCl 0.000488 0.009737 Vitamin B.sub.2- Riboflavin USP 0.000347 0.006924 Vitamin B.sub.1- Thiamine HCl 0.000306 0.006106 Vitamin B.sub.12- Cyanocobalamin 1% on 0.000120 0.002394 dicalcium phosphate Excipients Remainder

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.

Formulation No. 5

A formulation was prepared with the following ingredients:

TABLE-US-00005 % (wt.) Ingredient Amount (g) 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 Mentha longiflora) - 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 B.sub.1 - Thiamine HCl 0.001300 0.063107 Vitamin B.sub.2- Riboflavin USP 0.001600 0.077670 Calcium D-pantothenate USP (vitamin B.sub.5) 0.007000 0.339806 Vitamin B.sub.6 - Pyridoxine HCl 0.001800 0.087379 Folic acid - 10% trituration 0.000110 0.005340 Vitamin B.sub.12- Cyanocobalamin 1% on 0.000002 0.000090 dicalcium phosphate Excipients Remainder

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.

Formulation No. 6

A formulation was prepared with the following ingredients:

TABLE-US-00006 % (wt.) Ingredient Amount (g) of total Lady's mantle extract (as Alchemilla 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) (Malpighia 0.000100 0.040074 glabra) - 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) - 0.000100 0.040074 fruit Excipients Remainder

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.

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:

TABLE-US-00007 Start End Weight Subject Gender Wgt. Wgt. Duration 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 5 Female 124.4 110 8 wks., 5 days 14.4 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 10 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.sup. 17.6 13 Female 140.6 123.2 8 wks., 5 days 17.4 Average 166.4 147.8 18.6 Overall Average 143.6 124.5 19.0 Female Average 203.0 185.2 17.8 Male

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).

TABLE-US-00008 Formulation No. 6 Said 2010 Overall Average 11.2% 6.9% Female Average 13.2% 7.5% Male Average 8.8% 6.0%

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.

Formulation No. 7

A formulation was prepared with the following ingredients:

TABLE-US-00009 % (wt.) Ingredient Amount (g) 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

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.

Formulation No. 8

A formulation was prepared with the following ingredients:

TABLE-US-00010 % (wt.) Ingredient Amount (g) of total Lady's mantle extract (as Alchemilla vulgaris) - 0.303000 11.480839 leaf Olive extract (as Olea europaea) - leaf Cumin extract (as Cuminum cyminum) - seed Horsemint extract (as Mentha longiflora) - 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 B.sub.5) 0.002188 0.082905 Para-amino-benzoic acid 0.001000 0.037891 Vegetable oil phytosterols 0.001000 0.037891 Vitamin B.sub.6 - Pyridoxine HCl 0.000488 0.018491 Vitamin B.sub.2- Riboflavin USP 0.000347 0.013148 Vitamin B.sub.1- Thiamine HCl 0.000306 0.011595 Vitamin B.sub.12- Cyanocobalamin 1% on 0.000120 0.004547 dicalcium phosphate Excipients Remainder

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.

Formulation No. 9

A formulation was prepared with the following ingredients:

TABLE-US-00011 % (wt.) Ingredient Amount (g) 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 Horsemint extract (as Mentha longiflora) - leaf Vitamin C (ascorbic acid) - granular 0.003500 0.193469 Excipients Remainder

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

SUMMARY

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 Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora and additional ingredients to enhance weight loss.

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.