Weight loss formulation

Information

  • Patent Grant
  • 9220741
  • Patent Number
    9,220,741
  • Date Filed
    Tuesday, August 30, 2011
    13 years ago
  • Date Issued
    Tuesday, December 29, 2015
    9 years ago
Abstract
A method of enhancing weight loss involves administering to an overweight human a weight loss product that includes a mixture of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora (in the weight proportion 12:10:5:4), to which is added at least one herbal ingredient such as Malpighia glabra. As additional ingredients at least one of Conjugated linoleic acid and caffeine can be provided, with the caffeine in the form of caffeine anhydrous, Coffea Arabica, Coffea canephora, Camellia sinensis, Ilex paraguariensis, Guarana, Theobroma cacao, and kola nut. In one preferred embodiment the method involves administering, optionally in tablet form, a composition consisting essentially of the mixture of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora; caffeine anhydrous; Vitamin C; Lyceum barbarum; Malpighia glabra; Blueberry; Punica granatum; Bilberry; and one or more excipients. Other ingredients may be used as well in accordance with specific disclosed formulations.
Description
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™ 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™ 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™.


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™ 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:
















% (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 B5)
0.002188
0.145934


Para-amino-benzoic acid
0.001000
0.066697


Vegetable oil phytosterols
0.001000
0.066697


Vitamin B6 - Pyridoxine HCl
0.000488
0.032548


Vitamin B2- Riboflavin USP
0.000347
0.023144


Vitamin B1- Thiamine HCl
0.000306
0.020409


Vitamin B12- 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:
















% (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:
















% (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:
















% (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 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 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 B6 - Pyridoxine HCl
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









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:
















% (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 B1 - Thiamine HCl
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 HCl
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









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:
















% (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:



















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
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).















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:
















% (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:
















% (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 B5)
0.002188
0.082905


Para-amino-benzoic acid
0.001000
0.037891


Vegetable oil phytosterols
0.001000
0.037891


Vitamin B6 - Pyridoxine HCl
0.000488
0.018491


Vitamin B2- Riboflavin USP
0.000347
0.013148


Vitamin B1- Thiamine HCl
0.000306
0.011595


Vitamin B12- 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:
















% (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.

Claims
  • 1. A method of enhancing weight loss in an overweight human individual comprising administering to the individual an effective amount of a composition consisting essentially of a mixture of Alchemilla vulgaris, Olea europaea, Cuminum cyminum, and Mentha longiflora; caffeine anhydrous; Vitamin C; Lyceum barbarum; Malpighia glabra; Blueberry; Punica granatum; Bilberry; and one or more excipients.
  • 2. A method of enhancing weight loss as in claim 1, wherein the ingredients of the composition are present in the following respective forms and weight percentages:
  • 3. A method of enhancing weight loss as in claim 2, wherein the mixture ingredients are present in the mixture in the following proportions: Alchemilla vulgaris—12 parts by weight;Olea europaea—10 parts by weight;Cuminum cyminum—5 parts by weight; andMentha longiflora—4 parts by weight.
  • 4. A method of enhancing weight loss as in claim 3, wherein the composition is provided in tablet form, each tablet including the following amounts by weight of the respective ingredients:
  • 5. A method of enhancing weight loss as in claim 4, wherein the method comprises administering two tablets to the individual three times a day.
CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. provisional application No. 61/376,098, filed Aug. 30, 2010, which application is incorporated herein by reference.

US Referenced Citations (1)
Number Name Date Kind
20090214680 Giuliano et al. Aug 2009 A1
Non-Patent Literature Citations (6)
Entry
Visentainer et al., Vitamin C in Barbados cherry Malpighia glabra L. pulp submitted to processing and to different forms of storage, 1998, Arch Latinoam Nutr, 48: 256-9.
EFSA: Scientific Opinion on the Safety of ‘Conjugated Linoleic Acid (CLA)-Rich Oil’ (Tonalin® TG 80) As a Novel Food Ingredient; EFSA Journal 2010; 8(5):1000 pp. 1-43).
Said, O., et al., “A Double Blinded-Randomized Clinical Study with ‘Weighlevel,’ a Combination of Four Medicinal Plants Used in Traditional Greco-Arab and Islamic Medicine,” The Open Complementary Medicine Journal, 2010, 2, pp. 1-6.
Said, O., et al., “Weight Loss in Animals and Humans Treated with ‘Weighlevel’, a Combination of Four Medicinal Plants Used in Traditional Greco-Arab and Islamic Medicine,” eCAM Advance Access published Oct. 24, 2008, pp. 1-7.
Said, O., et al.,“Weight Loss in Animals and Humans Treated with ‘Weighlevel,’ a Combination of Four Medicinal Plants Used in Traditional Greco-Arab and Islamic Medicine,” Evidence Based Complementary and Alternative Medicine, vol. 2011, Article ID 874538, pp. 1-6.
Sprunk-Jansen LLC Press Release on WEIGHLEVEL study, Feb. 2010.
Related Publications (1)
Number Date Country
20120052137 A1 Mar 2012 US
Provisional Applications (1)
Number Date Country
61378098 Aug 2010 US