AU2012100423A4 - Galactagogue Formulation for Female Mammals - Google Patents

Abstract

The present invention relates generally to a galactagogue formulation for female mammals. Particularly, although not exclusively, the present invention relates to a formulation comprising natural ingredients to protect and promote the health of prenatal and postnatal female mammals.

Description

GALACTAGOGUE FORMULATION FOR FEMALE MAMMALS STATEMENT OF CORRESPONDING APPLICATIONS The present invention is based on the provisional application filed in relation to New Zealand patent application no. 592251, the entire contents of which are incorporated herein. TECHNICAL FIELD The present invention relates generally to a galactagogue formulation for female mammals. Particularly, although not exclusively, the present invention relates to a formulation comprising natural ingredients to protect and promote the health of prenatal and postnatal female mammals. BACKGROUND ART In mammals (including humans) the development of a fetus, and after birth, a baby is directly related to the quantity of the required nutrients it receives, If the child does not receive the required quantity of nutrients (such as vitamins or omega-3-fatty acids) then normal development can be affected. After birth nutrients are received from the mother in breast milk or can be supplied as a supplement. Galactagogues, or substances used to increase milk production in pregnant or nursing females, can be synthetic, naturally derived or endogenous (such as the hormone prolactin). An increase in milk production can be achieved by an increase the quantity of breast milk expressed in the breast tissue per unit time, an increase the time period over which breast milk is produced to prolong the nursing period and/or an increase in the nursing time of the child on the breast.

Synthetic galactagogue substances, usually used in humans, include Metaclopromide, Sulpiride (Egonyl) and chlorpromazine (Thorazine) and Domperidone. These synthetic galactagogues function as dopamine receptor agonists to increase production of prolactin in the body and promote milk production in the milk producing alveolar cells in the breast. Although these medicines produce an improved yield of milk over known plant derived galactagogues they are relatively expensive and can produce side effects. For example, Metaclopromide over consumption can lead to fatigue, diarrhea, restlessness and drowsiness. Domiperidone over consumption may lead to gastrointestinal hemorrhage. It is known in the livestock industry to supplement the normal feed of pregnant or nursing animals with a galactagogue feed additive, usually in the form of a specific herb or seed. Alternatively, the teats of the nursing mother are coated to improve the taste to the infant animals and prolong the time period of suckling. However, the efficacy of any natural galactagogue has yet to be demonstrated in controlled studies. It is an object of the present invention to address the foregoing problems or at least to provide the public with a useful choice. All references, including any patents or patent applications cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicants reserve the right to challenge the accuracy and pertinence of the cited documents. It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not constitute an admission that any of these documents form part of the common general knowledge in the art, in New Zealand or in any other country. 2 It is acknowledged that the term 'comprise' may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, the term 'comprise' shall have an inclusive meaning - i.e. that it will be taken to mean an inclusion of not only the listed components it directly references, but also other non-specified components or elements. This rationale will also be used when the term 'comprised' or 'comprising' is used in relation to one or more steps in a method or process. Further aspects and advantages of the present invention will become apparent from the ensuing description which is given by way of example only. DISCLOSURE OF INVENTION According to one aspect of the present invention there is provided a galactagogue formulation for female mammals, comprising: * milk in the range 1 % to 70%; * at least one gastrointestinal tract native bacterium in the range 0.001 % to 20%; * Yeast extract in the range 1 % to 20%; * a mixture of medicinal plants in the range of 5 % to 20 %; and * sugar in the range of 20 % to 40 %. For the purposes of the specification the term "galactagogue" means a substance that promotes lactation in humans and other mammals. 3 Preferably, the at least one at least one gastrointestinal tract native bacterium is selected from the group consisting of: Lactobacillus acidophilus and Bifidobacterium lactis. Preferably, the mixture of medicinal plants is one or more ingredients selected from the following group: Foeniculum vulgare (fennel); Trigonela foenum-graecum (fenugreek). Preferably, the sugar is one or more ingredients selected from the following group: blackstrap molasses; honey; fructose; corn syrup. Preferably, the galactagogue formulation is administered to a female mammal for oral consumption. More preferably, the galactagogue formulation is suitable for oral consumption in the form of a liquid, tablet, biscuit, powder, granules, syrups or capsule. Preferably, the galactagogue formulation also comprises at least one flavoring. More preferably, the at least one flavoring is selected from the group consisting of: vanilla beans, vanilla extract. Preferably, the galactagogue formulation for female mammals also comprises a mixture of seed powder consisting of cereals; legumes and/or pseudocereals. More preferably, the mixture of seed powder consists of oatmeal and wheat germ. More preferably, the mixture of seed powder is in the range 40 % to 70 %. According to yet another aspect of the present invention there is provided the use of: * milk in the range 1 % to 70%; 4 * at [east one gastrointestinal tract native bacterium in the range 0.001 % to 20%; * Yeast extract in the range 1 % to 20%; * a mixture of medicinal plants in the range of 5 % to 20 %; and * sugar in the range of 20 % to 40 % in the manufacture of a medicament for the treatment of abnormally reduced milk production. According to yet another aspect of the present invention there is provided the use of: * milk in the range 1 % to 70%; * at least one gastrointestinal tract native bacterium in the range 0.001 % to 20%; * Yeast extract in the range 1 % to 20%; * a mixture of medicinal plants in the range of 5 % to 20 %; and * sugar in the range of 20 % to 40 % as a galactagogue formulation to increase milk production in non-human mammals. BRIEF DESCRIPTION OF THE FIGURES The invention will now be described by way of example only and with reference to the accompanying drawings in which: Figure 1 shows a pie-chart representing the change in volume of breast milk as 5 an indication of effectiveness in a trial of the galactagogue formulation shown in Figure 1 on human subjects; Figure 2 shows a pie-chart representing the evaluation of taste of the formulation shown in Figure 1; Figure 3 shows a pie-chart representing the evaluation of ease of consumption of the formulation shown in Figure 1; and Figure 4 shows a pie-chart representing the preferred method of consumption of the galactagogue formulation shown in Figure 1 in a trial of human subjects. BEST MODES FOR CARRYING OUT THE INVENTION The galactagogue formulation of the present invention is used as a nutraceutical to prevent malnutrition associated diseases and aid in the treatment of such diseases by increasing nutrient uptake in a fetus or baby. The combination of ingredients is a mixture having synergistically enhanced properties useful as a food supplement with health protective, preventive and promotive benefits for pregnant and lactating females including pre and post natal stages. In a preferred form of the invention, the ingredients and respective percentages of a galactagogue formulation for female mammals is shown in below in table below. 6 Serve Size (g) No. ServesDay 30,D 2 % Inclusion Amt Per Serve (g) Amt Per Day (g) min Max Min | Max Min Max Instant Whole Mil Powder 104314 65.065 57.445 19.520 17.2335 39.039 34467 Brown Sugar (low moisture) 11.500 11.500 3A50 3.450 6.900 500 Honey Powder 2.370 2.370 0.711 0.711 1.422 1-422 Vania Bean Pod Powder- NEEDS REPLACING. 0.044 . 40.0414 3D11 D.013 0.026 0.026 Dried Yeast G20 "A" (Contains 15O0ppm Gten) 3.340 3.340 1.002 1.002 2.004 2.004 Blackstrap Molasses Powder 3.340 3.340 1.002 1002 2.004 2.004 Fenugreek 3.340 5.900 1.002 1.770 2.004 3.540 Fennel 3.340 8.40a 1,002 2.520 2.004 5.040 Xardhan Gum Gdndsted 200 (A47800)- DOSAGE UNDER REWEW 1.600 1.600 0 420 0AO8 0.960 ;0960 Carrageenan 0200 0.200 0,060 0.060 0.120 D.120 Lactobacilius acidophills NCFM 0.001 0.001 0.0003 0.0003 0.001 0.001 LACTEN Vitamin Px 0.220 0.220 0.066 0.066 0.132 0.12 LACTEN Mineral Px .140 0.140 0.042 0.042 0.084 0.084 Magnesium Sulfate 1.500 1.500 0.450 0.450 0.900 0.900 Vanila Flavour- UNDER REVIEW 2.000 2000 0 600 0.600 1.200 200 Cream Buds Asia - UNDER REVIEW 2.00 2.000 0 600 0;600- 1.200 1.200 100.000 100.000 30.000 30.000 I 60.0 60.000 The galactagogue formulation comprises a dairy base, in the form of instant whole milk powder (at a 57.445 to 65.065 % inclusion) and cream buds (2%). Sugar is provided to improve taste to a suckling child in the form of brown sugar (11.5%), honey powder (2.37%) and blackstrap molasses (3.34%). A mixture of medicinal plants is provided with galactagogue properties in the form of fennel (3.34% to 5.9%) and fenugreek (3.34% to 8.4%). Fenugreek can also favourably modify the taste of milk produced by women to stimulate suckling. In this way the intake of nutrients is promoted by stimulating the child to feed. The inventors have found that the combination of these medicinal plants have a syngergistic effect on breast milk production in female subjects. Carrageenan (derived from red seaweed) is used as a thickening and stabilising agent and to aid in the retention of moisture when the powder is hydrated prior to consumption. An addition thickening agent in the form of xanthan gum (1.6%) is also used. In addition, vitamins (LactenTm vitamin 0.22% and dried yeast (3.34%) and minerals (Lacten T M mineral 0.14% and magnesium sulphate 1.5%) are used in the formulation at levels recommended for lactating women. Magnesium sulphate is also used to 7 delay premature labour and treat eclamptic seizures in pregnant females. Vanilla flavour is provided to promote breast feeding by the child. In addition the dried yeast is used to improve favour to the child as well as a source of vitamins (such as B-complex vitamins). A person skilled in the art will appreciate the galactagogue formulation of the present invention (forthwith called by the proposed product name "LactenTM") can be varied in terms of form, proportions and composition make-up without departing from the scope of the present invention. For example, the formulation can be in liquid form ready to consume and the dairy base take the form of a whole milk, semi-skimmed or skimmed milk in liquid form or as a concentrate. Other flavourings', stabilising agents, minerals and vitamins can be used. For example, at least one omega-3 fatty acid such as docosahexaenoic acid (DHA) can be used to provide their associated health benefits such as improved attention and visual acuity. Each serving of the powder of the present invention is 30g in weight. Water is added to the preferred volume before used and dissolved by mixing and heating as per known milk based formulations. The daily intake can be achieved through two servings per day (60g total weight). LactenTM is manufactured using techniques known to a person skilled in the art such as mixing, freeze drying and packaging. Example: Trial Results The formulation shown in Figure 1 was trialled on a group of 20 women in Auckland, New Zealand. The women were given a questionnaire which asked questions about their current perceptions on the quality of their breast feeding. For a two week period 8 the women were asked to consume the recommended amount of LactenTM formula, during this time they were asked to keep a breast feeding diary throughout the two week period. Following the two week trial of LactenTM they were given a post questionnaire which was used to determine if any of their perceptions around their breast feeding had changed and also asked them for feedback on the LactenTM product. The results were analysed using a Wilcoxon signed rank test to determine any statistical significance in the results within the participants before and after consuming the LactenTM formula for a two week period. Because the women self-selected to participate in this study the sample is non-random and therefore the statistical analyses of the results are indicative only. Response Rate A total of 20 participants were involved in this study. One participant was removed during the early stages of the study as they became ill and began to take medications for an unrelated issue. Two other participants were unable to be contacted following the completion of the trial, therefore their post questionnaires were unable to be included in the analyses. Demographics The ethnicity of the sample was dominated by New Zealand Europeans 66.7% with responses from other ethnic groups being too small to use for analysis. The 25-35 age group was the largest in the sample with 9 participants in this age group. A series of chi-squared tests were used to examine whether the respondents attitudes were related to any of the demographic variables but no statistically significant relationships were found (p>.05 in each case). 9 Effectiveness: Changes in breast milk volume Referring to Figure 1, 44% of Participants rated an "Excellent" change in their volume of Breast milk, 25% a "poor change, 6% for a "good" and "fair" change and 19% as a "very good" change. This graph shows that the majority of participants did witness the positive effects of LactenTM increasing their volume of milk. Taste Referring to Figure 2, this graph shows that there is considerable room to improve the taste of LactenTM with 35% of participants only rating it as "Fair and 12% rating it as "poor". On the other hand 47% of participants rated the taste as "Good" and 6% as "Excellent". Ease of consumption Referring to Figure 3, 25% of the participants found it very easy to consume the recommended amount of Lacten

TM

, 25 % found it was easy to consume and 50% found it was fair to consume. This may have implications for the long term use of LactenTM by some participants. Preferred method of consumption Referring to Figure 4, 53% of Participants would prefer to consume LactenTM in powder form, 29% in a tablet or pill form and 18% as a biscuit. No participants chose a Ready to Drink (RTD) form. Participants would prefer to consume LactenTM in its current powder state over a tablet, biscuit or RTD form. The present invention offers notable advantages over the prior art including: Increased milk production; 10 * Facilitation of longer duration of infant nursing with the resulting increase in infant weight; * Pleasant to drink; and * Minimising the side effects of prescription medicines. Aspects of the present invention have been described by way of example only and it should be appreciated that modifications and additions may be made thereto without departing from the scope thereof as defined in the appended claims. 11

Claims (5)

1. A galactagogue formulation for female mammals, comprising: * milk in the range 1 % to 70%; * at least one gastrointestinal tract native bacterium in the range 0.001 % to 20%; * Yeast extract in the range 1 % to 20%; * a mixture of medicinal plants in the range of 5 % to 20 %; and * sugar in the range of 20 % to 40 %.

2. A galactagogue formulation for female mammals as claimed in claim 1 wherein the at least one gastrointestinal tract native bacterium is selected from the group consisting of: Lactobacillus acidophilus and Bifidobacterium lactis.

3. A galactagogue formulation for female mammals as claimed in claim 1 or claim 2 wherein the mixture of medicinal plants is one or more ingredients selected from the following group: Foeniculum vulgare (fennel); Trigonella foenum-graecum

4. The use of: * milk in the range 1 % to 70%; * at least one gastrointestinal tract native bacterium in the range 0.001 % to 20%; * Yeast extract in the range 1 % to 20%; 12 * a mixture of medicinal plants in the range of 5 % to 20 %; and * sugar in the range of 20 % to 40 % in the manufacture of a medicament for the treatment of abnormally reduced milk production.

5. The use of: & milk in the range I % to 70%; 9 at least one gastrointestinal tract native bacterium in the range 0.001 % to 20%; * Yeast extract in the range 1 % to 20%; * a mixture of medicinal plants in the range of 5 % to 20 %; and * sugar in the range of 20 % to 40 % as a galactagogue formulation to increase milk production in non-human mammals. 13