NUTRITIONAL SUPPLEMENT COMPRISING MICROALGAE, VITAMINS AND MINERALS

Abstract

Multivitamins and multi-mineral supplements are widely used as a remedy for lack of proper nutrition. However, they tend to be scarcely assimilated, and more and more scientific reports claim that they are relatively useless if not harmful. This invention is an answer to this problem, as it provides a novel product, based on the nutritional bounty of cyanobacterial blue-green algae, and reinforced by foods and herbal extracts rich in one or more of the vitamins or minerals missing or scarce in the cyanobacterial blue-green algae. The result is a multivitamin and multi-mineral supplement that is completely organic and, being from alimentary and herbal sources that are recognized as foods by our organism, are much better assimilated. This invention provides an optimal solution to the conundrum we face today: the standard contemporary diet does not provide enough nutrition, with negative consequences on our health; but the inorganic and synthetic supplements we consume are not really foods, and so are ineffective. The product we have invented is an effective and innovative answer to this problem.

Claims

1. A composition which always includes a nutritionally dense micro algae, such as but not limited to Aphanizomenon flos aquae, further supplemented by specific food and plant extracts rich in the natural, food derived vitamins and/or minerals that are lacking, or are insufficiently present in the same micro algae, in order to provide a multi-nutrients supplement as complete and as food based as possible.

2. A nutritional supplement according to claim 1 in which the micro algae is the Aphanizomenon flos aquae cyanobacterial micro algae from Klamath Lake, Oregon.

3. A nutritional supplement according to claim 1 whereby the micro algae selected is any other micro algae, cyanobacterial or not, which is fit for human consumption and nutritionally dense.

4. A nutritional supplement according to claim 1 , whereby the further source of natural, food derived Vitamin A (betacarotene) is an extract of Dunaliella Salina, Annatto seeds, sweet potato, carrots, kale, or any other food-source of Vitamin A/Betacarotene.

5. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Vitamins B is an extract from Klamath AFA microalgae, leafy green vegetables, beans (green pea, lentils), fruit extracts (such as Guava, Mango, Lemon), Holy Basil or any other food rich in B vitamins.

6. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Vitamin C is selected among extracts from fruits such as Acerola, Rosa Canina, Amla, and any other food rich in natural Vitamin C.

7. A nutritional supplement according to claim 1, whereby the source of natural, food derived Vitamin D is an extract of mushrooms, or any other food source of Vitamin D.

8. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Vitamin E is an extract of soybeans, sunflower seeds, Annatto fruit (Bixa Oreliana), or any other dried oil and food representing a good source of vitamin E.

9. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Chromium is an extract of grape juice, chromium-rich yeast, broccoli and/or Moringa Oleifera, sweet potato, apples, or any other natural food source of chromium.

10. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Iron is an extract of beans, clams, blackstrap molasses, stinging nettle, pumpkin seeds, curry (Muraya koeinigii) leaves, or any other food rich in iron.

11. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Selenium is an extract of mustard seeds, Brazilian nuts, Brassica Nigra, or any other foods rich in Selenium.

12. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Zinc is an extract of oysters and seashells, or wheatgerm, or nuts and seeds, or Guava leaves.

13. A nutritional supplement according to claim 1, which is provided in different pharmaceutical forms, such as sachets, tablets, capsules or liquids.

14. A nutritional supplement according to claim 1 for human or animal consumption.

15. A nutritional supplement according to claim 1, whereby the further source of natural, food derived Iodine is an extract of the macro algae Kelp, or any other algae or food rich in iodine.

16. A nutritional supplement according to claim 1 whereby the micro algae is Spirulina.

17. A nutritional supplement according to claim 1 whereby the micro algae is Chlorella.

18. A nutritional supplement according to claim 1, whereby the micro algae used is a blend of the different microalgae.

19. A nutritional supplement according to claim 1, used to prevent or treat the nutritional deficiencies dependent on the lack of one or more of the nutrients provided by the supplement.

20. A nutritional supplement according to claim 1, where the supplement is used to prevent or treat the human or animal pathologies associated with said nutritional deficiencies.

Description

DISCLOSURE OF THE INVENTION

[0016] The natural organic multi-vitamins and multi-minerals supplements will be manufactured in two or more possible formats: [0017] a) a bottled supplement of 30, 60, 90 or more capsules or tablets, with the capsules being of the 0 or 00 type; and the tablets being of 500 mg. to 1 gram; [0018] b) a supplement formed by sachets, each having the whole or half of the daily dosage of the supplement; [0019] c) a liquid drink containing dissolved powder providing enough of the combination of food source nutrients to be RDA-relevant.

[0020] Let's thus look at each nutrient, to see how the combination of microalgae, especially AFA, with one or the other high concentrated source of the same nutrient can help our novel nutritional supplement to reach an RDA-relevant status for most nutrients.

[0021] The reason why AFA can constitute the fundamental base of an organic, food grade nutritional supplement is due to the fact that altogether it is the food that has the widest spectrum of RDA-relevant nutrients, so that it becomes possible to add few other food or herbal extracts to the basic 2 grams of algae (more or less) to obtain a product capable of providing a wide spectrum of RDA-relevant nutrients in their natural and thus assimilated food form.

[0022] Vitamins

[0023] Vitamin A

[0024] AFA algae at its best, contains approximately 200 mcg. of vitamin Agram, so 2 grams of AFA a day would provide about 400 mcg. or approximately 50% of the RDA/LARN. In reality, vitamin A as such is contained only in animal and dairy foods, while vegetable sources contain carotenes that act as vitamin A precursors. AFA algae and Spirulina are such sources of carotenes, as is the microalgae Dunaliella salina. There are other good food and herbal sources of food grade vitamin A that could be used, such as Annatto (Bixa orellana) seeds, but few pack such high amounts of vitamine A precursors such as the microalgae. So, our best choice would be an extract from the microalga Dunaliella salina, with a 7.5% betacarotene concentration. The numbers given below are thus obtained: 100 mg. of Dunaliella extract contains 7.5 mg. of betacarotene; to convert betacarotene into vitamin A we divide such quantity by 6, thus obtaining 1.250 mg. of vitamin A. The same rate of conversion is applied to the AFA algae's carotenes.

TABLE-US-00003 Dunaliella extract AFA algae Vitamin 100 mg. 2 grams Total % RDA Vitamin A as 750 mcg. 400 mcg. 1,150 mg. 127% betacarotene

[0025] B Vitamins

[0026] Again, AFA algae provides in 2 grams substantial quantities of the main B vitamins, and more specifically (RDAs are calculated on the EU standards):

TABLE-US-00004 B1 - 500 mcg. 45.5% RDA B2 - 75 mcg. 5.3% RDA B3 - 7 mg. 38.8% RDA B5 - 3 mg. 43% RDA B6 - 54 mcg. 3.8% RDA B9 - Folic acid 80 mcg. 40% RDA B12 - Cobalamine 2.5 mcg..sup.1 100% RDA .sup.1The actual content of B12 in AFA is between 6 to 8 mcg. x gram. However, a substantial percentage of AFA's B12 is formed by cobalamine analogues, only about 20% of it being true cobalamine, we calculated that the actual B12 is about 2.5 mcg. in 2 grams of algae. For its absorption, see: Baroni L. et al, 2009.

[0027] We see that AFA algae is probably the best source of organic, food grade B vitamins overall. However, apart from B12 at 100%, the other B vitamins are some RDA-relevant (that is they provide a minimum of 15% of the RDA), some others, such as B2 and B6, are non RDA-relevant. How to supplement those specific vitamins from other food sources? Particularly good sources of B-vitamins are avocado, pomegranate, dates, watermelon, and some berries; leafy greens and vegetables such as amaranth, Swiss chard, kale, Brussels sprouts, potatoes, squashes and parsnips also contain significant amounts; among legumes soy beans, black-eye peas and edamame contain high amounts of B9, also known as folate. A possible alternative would be to extract the B-vitamin complex from the very cyanobacterial micro algae such as Klamath algae and/or Spirulina, or from fruits such as Lemon, Guava and Mango, or herbs such as Holy Basil. Thus, a blend of extracts from these foods can produce a high concentrated spectrum of B-vitamins. Just as an example, we have performed a water extraction from a blend of different foods, namely Klamath microalga, Lemon, and Mango, and by adding just 180 mg. of such an extract blend to the basic 2 grams of AFA in the daily dosage we obtain the following values:

TABLE-US-00005 AFA & Fruits B Vitamins extract Whole AFA Daily dose % NRV B1 -Thiamine 3.6 mg 0.5 mg 4.1 mg 372% B2 - Riboflavin 3.78 mg 0.075 mg 3.855 mg 275% B3 - Niacin 6.12 mg 7 mg 13.12 mg 82% B5 - Pantothenic 6.84 mg 3 mg. 9.84 mg. 164% Acid B6 - Pyridoxine 4.32 mg. 0.054 mg. 4.374 mg 312% B9 - Folic Acid 126 mcg. 80 mcg. 206 mcg. 103% B12 - Cobalamine 1 mcg. 2.5 mcg. 3.5 mcg. 140%

[0028] As evident from the above table, the daily dose of the AFA based organic nutritional supplement provides all the B-Vitamins in an RDA-relevant quantity. Indeed, with the sole exception of Niacin, at 73% of the RDA, all the other vitamins are given in quantities well above 100% of the minimum daily requirement, leaving thus open the possibility if using lower quantities of the extract, thus also reducing the cost of the product.

[0029] Vitamin C

[0030] AFA algae is a source of vitamin C, as opposed to other microalgae such as Spirulina. However, its content is limited, and in 2 grams it only provides about 4 mg., vs. an NRV of 80 mg. The sources of natural, organic, food grade vitamin C are many, starting with the Rosa Canina fruit, or the Acerola fruit, or the indian fruit Amla, as well as lemon or other citrus fruit extracts. Any one of such food extracts can be a good integration for the little vitamin C provided by AFA. In the following table an example with the Acerola extract at 34% vitamin C:

TABLE-US-00006 Acerola extract 34%, AFA algae Vitamin 225 mg. 2 grams Total % NRV Vitamin C 76.5 mg. 4 mg. 80.5 mg. 100%

[0031] Vitamin E

[0032] Vitamin E is the other vitamin of which AFA is a source, but a poor one in relative terms. In absolute terms, AFA has actually a very high content of vitamin E: in 100 grams, it contains 25 mg., or 250% of the daily requirement. But in just 2 grams, it provides 0.5 mg., or only 5% of the daily requirement. There are a few powder sources of natural vitamin E, and they are generally dried oil based sources (vitamin E being a fatty vitamin). Among those, extracts from soy seeds, sunflower seeds, or Annatto seeds, are the most common. A sunflower seed extract, for instance, provides 15 mg. of vitamin E in just 100 mg.:

TABLE-US-00007 Sunflower seed AFA algae Vitamin extract 15% - 80 mg. 2 grams Total % NRV Vitamin E 12 mg. 0.5 mg. 12.5 mg. 104%

[0033] Vitamin D

[0034] Vitamin D is found very scarcely in foods, and can be synthesized by our body from sunlight. However, as more and more people are deprived of natural sunlight, providing a food source of vitamin D can be important. AFA algae may have traces of vitamin D, but they are not really relevant. The concentrated food sources of vitamin D are very few. One of these are mushrooms: a mushroom extract can provide up to 5,000 IU of vitamin D2gram (equivalent to 125 mcg.). Thus, 50 mg. of such extract can provide approximately 6,25 mcg., which is equivalent to 250% of the Italian RDA, and to 83% of the American RDA:

TABLE-US-00008 Mushroom extr 5000 AFA algae Vitamin IU/gr - 50 mg. 2 grams Total % NRV Vitamin D 6.25 mcg. 0 mcg. 6.25 mcg. 125%

[0035] Vitamin K

[0036] Vitamin K is an essential vitamin which, in its natural form, plays a variety of physiological functions, such as blood coagulation and bone formation. Leafy green vegetable are a food source of vitamin K, but so is AFA algae, which provides a whooping 60 mcg./gr., and so in 2 grams 160% of the EU Nutritional Reference Value (NRV) and 100% of the US DRI:

TABLE-US-00009 AFA algae Vitamin Other sources 2 grams Total % NRV Vitamin K 0 mcg. 120 mcg. 120 mcg. 171%

[0037] Minerals

[0038] Concerning the ability of the product to provide RDA-relevant quantities of minerals, we need to clarify 3 different aspects:

[0039] Macrominerals

[0040] Macrominerals such as calcium, magnesium, phosphorous, etc. have such high RDAs quantities that it is impossible to provide RDA-relevant quantities in a few grams of a nutritional supplement. This is why macrominerals need to be supplemented thorough a specific product, and cannot but be excluded from the RDA relevant spectrum of nutrients included here.

[0041] Trace Minerals

[0042] There is then the list of all trace minerals, for which no daily requirement has been established but that are often considered quasi-essential (Uthus, 1990; Mayer et al., 1993). We don't really need to do anything about these, as AFA algae is actually the best living source of such trace minerals, having their complete spectrum and thus providing trace quantities of petty much all of them, as visible from the table below (ppmpartsmillions):

TABLE-US-00010 Boron 11.4 Calcium 8100 Barium 5.67 Niobium 0.08 Aluminum 38.2 Chromium 0.92 Beryllium <.01 Osmium <.05 Cobalt 1.28 Copper 7.29 Bismuth 0.29 Palldium <.01 Antimony 2.48 Germanium 0.43 Bromine 47.2 Platinum <.01 Iodine 18.3 Iron 4190 Cadmium 0.107 Prascodymium 0.15 Magnesium 31.9 Manganese 24.7 Carbon 936,000 Rhenium <.05 Molybdenum 3.77 Nickel 6.37 Cerium 1.21 Rhodium <.01 Phosphorus 16.2 Potassium 15,200 Cesium 0.09 Rubidium 0.9 Selenium 0.488 Silicon 233 Chloride 16,200 Ruthenium 0.06 Sodium 19.2 Titanium 0.48 Mercury 0.007 Samarium 0.85 Tin 0.12 Zinc 2.98 Neodymium 0.31 Scandium 0.037 Dysprosium 0.347 Hafnium 0.076 Lutctium 0.089 Thallium 2.85 Erbium 0.882 Holmium 0.054 Silver 0.018 Thorium <.05 Europium <.05 Indium 0.077 Strontium 5.88 Thulium 0.095 Fluoride 872 Iridium <.05 Sulfur 350 Tungsten 0.091 Gadolinium 0.96 Lanthanum <.05 Tantalum 0.65 Vanadium 1.8 Gallium 0.82 Lead 0.082 Tellurium 0.11 Ytterbium 0.084 Gold 0.037 Lithium 0.74 Terbium 0.071 Yttrium 0.192 Zirconium 0.74

[0043] Microminerals with a Daily Requirement

[0044] There are about 11 microminerals for which a NRV/DRI has been established in the order of milligrams or micrograms. Our novel product manages to provide as many as 9 of these minerals in a natural and organic form and at levels equal or above 100% of the daily requirement.

[0045] Chromium

[0046] Chromium, like vanadium, plays an important role in the regulation of sugar metabolism, a role that is very important in today's world, with an increasing growth of what is defined as metabolic syndrome, and that includes pathologies such as diabetes and obesity. AFA algae contains a little amount of chromium, approximately 2 mcg. in 2 grams; and in order to reach the RDA of 35 mcg. we need to introduce some other foods, such as extracts from grape juice, chromium-rich yeast, and most of all broccoli and other Brassicaceae such as the Moringa plant (and extract of which can provide up to 33 mcg. in just 33 mg. of extract).

TABLE-US-00011 Moringa Oleifera AFA algae Mineral extract - 38 mg. 2 grams Total % NRV Chromium 38 mcg. 2 mcg. 40 mcg. 100%

[0047] Iron

[0048] As visible in the table above, AFA algae contains approx. 4 mg/gr. of iron, a very substantial quantity. That in itself represents 50% of the US DRI; and approximately 30% of the EU's NRV. Thus, 2 grams of AFA algae in the formula can provide up to 100% of the US DRI and almost 60% of the EU's NRV. As this quantity may not always be guaranteed, since there may be variations in the iron content of the algae; and as we may need to increase the quantity to reach 100% of the European daily requirement, we can use other sources of organic iron, such as extracts of clams, of certain types of beans, backstrap molasses, or curry plant leaves (Muraya koeinigii). For instance, by adding 200 mg. of a curry plant leaves's extract, we can obtain the following:

TABLE-US-00012 Muraya koeinigii AFA algae Mineral leaves extr. 200 mg. 2 grams Total % RDA Iron 7.2 mg. 8 mg. 15.2 mcg. 108%

[0049] Fluoride

[0050] As opposed to the industrially produced sodium fluoride, the calcium fluoride found in nature and in natural foods is essential for bone and teeth formation and maintenance. AFA algae has very high content of natural fluoride, about 1 mg/gr., approximately 57% of the new and heightened NRV, a quantity that is in itself significantly relevant to the satisfaction of the daily requirement.

TABLE-US-00013 AFA algae Mineral Other sources 2 grams Total % RDA Fluoride 0 mg. 2 mg. 1.74 mcg. 57%

[0051] Iodine

[0052] Iodine is an essential mineral for metabolism and thyroid function. However, excess iodine may be problematic for people with hyperactive thyroid, and while it is important for a multi-nutrients supplement to provide some iodine, it may be better not to provide too much. AFA algae has a useful content of iodine, which taken daily may be enough in itself, even though it can be eventually supplemented with a specific kelp extract.

TABLE-US-00014 AFA algae Mineral Kelp extract 30 mg. 2 grams Total % RDA Iodine 25 mcg. 36 mcg. 61 mcg. 40%

[0053] Molybdenum

[0054] Molybdenum is a trace mineral essential for the activation of many enzymes and for a proper protein metabolism, being crucial to the synthesis of amino acids. Its presence in the diet depends on its presence in the soil, and so its content in specific foods is variable. Good sources are beans and lentils, as well as nuts and dairy, 2 grams of AFA algae provide approximately 16% of the RDA, a quantity sufficient to qualify the product as a good source of molybdenum.

TABLE-US-00015 AFA algae Mineral Other sources 2 grams Total % RDA Molybdenum 0 mg. 8 mcg. 8 mcg. 16%

[0055] Selenium

[0056] Selenium is one of the few trace minerals for which there is an official daily requirement. This is due to the fact that many studies have been performed showing the very relevant anti-oxidant properties of this mineral, especially again in its natural and organic form. AFA algae is a source of selenium, but in small quantity, only about 0.5 mcg./gr. We thus need to supplement this quantity with an alternative good natural source. Among the various good vegetable sources, the best ones are Brazilian nuts and Mustard seeds (Brassica nigra). An extract of either one can provide about 0.5%/dw of selenium, thus providing 100% of the RDA in just 11 mg.

TABLE-US-00016 Brassica nigra seeds - AFA algae Mineral 12 mg. 2 grams Total % NRV Selenium 60 mcg. 2 mcg. 62 mcg. 112%

[0057] Vanadium

[0058] Vanadium is an essential mineral in relation to the sugar metabolism. It acts in fact as an insulin-mimetic mineral, able to stimulate the insulin receptor, thus reducing the quantity of insulin needed. AFA algae is a good source of vanadium, and thus may not need to be supplemented by any other source; even though it could be enriched by adding extracts from buckwheat or parsley. However, while there was a daily requirement for vanadium in Italy (10 mcg.), lately the EU aligned with the US, where there is no such requirement, so right now vanadium is no longer a trace element endowed with an RDA. We report it anyway, because vanadium has known properties, and because it could be reinserted in the official daily requirements list.

TABLE-US-00017 AFA algae Mineral Other sources 2 grams Total % RDA Vanadium 0 mg. 6 mcg. 6 mcg. 60%

[0059] Zinc

[0060] Zinc is an important trace mineral, insofar as it regulates normal biochemical functions in the body, such as supporting a healthy immune system, and acting as an enzyme activator in the many chemical reactions of our cells, our brain and the normal human development. Zinc is also important for the male reproductive system, and thus also to reduce the risk of prostate cancer. AFA algae contains a little quantity of zinc, at least in the relative terms of the 2-3 grams used as a supplement, approximately 80 mcg. for 2 grams. Thus, to produce a nutritional supplement as complete as possible based on AFA algae, we need to find a further source of zinc. Good candidates are extracts from oysters and other seashells (though quite expensive) , wheatgerm, nuts and seeds, and even an extract from micro algae such as AFA, or from Guava (Psidum Gujava) leaves, which can provide the RDA of 11 mg./day in just 250-300 mg.

TABLE-US-00018 AFA algae Mineral Guava leaves ext 250 mg. 2 grams Total % RDA Zinc 10 mg. 80 mcg. 10.08 mg. 100%

[0061] The Final Product

[0062] To conclude, the product that we have described uses AFA algae (or eventually Spirulina or Chlorella algae, though less nutrient-dense substitutes) as a base to be supplemented by other organic, natural extracts, each one rich in a certain vitamin or mineral in their organic and thus absorbable form. This product provides the full daily intake requirements, most of which at or above 100%, for all the vitamins and the most important micro and trace minerals, again in a form that is natural, organic, derived from food sources, and thus fully recognized by our body as food and consequently properly absorbed and utilized.

[0063] A possible version of this product, which is given here as an example and that does not exhaust the list of possible other versions (including different sources and concentrations), is the following, based on a sachet containing the following quantities of actives:

TABLE-US-00019 AFA Klamath algae 2,000 mg. Extract of AFA algae and fruits 180 mg. (mango, lemon) - B vitamins Sunflower ext. - 15% Vit. E 80 mg. Moringa Oleifera extr. (0.1% Chromium) 38 mg. Curry leaves extract - Iron 200 mg. Dunaliella extr. - Betacarotene/vit. A 100 mg. Brassica Nigra seeds extr. - Selenium 12 mg. Guava leaves ext. - Zinc 250 mg. Acerola extr. - Vit. C 120 mg. Kelp extract - Iodine 30 mg. Mushrooms extr. - Vit D 50 mg. 3,060 mg.

BIBLIOGRAPHY

[0064] Baroni L., Scoglio S. et al., Effect of a Klamath algae product (AFA-B12) on blood levels of vitamin B12 and homocysteine in vegan subjects: a pilot study, Int. J. Vitam. Nutr. Res., 79 (2), 2009, 117-123.

[0065] Heart Protection Study Collaborative Group (Oxford University), MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20 536 high-risk individuals: a randomised placebo-controlled trial, in Lancet 2002; 360: 7-22.

[0066] Mayer D R et al., Essential trace elements in humans. Serum arsenic concentrations in hemodialysis patients in comparison to healthy controls, in Biol Trace Elem Res. 1993 April; 37(1):27-38.

[0067] Miller E. R. III et al, Meta-Analysis: High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality, in Annals of Internal Medicine, 2005, 142: 37-46.

[0068] Omenn G S, Risk factors for lung cancer and for intervention effects in CARET the Beta-Carotene and Retinol Efficacy Trial, in J Natl Cancer Inst 1996 Nov. 6; 88(21):1550-9.

[0069] Pennington J. A., Young B. E., Total diet study nutritional elements, 1982-1989., J Am Diet Assoc. 1991 February; 91(2):179-83.

[0070] Syrad H. et al., Energy and nutrient intakes of young children in the UK: findings from the Gemini twin cohort. Br J Nutr. 2016 May 28; 115(10):1843-50.

[0071] Uthus E O., Effects of arsenic deprivation in hamsters, in Magnes Trace Elem. 1990; 9(4): 227-32;