cvd-pharma.com MENACIN TM The simple solution TO the Calcium Paradox

Transcription

1 cvd-pharma.com MENACIN TM The simple solution TO the Calcium Paradox

2 cvd-pharma.com INDEX The Calcium Paradox / 3 / Is calcium supplementation a cause for concern? / 4 / Menacin TM facts / 5 / Menacin TM and Bone Health / 7 / Menacin TM and Healthy Heart / 11 / Short summary / 12 / Menacin TM is suitable for all ages / 13 / Menacin TM products / 14 / CVD Ingredients; A Reliable Supplier / 15 / References / 16 / About CVD Ingredients / 17 / Contact / 18 / 2

3 The Calcium Paradox Lack of calcium in bones make them porous and brittle. Excess calcium in blood vessel walls impede blood flow. This delicate balance is sometimes referred to as the Calcium Paradox. The solution might be, vitamin K2, 2 a little known vitamin that could save peoples life! The natural form as vitamin K2 is a fat soluble vitamin necessary for the carboxylation of osteocalcin and matrix Gla-protein (MGP), two vitamin K dependent proteins that are needed in an active form for a safe and effective calcium utilization! Fortunately the medical community is now beginning to accept the importance of vitamin K2. VITAMIN K2 Excess in calcium takes part in narrowing blood vessel walls through plaque buildup. Lack of calcium in bones makes them porous and brittle. Menacin TM formulations Menacin TM formulations ensures that calcium is put in the right place (i.e. Bones) where its needed! 3

4 cvd-pharma.com Is calcium supplementation a cause for concern? British Medical Journal (BMJ) 2008 Calcium supplements in healthy post-menopausal women are associated with upward trends in cardiovascular event rates. This potentially detrimental effect should be balanced against the likely benefits of calcium on bone. This 5 year study on postmenopausal women suggests that women who take calcium supplements may have increased risk of heart attack, stroke or sudden death; because calcium supplements may accelerate the formation of calcium deposits in the arteries by increasing blood calcium levels. 1...A statically significant increase was found in the number of women who had a myocardial infarction in the calcium group compared with placebo... The Rotterdam Study Another large epidemiological population-based study published in The Rotterdam Study with 4473 subjects with no history of Myocardial infarction, over a period of 10 years showed a significant 50% reduction in Coronary Heart Disease (CHD), mortality and aortic calcification CHD mortality for those who were in the 45 mcg per day of dietary intake of vitamin K2-7 in the upper tertile and 25% reduction in 24 mcg per mid tertile compared to the 12.5 mcg per day lower tertile. Such dose-response relationship in a population was impressive for the new role of vitamin K2-7. Their findings did not show any correlation between vitamin K1 intakes to the CHD outcome A statically significant reduction of cardiovascular diseases and death by 50 %... The Gast Study The Gast study published in 2009 with participants over 8,1 years confirmed the Rotterdam study and conclude a 9% reduction in risk of developing CHD for every 10 mcg of natural vitamin K2 consumed. The highest average consumption was >36 mcg K2/day. This study could not confirm a protective effect of vitamin K1 for coronary calcification and CHD similar to the conclusions of Rotterdam study. The need for a higher dose of vitamin K2-7 was obvious % reduction of risk of Coronary Heart Disease for every 10 mcg natural K2-7 a day... CVD Ingredients find these studies quite disturbing, and are thus increasingly convinced that our natural vitamin K2-7 containing Menacin TM formulas ensure that calcium is put in the right place (i.e. bones) where it is needed. Menacin TM ensure that calcium is kept out of the soft tissues and arteries where it is harmful as the studies have shown. 1,3 4

5 Menacin TM facts Menacin products always contains natural vitamin K2-7 from natto that has optimal bioavailability, serum half life and bioactivity. Vitamin K2 (MK-7) is 6 times more potent than vitamin K1, and is also the form of vitamin K that has been found to protect against arterial calcification. 2 Due to these properties the vitamin K2-7 dosage needed to have a significant effect is in the microgram and not in the milligram range as other competing vitamin K products. The Menacin product line is currently composed of four carefully selected formulations for a safe and effective calcium utilization. Menacin is produced in a GMP certified facility for CVD Ingredients. Menacin TM formulations: Menacin Green: Vitamin K2-7 Menacin Red: Vitamin K2-7, Calcium Carbonate and Vitamin D3 Menacin Purple: Vitamin K2-7, Calcium Carbonate, Magnesium Oxide, Vitamin D3 and Vitamin A Menacin Blue: Vitamin K2-7 and Omega-3 How does Menacin TM tablets promote cardiovascular health and strengthen bones? Carboxylates matrix Gla-protein (MGP). Activated MGP inhibits vascular calcification. Promotes blood vessel elasticity by safeguarding elastin, the protein responsible for the elasticity of the arterial walls. Increases the production of osteoblasts Increases the production of osteocalcin Ensures that calcium is deposited into the bone and doesn t leak into the bloodstream where it may deposit in the arteries. Inhibits the production of osteoclasts The Osteoporosis process 40 years old 60 years old 70 years old 5

6 cvd-pharma.com All ingredients in the Menacin TM product line are carefully selected and work synergistically, which may assist with: Building and maintaining strong bones Preventing cardiovascular diseases Optimizing the peak bone mass Reduces the risk of cardiovascular death with 50%! 3 Decades of testing and hundreds of published studies prove that vitamin K2 is an essential nutrient, and that it may be the solution to keep calcium in its place! 2 Menacin TM will thus help to keep calcium in bones and improve cardiovascular health. 2 Without sufficient vitamin K2 intake, the population will continue to suffer from cardiovascular diseases and osteoporosis. 6

7 Menacin TM and Bone Health Calcium in relation to bone health Bone is a living tissue and calcium plays a very important role in our bones. Bone is constantly being remodeled throughout adult life. The old bone is removed and replaced by new bone. This is a natural process called remodeling. The process of bone resorption and formation throughout adult life is equal so there is no net change in bone mass. Osteoclasts are specialized cells responsible for bone resorption while osteoblasts are bone building specialized cells that secret osteocalcin which is a vitamin K dependent protein and capable of binding calcium optimally to the bone matrix when carboxylated by Menacin TM ingredient vitamin K2-7. In childhood bone formation exceeds bone resorption. The situation is opposit when humans age and bone resorption outstrips bone formation. This imbalance can cause diseases such as osteoporosis. Several human studies have shown that calcium supplementation on its own isn t enough to prevent osteopenia, osteoporosis or fractures. Why? There are two vitamins and a popular mineral known to be involved with calcium metabolism; vitamin D, vitamin K and magnesium. 4 Calcium has for decades been the most obvious choice of dietary supplement for improving bone health and is needed to build the hydroxyapatite matrix in our bones. Calcium is also required for muscle contraction, blood vessel expansion and contraction, transmitting impulses throughout the nervous system, secretion of hormones and enzymes. The large majority of calcium (99 %) in our bodies is in our bones and some in teeth, only 1 % is found in the circulation. Vitamin D in relation to bone health Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. By adding vitamin D we optimize the bodies use of calcium. Vitamin D is needed for bone growth and bone remodeling by osteoblasts (which stimulates release of osteocalcin) and osteoclasts. If humans don t have sufficient vitamin D, bones can become brittle, thin, or misshaped. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults. Vitamin D also assists in immune system health. Together with calcium, vitamin D helps to protect elderly from osteoporosis. Normal bone Osteoporosis 7

8 cvd-pharma.com Vitamin K2 in relation to bone health Just as in cardiovascular disease and arterial calcification, the development of osteoporosis shares the common factor, vitamin K deficiency. This leads to inadequate calcium metabolism and utilization. There are at least three vitamin K dependent proteins present in bone and cartilage, including, osteocalcin and matrix Gla-proteins. 5 Osteocalcin is the most abundant non-collagenous protein in bone and a recognized marker for bone formation. Serum levels of osteocalcin are good biochemical marker of the metabolic turnover of bone. 6 Vitamin K2 is needed to carboxylate osteocalcin. Carboxylated osteocalcin is essential for bind calcium effectively to the bone matrix, keeping bones dense and strong. When osteocalcin is produced its inactive. In the absence of vitamin K2, osteocalcin remains inactive and is thus not effective. It results in very little calcium is deposited in bones and this calcium is instead lost into the blood stream increasing the risk of osteoporosis and cardiovascular diseases. Vitamin K2 also stimulates the creation of osteoblasts and restrains the creation of osteoclasts. Vitamin K2, and particularly vitamin K2-7 (MK-7) has a better bioavailability and longer half life, and studies show that this molecule remains in the body for a longer period and is more effective at lower doses, hence is much more bio-effective than K1 for example. During prolonged intake the long half-life permits accumulation of K2 to levels 7-8 fold higher than that seen after one dose. Vitamin K2 (MK-7) is 6 times more potent than vitamin K1, and is also the form in which vitamin K has been found to protect against arterial calcification. 2 The scientific rationale and documentation is that vitamin D stimulates the synthesis of osteocalcin, while vitamin K2 is needed for the carboxylation of osteocalcin. Only the vitamin K2 activated osteocalcin will bind calcium optimally. Vitamin D and vitamin K2 work in synergy helping the body to utilize calcium efficiently. British Medical Journal (BMJ 2005):...Prevention of fractures with calcium and vitamin D is not enough...combining vitamin K, vitamin D and calcium seems ideal... Doctor examining the x-ray of a hip joint replacement patient with osteoporosis. 8

9 Magnesium in relation to bone health Magnesium is just as calcium an essential mineral for healthy bones, teeth and muscles providing the mechanism for contraction and relaxation. Without magnesium, calcium may be not fully utilized and problems may occur leading to e.g. menstrual cramps, arthritis and osteoporosis. Thousands of years ago, our ancestors ate foods low in calcium but high in magnesium. Magnesium was abundant and readily available, in the form seeds, nuts, vegetables and grains. Due to change in diet we now consume more calcium than magnesium. Magnesium and calcium balance each other in the body and are two of the most important minerals that humans need. By combining magnesium with calcium, calcium is easily and quickly absorbed in the body. It has been proven in all osteoporotic patients that the intracellular magnesium content of the erythrocytes is lower then in controls. 7 Several studies show that supplementing with calcium is not enough for optimal bone health. Without enough magnesium, calcium can accumulate in the soft tissues instead of in the bones where we want it. Lack of calcium in bones makes them porous and brittle while excess of calcium in soft tissue impede blood flow. When calcium levels are elevated in the blood it stimulates the hormone calcitonin and suppresses the secretion of the parathyroid hormone (PTH). Calcitonin and PTH are hormones that regulate the levels of calcium in our bones and soft tissues. PTH draws calcium out of the bones, while calcitonin increase calcium in our bones. Magnesium in sufficient amounts determine this delicate balance. 9

10 cvd-pharma.com Calcium that is drawn out from bones by PTH deposits in the soft tissue. Magnesium suppresses PTH and stimulates calcitonin which allocates the calcium to the bones. Too much calcium prevents magnesium from being absorbed. A magnesium rich diet can be helpful both for arthritis and help to prevent osteoporosis. Dr. Guy Abraham, M.D, is a research gynecologist and endocrinologist in premenstrual syndrome and osteoporosis. Dr. Abraham is one of many doctors and biochemists who advocate taking more magnesium to correct calcium deficiency diseases. Dr. Abrahamn has found strong evidence to suggest that women with osteoporosis have deficiency of a chemical that is generated when they take twice as much magnesium as calcium. CVD Ingredients recommendation is not to take large amounts of calcium without an adequate measure of magnesium. Inadequate magnesium levels may either create malabsorption or magnesium deficiency while magnesium taken in adequate levels will radically increase the bodies calcium utilization. According to Dr. Mildred Seelig, executive president of the American College of Nutrition, we need an average of 200mg more then we get from the average diet. Vitamin A The scientific name for vitamin A is retinol. Retinol is essential for maintaining good vision, immune system and bones. Vitamin A is also essential for good skin health and for the reproductive functions in both men and women. Vitamin A is a fat-soluble vitamin just as vitamins, D and K2. Both vitamins, A and D are required for the production of vitamin K2-dependent proteins such as osteocalcin and MGP (matrix Gla-protein). Vitamin K2 then activates those proteins allowing them to do their job which is moving calcium around in the body. Up to 15% of seniors are vitamin A deficient

11 Menacin TM and heart healthy Excess calcium build-up in our cardiovascular system may lead to arterial dysfunction, and the calcium content of arteries is now proven to be more dangerous than elevated cholesterol. Vitamin K2 is required for the carboxylation of the vascular protein matrix Gla-protein (MGP), which is a potent inhibitor of vascular wall and strong heart health. 8 Menacin TM will thus help to improve cardiovascular health. 2 Lack of sufficient amounts of vitamin K2 strongly influences how the body tackles calcium. Bones get depleted of calcium while arteries and cartilage become calcified. At age 80 the average calcium content in the aorta is 140 times greater than the levelsof aortic calcification at age 40. This may relate to a long period of unrecognized vitamin K2 deficiency. Vitamin K2 is unique and its beneficial effects on cardiovascular health have been clearly documented. Just as in osteoporosis the development of cardiovascular disease shares a common factor, vitamin K deficiency. The vitamin K deficiency leads to inadequate calcium metabolism and utilization. The Rotterdam study with 4473 subjects with no history of myocardial infarction studied the effects of vitamin K2 over a period of 10 years. The outcome of consuming 45 mcg dietary K2 daily where impressive. 50% lower arterial calcification 2 50% lower cardiovascular dealth 2 25% lower all cause of mortality 2 Recommended doses of 45 mcg K2 reduce the risk of CVD with about 50! 3 Even smaller doses where proven to be effective. Every 10 mcg reduced the risk of CVD with 9%! 3 Vitamin K2 plays a vital role in the Calcium Paradox by activating crucial proteins such as osteocalcin responsible for bone mineralization and matrix Gla-protein that protects against arterial calcification. 2,10 Inadequate vitamin K2 results in key proteins, osteocalcin and matrix Gla-proteins being inactive and thus ineffective. Vitamin K2 in the form of menaquinone-7 (MK-7) is the vitamin K2 with the best bioavailability and longest half life than any other vitamin K2 form. MK-7 remains in the body for a longer period and is therefore more effective at lower doses, hence is much more bio-effective than vitamin K1 and is also the only form of these two that has been found to protect against arterial calcification.2 K1. Vitamin K2-7 is 6 times more potent than vitamin K1 and is also the only form of these two that has been found to protect against arterial calcification. 2 Omega-3 in relation to heart health Atheromatous plaque contains lipids (cholesterol and fatty acids), variable amount of fibrous connective tissue and calcium. The cardiovascular effects of Omega-3 are widely known. Omega-3 is involved in the lowering of cholesterol levels and by doing so Omega-3 is involved in reducing the risk for atheromatous plaque. By taking Menacin TM Blue individuals reduce cholesterol and calcium levels which makes up the majority of the harmful atheromatous plaque. Easily said Omega-3 takes care of the cholesterol while vitamin K2 takes care of the calcium! 11

12 Short summary Matrix Gla-protein (MGP) MGP is a vitamin K dependent protein. MGP is present in bone, heart, lungs and kidneys. In bone, its production is increased by vitamin D. When produced it s uncarboxylated/inactive. MGP functions to keep the arteries free from calcifications, thereby keeping them flexible and elastic. MGP is used as a prognostic marker for cardiovascular disease. Osteocalcin Osteocalcin is also a vitamin K dependent protein. Osteocalcin is produced by osteoblasts and acts as a hormone in the body. When produced its also uncarboxylated/inactive. Osteocalcin is used as a marker for the bone formation process. Both MGP and Osteocalcin are calcium-binding proteins of the bone matrix. Vitamin D - promotes calcium absorption. / Vitamin D / Vitamin K2 Carboxylates/activates both MGP and Osteocalcin MGP (carboxylated / active form) Osteocalcin (carboxylated form / active form) Carboxylated osteocalcin now fully participate in its Ca 2+ binding process of bone matrix The more vitamin k2 dependent proteins you make, the more calcium you can direct into bone and away from arteries, if you have the K2 to activate those proteins. Vitamin A - Is triggering the body to release the calcium that K2 has liberated from the arteries. When K2 removes calcium from arterial plaque, vitamin A disposes of it. Working together, Vitamin A and D maximize production of osteocalcin and MGP. Magnesium Vitamin K2 is the vitamin that ultimately quides calcium into bones and out of soft tissue. Magnesium on other hand has a balancing effect on calcium metabolism and is just as important as calcium for healthy bones. Magnesium is also essential for the absorption and metabolism of vitamin D. 12

13 Menacin TM is suitable for all ages Modern food production has reduced the level of vitamin K2 in the daily food products, resulting in that the majority of children and adults are vitamin K deficient. Children should take Menacin daily to build bone as effectively as possible, so that they reach maximum peak bone mass before they reach years 9 (see figure 1 page 6). Females are statistically more vulnerable to osteoporosis then men due to initially less bone mass and the acceleration of bone mass loss after menopaus. Females should therefore take Menacin daily before and during menopause, limiting the risk for osteoporosis. Fractures are the most dangerous aspect of osteoporosis and leads often to further disability and early mortality. Men are far from immune to osteoporosis and should also take Menacin daily to limit their risk for both cardiovascular diseases, and at the same time reach optimal bone strength. 13

14 cvd-pharma.com VITAMIN K2 90mcg = Menacin TM Green contains higher amount of vitamin K2-7 contributes to maintenance of normal bones and to normal blood clotting. The effects of vitamin K2-7 are clinically proven. VITAMIN K2 50mcg + CALCIUM 250mg + VITAMIN D3 = 10mcg Menacin TM Red contains an optimal combination of vitamin K2-7, calcium and vitamin D3. This unique combination provides strong synergistic effect and is clinically proven. The active ingredients contribute to maintenance of normal bones. Vitamin K2-7 and calcium contribute normal blood clotting. Calcium and vitamin D3 contribute to normal muscle function. VITAMIN K2 50mcg + CALCIUM 130mg Magnesium 180mg + VITAMIN D3 + VITAMIN A = 10mcg 1mg Menacin TM Purple contains an optimal combination of vitamin K2-7, calcium, magnesium and vitamin D3. Calcium, vitamin K2-7, vitamin D3 and magnesium contribute to maintenance of normal bones and teeth. Calcium + vitamin K contribute to normal blood clotting and calcium + vitamin D3 contribute to normal muscle function. Moreover, vitamin A contributes to the normal function of the immune system, maintenance of normal skin and vision and numerous other beneficial health effects. VITAMIN K2 + OMEGA 3 = 50mcg Simply take 1-2 Menacin TM tablets a day and take control over your calcium! 14

15 CVD Ingredients a reliable supplier CVD Ingredients main focus is to sell vitamin K2-7 as a raw material in different varieties. CVD Ingredients can also offers both branded and white labeled finished formulations produced in a GMP facility within the EU. CVD Ingredient developed the Menacin TM product line to meet market demands for ready vitamin K2-7 formulas. All Menacin TM products have natural vitamin K2-7 as a key ingredient. Menacin TM is divided into colors so that customers can choose the vitamin K2-7 formulation that suits their individual needs. For details and prices please contact CVD Ingredients sales department! Our Vitamin K2-7 ingredient is 100% natural and well documented Novel food Self-affirmed GRAS Extensive safety & toxicity studies Acute toxicity Study Chronic toxicity Study Genotoxicity Protection Study Genotoxicity Study Ames Test LD50 Study Manufactured according to current good manufacturing practice (cgmp) Extensive Stability Studies for all Grades Kosher Certified Halal Certified Soy-Free Water dispersible and oil soluble forms of the product for food and drink use Production is both cgmp and Pharma Grade Product is used in pharmaceutical formulations Continuous Innovation and Technical support Flexibility in response to customer inquiries Inventory maintained as per customer requirements Extensive safety and toxicity studies HACCP Certificate 15

16 cvd-pharma.com ReferenceS 1. Mark J Bolland, P Alan Barber, Robert N Doughty, Barbara Mason, Anne Horne, Ruth Ames, Gregory. Gamble, Andrew Grey, Ian R Reid. BMJ 2008;336: doi: / bmj BE 2. Geleijnse, J.M. et al. 2004: Dietary intake of menaquione is associated with a reduced risk of coronary diseases: The Rotterdam study. AM Soc. Nutr Science. May Nutritinal Epidmiology 3. Gast. GCM at al. A high Menaquione reduces the indennce of coronary heart diseases in woman. J Nutr Met & cardio Nan Kathryn Fuchs, Ph.D. Magnesium a key to calcium absorption. The Nutrition Detective 5. S hearer MJ. Role of Vitamin K and Gla Protein in the patho physiology of Osteoporosis and vascular calcification. Curr Opin Clin Nutr Metab Care 2003; 3: Price PA, Pathemore JG, Deftos LJ. New biochemical marker for bone metabolism. Measurement by radioimmunoassay of bone GLA protein in the plasma of normal subjects and patientswith bone disease. J Clin Invest 1980; 66: Driessens FC. Ned Tijdschr Tandheelkd. Prevention of osteoporosis and pathological calcifications Sep; 100(9):412, Braam LA, Dissel P, Giljsbears BL et al. Assay for human matrix GLA protein serum. Artioscler Thromb vasc Biol. 2000; 20: British Medical Journal (BMJ) 2008 Calcium supplements in healthy post-menopausal women 10. Gilman A. G., Rall T. W., Nies A. S., Taylor P (Eds) Vitamin KIn: Goodman and Gilman s The Pharmacological Basis of Therapeutics (8th Ed.)Pergamon Press; New York / Toronto, pp & Basu TK, Donald EA, Hargreaves JA. Seasonal variation of vitamin A (retinol) status in older men and women. J Am Coll Nutr 1994 Dec, 13(6):

17 CVD Ingredients CVD Ingredients is a Norwegian Public Limited Liability Company (AS) incorporated under the Norwegian Public Limited Liability Companies Act and registred in the Norwegian Register of Business Enterprises with organization number CVD Ingredients is dedicated to promote health and wellness for all with natural and safe ingredients / products. We recognize the importance of the body s own natural mechanisms and utilize all natural ingredients, carefully selected! CVD Ingredients Vision: The vision of the company is to identify and develop a solid and protected business platform within the area of vitamin K2-7. CVD Ingredients has been founded on the basis of existing and prospective market need for high quality vitamin K2-7. The need for such products is triggered by: A strong increase in the market for food supplements and functional food (market segment bone health and cardiovascular health). A positive market development in the pharmaceutical sector related to pharmacological effect of vitamin K2. CVD Ingredients Business Idea: CVD Ingredients overriding business idea is to identify and develop natural ingredients and products for the use in nutraceuticals, pharmaceuticals and cosmetic products. CVD Ingredients shall be an internationally leading company in the natural ingredient sector with the main focus on vitamin K2-7. We will exploit, develop and protect accumulated knowledge within the areas of pharmacology, medicine, nutrition biology and process technology. CVD Ingredients has a unique scientific competence in a crossover field relating to food supplement and pharmacy. This specific expertise is an important asset in early identification of underexploited natural resources. The company focus will be on the development of new ingredients/products, process optimization and development of applications in the core area of the company. Such developments will be used in sale and marketing. The company will develop ingredients and products that are innovative and satisfying for existing market needs. CVD Ingredients R&D focus will be on documentation of vitamin K2 s health effect that can lead to patents and improve the Company s IPR. 17

18 CONTACT President and Chairman Morten Sundstø Phone: Skype: morten.sundsto Sales Michael Ceranka Phone: Skype: michael.ceranka Visiting address CVD Ingredients Drammensveien Oslo Norway