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Made With Vitamin K

Colorcon
 
Kaneka

As studies continue to confirm vitamin K’s benefits, suppliers prepare for its appearance in a growing number of supplement categories.

Vitamin K refers to a group of chemically similar fat-soluble compounds called naphthoquinones. According to Natural Standard, vitamin K1 (phytonadione) is the natural form of vitamin K found in plants and acquired primarily through dietary consumption. Foods that contain vitamin K include green leafy vegetables, such as spinach and parsley; vegetables in the Brassica genus, including cabbage and kale; and fruits, such as avocado, kiwi and grapes. Vitamin K2 compounds (menaquinones) are formed by bacteria in the gut and make up a smaller amount of the daily requirement for vitamin K. 

Vitamin K functions in the body as a blood coagulant and is used in the liver to make vitamin K-dependent clotting factors. Therefore, vitamin K is often given to patients who have coagulation and bleeding disorders, or to newborns with hemorrhagic disease.

This vitamin also plays a role in bone health, since the body needs vitamin K to utilize calcium to build bone, according to the University of Maryland Medical Center. Evidence has shown that vitamin K improves bone health and reduces risk of bone factures, especially in postmenopausal women who are at risk for osteoporosis.1 

Further, the vitamin has proven beneficial for heart health. “It activates both vitamins and minerals that support bone health and it helps support healthy arteries for cardiovascular benefit,” said Dan Murray, vice president of business development at New Jersey-based Xsto Solutions, LLC, a company that partners with Kappa BioScience of Norway to produce specialty ingredients, including vitamin K. 

In healthy adults, vitamin K deficiencies are rare, but can be caused by malnutrition, or by conditions that block absorption of vitamins, such as a biliary obstruction or celiac disease.

In the Market 

The market for vitamin K is growing quickly, approaching 10 tons annually in the U.S., according to Eric Anderson, global vice president of sales and marketing for New Jersey-based NattoPharma Inc., a company focusing on vitamin K2 as menaquinone-7 (MK-7).

“Today the market is still nascent, with natural K2 found mostly in bone-building products in the natural products channel,” he said, adding that he fully expects K2 to grow in calcium products in food, drug and mass, as well as other channels like practitioners.

K1 & K2 

Vitamin K1 is the oldest and most commonly used form, according to Murray. Vitamin K1 is what contributes to the coagulation of blood, a feature that can be beneficial for some, but harmful to others. “This is a normal metabolic action, but many people need to avoid coagulation promoters due to heart and other health issues,” he said.

To that end, several years ago vitamin K2 as MK4 was isolated to help reduce the unwanted side effects of K1 so more people could supplement with vitamin K. But the solution presented its own drawbacks, according to Murray. “While this was an improvement over K1, vitamin K2MK4 has a very short half-life or biological stability.” 

The short half-life of vitamin K2MK4 leads to higher use rates of up to 1,000 times more, and still leaves consumers lacking stable dosing regimens. “More recently, K2 as MK7 was made commercially available. K2MK7 addresses the nutritional need for vitamin K, but significantly reduces the unwanted side effects of K1 and offers far better stability than K2 as MK4,” said Murray. “More populations can now safely supplement with vitamin K2MK7.” 

K2 works by activating the vitamin K-dependent proteins osteocalcin and matrix GLA protein or MGP, respectively, said Vladimir Badmaev, MD, PhD, head of R&D with NattoPharma ASA in Oslo, Norway. “Specifically, the vitamin K2 variety MK-7 has been shown to help improve bone mineral density and strength, as well as to prevent against arterial stiffening through blocking calcium deposits,” he said. “Vitamin K2 does this via active forms of osteocalcin and MGP, ensuring calcium goes where it does its good work (bones) and keeps it away from where it does harm (arteries).” 

Incorporating Vitamin K 

Vitamin K2MK7 can be a stand-alone product or incorporated into multivitamins, as well as vitamin-mineral combinations. “[It] has wonderful potential in an array of formulations,” said Xsto’s Murray.

Xsto Solutions is the North American distribution partner for Kappa BioScience of Norway, which is launching a new coated form of K2MK7. According to Murray, the coating of Kappa’s new K2VITAL Delta provides better stability during formulation and shelf-life when vitamin K is mixed with calcium and magnesium, which are both beneficial for bone health. Kappa’s Vitamin K2MK7 is either made in the U.S. or in Denmark, depending on the form.

As for NattoPharma, the company formulates MenaQ7 Crystals, which are pure, natural, all-trans MK-7, providing the most potent vitamin K2 available, the company stated. “MenaQ7 Crystals is a soy-free fermentation technology product subject to a proprietary process of purification, concentration and crystallization,” said Badmaev. “The strain of microorganism used in the fermentation/ production of the new MenaQ7 brand of menaquinon-7 is Bacillus licheniformis, a non-toxigenic and nonpathogenic strain.” 

Anderson said he sees vitamin K being used in bone-building products today, but that heart health will probably be the most important future nutritional application. “Only MenaQ7 has been validated for improving arterial elasticity,” he said. “Atherosclerosis, or hardening of the arteries, is the leading cause of coronary health disease and mortality in Western population.” 

He also predicts that multivitamins will begin to include vitamin K2 as it is now recognized that vitamin K2, and not K1, is active outside the liver and provides benefits for bone and heart health. “I personally have a goal to get K2 in children’s vitamins and food,” he said. “Children have the greatest need for K2 to build a healthy skeleton with peak bone mass achieved in the early 20s. Without K2, kids will not realize optimal peak bone mass.” 

Research 

Kappa BioScience has run a human bioequivalence study to ensure both safety and efficacy of its K2VITAL product. “Furthermore, Kappa has run hundreds of samples to determine stability of the original K2VITAL and the new K2VITAL Delta for us with minerals,” said Murray.

According to Anderson, NattoPharma ASA continually invests in clinical research to validate efficacy for bone and heart health.

Badmaev added that a recently completed prospective, randomized study in patients with chronic renal disease evaluated the cardiovascular effects of oral administration of K2 (MenaQ7 brand) plus vitamin D, compared to vitamin D alone. In this six-month study, the progression of coronary artery calcification index and common carotid antimi media thickness—both markers of calcium deposits in arteries detected with computerized tomograph—showed a slower progression of the calcification in the K2/vitamin D group than in the vitamin D group alone. “Therefore, calcium and vitamin D supplements should not be avoided, but complemented with vitamin K2 supplementation,” he said.

Another double-blind, randomized, clinical trial, published in Osteoporosis International, investigated the effect of supplemental MK-7 (MenaQ7) over three years in a group of 244 post-menopausal women. Researchers determined that a daily dose of 180 mcg MK-7 was able to improve bone mineral density, bone strength and cardiovascular health, notably arterial structure, according to Badmaev. “Regular intake of vitamin K2 has been shown to lower the risk of vascular damage because it activates Matrix Gla Protein (MGP), which inhibits calcium from depositing in the vessel walls,” he said. “Therefore, calcium is available for other multiple roles in the body, leaving the arteries healthy and flexible.” 

Finally, another study conclusion was announced this past summer. The outcome of the study, sponsored by NattoPharma, was presented at the 13th International Nutrition and Diagnostics Conference in Olomouc, Czech Republic.

“Researchers found that a novel property of vitamin K2 (MenaQ7 Crystals) prevents inflammation by inhibiting proinflammatory markers produced by white blood cells,” said Badmaev. “This is an important finding because chronic inflammatory reactions in the body are in underlying age-related conditions including cardiovascular disease and osteoporosis.” This abstract will be published in the Journal of the Science of Food and Agriculture and the Nutrients.

Reference:

1 Bugel S. Vitamin K and bone health in adult humans. Vitam Horm. 2008;78:393-416.

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Kaneka
 
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