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Bioequivalence
Bioavailability in humans, comparison between K2VITAL™ and natto soy based MK-7
A bioavailability study has been conducted according to Good Clinical Practice (GCP) for the comparison of K2VITAL and natto soy based fermented MK-7.
The objective of the single dose study was to compare the bioavailability of K2VITAL™ and natto based MK-7.
Testing of K2VITAL™ and natto soy based MK-7 in 14 humans demonstrated that K2VITAL™ is bioequivalent to natto soy based MK-7.
Steady state studies, comparison between K2VITAL™ and natto soy based MK-7
A steady state study over 6 weeks was conducted in 46 volunteers according to Good Clinical Practice (GCP). Blood levels of vitamin K2, MK-7 were analyzed during a 6 weeks period after treatment with K2VITAL™ or natto soy based MK-7. There was no difference in blood level of MK-7 between the two groups. The study demonstrated that K2VITAL™ is bioequivalent to MK-7 in natto soy based product.
Analysis of MK-7 in blood has been performed by Vitas AS, Norway that has developed a validated method for serum measurements of MK-7, according to "Guidance for Industry" for Bioanalytical Method Validation (FDA 2001).
Effects on Osteocalcin, comparison between K2VITAL™ and natto soy based MK-7
The objective of this study was to demonstrate the biological effects of K2VITAL™.
The volunteers in the steady state study were tested for blood levels of under-carboxylated osteocalcin (the inactivate form of osteocalcin). Under-carboxyalted osteocalcin is a measure for vitamin K status; high vitamin K concentration in blood = low concentration of under-caboxylated osteocalcin.
After treatment with K2VITAL™ or natto soy based MK-7 during a six week period, the results demonstrated that K2VITAL™ and natto soy based products had the same capacity to reduce the level of the under-caboxylated osteocalcin in blood.
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| K2VITAL is tested in clinical trials according to GCP and blood analysis of MK-7 has been performed by validated analytical methods for serum measurement of MK-7. |
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