vitamine status nutritional status vitamin K status
Conditions
Interventions
A daily sachet of 4 gram freeze-dried probiotics producing 180 µg vitamin K2 to
be dissolved in lukewarm water with a slight vanilla taste.
Sponsors
Winclove B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * High cardiovascular risk without type 2 diabetes * at least 1 of the following risk factors: o systolic blood pressure > 140mm Hg, diastolic blood pressure > 90 mmHg or use of blood pressure lowering medication and/or o impaired glucose tolerance * 2 hour glucose levels of 7.8 to 11.0 mmol/L after 75 gram oral glucose tolerance test o Family history of cardiovascular disease 6.5 mmol/l or use of statins o Smokers * 50 years o Estimated glomerular filtration rate
Exclusion criteria
Exclusion criteria: * Pregnancy, lactation or a female planning to conceive within the study period * Diabetes of any type. * Age 39 kg/m2 * Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The main study parameter is the difference in vitamin K status as assessed by plasma dp-ucMGP between the 2 groups after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints after 12 weeks Vitamin K metabolites in 24-urine collection: metabolites 5C en 7C-aglycone. Vitamin K metabolites in stool: vitamin K1 and MK4 and MK-7 after 12 weeks in participants. | — |
Countries
Netherlands
Outcome results
None listed