vitamin K status, MGP, cardiovascular risk
Conditions
Interventions
A daily sachet of 4 gram dried multispecies probiotics or placebo
Sponsors
VU medical center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: • Participants of previous studies who provided written consent to be contacted to participate in future studies • 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 < 60 ml/min • No gastrointestinal tract problems/stool problems • Written informed consent
Exclusion criteria
Exclusion criteria: • Pregnancy, lactation or a female planning to conceive within the study period • Any significant medical reason for exclusion as determined by the investigator • Unable to give written informed consent • Unable to speak, read and/or write Dutch • Diabetes of any type. • Age 39 kg/m2 • Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomization. • Using probiotic supplements • Natto or goose liver consumers • Use of vitamin K antogonists such as warfarin, acenocoumarol or coumarin derivates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vitamin K status as measured by dephosphorylated uncarboxylated matrix gla protein concentrations | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed