Cardiovascular disease
Conditions
Interventions
This study aims to assess whether a daily sachet of probiotics producing vitamin K2 for 12 weeks vs placebo improves vitamin K status in middle-aged adults between 50-70 years with high risk of develo
Sponsors
VU University Medical Centre Department of Epidemiology & biostatistics Prof. J. Berkhof, department head
Eligibility
Inclusion criteria
Inclusion criteria: • Higher 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 o Family history of cardiovascular disease 6.5 mmol/l or use of statins o Smokers = 50 years o Estimated glomerular filtration rate > 30 and < 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 • Use of antibiotics • Colectomy • Crohn's disease/ Ulcerative Colitis • Use of more than 3 alcoholic beverages per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effect of a daily sachet of 4 gram freeze-dried probiotics producing 180 µg vitamin K2 on plasma dp-ucMGP concentrations after 12 weeks in participants aged (50-70 years). | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of a daily sachet of 4 gram freeze-dried probiotics producing 180 µg vitamin K2 in 24-hour urine on vitamin K metabolites 5C en 7C-aglycone, and vitamin K1 and MK4 and MK-7 in stool samples after 12 weeks in participants aged (50-70 years). | — |
Contacts
Public ContactMirthe Muilwijk
Department of Epidemiology & Datascience, Amsterdam UMC location VUmc
Outcome results
None listed