A randomized study on probiotics and their effect on vitamin K2 status
- Conditions
- Cardiovascular disease
- Registration Number
- NL-OMON20242
- Lead Sponsor
- VU University Medical Centre Department of Epidemiology & biostatistics Prof. J. Berkhof, department head
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
•Higher cardiovascular risk without type 2 diabetes – at least 1 of the following risk factors:
osystolic blood pressure > 140mm Hg, diastolic blood pressure > 90 mmHg or use of blood pressure lowering medication and/or
o impaired glucose tolerance
oFamily history of cardiovascular disease < 65 years
oTotal cholesterol > 6.5 mmol/l or use of statins
oSmokers = 50 years
oEstimated glomerular filtration rate > 30 and < 60 ml/min
•No gastrointestinal tract problems/stool problems
•Written informed consent
•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 <50 or = 70 years
•Body mass index < 20 or > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).