A randomized pilot study on probiotics and their effect on vitamin K2 status

Phase 2

Withdrawn

Conditions: vitamine status
nutritional status
vitamin K status
10047635

Registration Number: NL-OMON46101

Lead Sponsor: Winclove B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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 < 65 years
o Total cholesterol > 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

Exclusion Criteria

* Pregnancy, lactation or a female planning to conceive within the study period
* 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The main study parameter is the difference in<br /><br>vitamin K status as assessed by plasma dp-ucMGP between the 2 groups after 12<br /><br>weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints after 12 weeks<br /><br>Vitamin K metabolites in 24-urine collection: metabolites 5C en 7C-aglycone.<br /><br>Vitamin K metabolites in stool: vitamin K1 and MK4 and MK-7 after 12 weeks in<br /><br>participants.</p><br>