NL-OMON46101
Withdrawn
Phase 2
A randomized pilot study on probiotics and their effect on vitamin K2 status - ProVitaK
Winclove B.V.0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- 10047635
- Sponsor
- Winclove B.V.
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 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.
Outcomes
Primary Outcomes
Not specified
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