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

Phase 2

Completed

• Conditions: 10047635; vitamine K status; nutritional status; vitamin K status

• Registration Number: NL-OMON55095
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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 Non-fasting glucose >=7.8 and <11.1mmol/l.
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 > 30 and < 60 ml/min

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 <50 or >75 years
• Body mass index < 20 or > 39 kg/m2
• Using vitamin supplements that contain vitamin K, or unwilling to stop
• 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/ colitis Ulcerosa
• Use of more than 3 alcoholic beverages per day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>vitamin K status - measured as dephosphorylated uncarboxylated matrix gla<br /><br>protein.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>vitamin K metabolites in urine and stool</p><br>