Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55095
Enrollment
20
Registered
2020-06-26
Start date
2021-11-22
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitamine K status nutritional status vitamin K status

Interventions

To eat the content of 1 sachet of probiotics mixed with a cup of yoghurt or custard for 12 weeks. Everyday 1 sachet will be used.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 Non-fasting glucose >=7.8 and 6.5 mmol/l or use of statins o Smokers >= 50 years o Estimated glomerular filtration rate > 30 and

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 75 years • Body mass index 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

Design outcomes

Primary

MeasureTime frame
vitamin K status - measured as dephosphorylated uncarboxylated matrix gla protein.

Secondary

MeasureTime frame
vitamin K metabolites in urine and stool

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)