To investigate the effect of probiotics for 12 weeks on vitamin K status vs placebo.
ID
Source
Brief title
Condition
- Other condition
- Vitamin related disorders
Synonym
Health condition
vitamine K status
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
vitamin K status - measured as dephosphorylated uncarboxylated matrix gla
protein.
Secondary outcome
vitamin K metabolites in urine and stool
Background summary
Healthy gut bacteria are also known as probiotics and stimulate gut health and
help the immune system. Vitamin K status is the average of vitamin K for a
longer period. Certain probiotics can produce vitamin K. Vitamin K is essential
for the activation of certain proteins. These proteins are involved in vascular
health to halt vascular calcification. Vascular calcification is a strong risk
factor for cardiovascular disease. At this moment, there is no effective
intervention to halt vascular calcification. Vitamin K can be a novel solution.
Study objective
To investigate the effect of probiotics for 12 weeks on vitamin K status vs
placebo.
Study design
Randomized-controlled double blind study
Intervention
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.
Study burden and risks
Participation to this study is completely voluntary. Study participants will be
requested to use 1 sachet of probiotics daily for 12 weeks. The probiotics
should be mixed with a cup of yoghurt or custard and the mixture should be
eaten. The participants will be asked to go to the research center for 4 times.
The first visit is the screening to check if participants are eligible. For the
other 3 visits participants will be asked to bring 24-hour urine and a stool
sample. During these visits a blood sample will be drawn by means of
venapuncture, during the screening visit blood will be drawn by means of a
fingerprick.
The use of probiotics can cause a temporarily change in bowel movements, which
will normally stabilize within 2 weeks. The blood drawn can cause a small
bruise. All probiotic species are already on the market and available over the
counter. To conclude, the risks for this study are minimal.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71758.029.19 |
| Other | NTR (TC = 7505) |