Antioxidant and immune effects of vitamin K2

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• Age >=50 and <=75;
• Self-reported postmenopausal (at least one year after the final menstruation)
• BMI >=25 and <=32 kg/m2;
• Plasma dp-ucMGP concentration in highest 50-66% of the screened population
• Non-smoking (defined as not smoking currently and not having smoked (at all)
in the year before study start);;
• Healthy as assessed by health questionnaire (*Gezondheidsvragenlijst*) and
according to the judgment of the study physician;
• Voluntary participation;
• Having given written informed consent;
• Willing to comply with study procedures;
• Accept use of all encoded data, including publication, and the confidential
use and storage of all data for 15 years;

Exclusion Criteria

• Plasma dp-ucMGP concentration >1000 pmol/L at screening
• Treatment with oral antibiotics within 2 months of the start of the study
• Any vaccination in the month before study start or any scheduled vaccination
during the study period
• Use of antioxidant or vitamin K and D supplements;
• Use of antioxidant or vitamin K and D supplements in the 3 months before the
start of the study;
• Use of aspirin or medication with established antioxidant or
anti-inflammatory properties;
• Use of medication that interferes with vitamin K or blood coagulation;
• Use of statins to reduce level of low-density lipoprotein cholesterol in the
blood;
• Hyperlipidaemia, diabetes, hypertension, intestinal disease, diseases with an
inflammation component;
• Hormone replacement therapy in women;
• Follow a vegetarian or vegan diet;
• Participation in any clinical trial including blood sampling and/or
administration of substances up to 30 days before day 1 of this study;
• Alcohol consumption for men > 28 units/week and >4/day; for women: >21
units/week and >3/day;
• Reported unexpected weight loss or weight gain of > 3 kg in the month prior
to pre-study screening, or intention to lose weight during the study period;
• Reported slimming or medically prescribed diet;
• Recent blood donation (<1 month prior to Day 01 of the study);
• Not willing to give up blood donation during the study;
• Personnel of NIZO food research, EB Medical Research and Kappa Bioscience,
their partner and their first and second degree relatives;
• Not having a general practitioner;
• Not willing to accept information-transfer concerning participation in the
study, or information regarding his or her health, like laboratory results and
eventual adverse events to and from his general practitioner

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate the dose dependent effect of 3-week intervention with vitamin K2<br /><br>(MK-7) on oxidative damage to lipids by measuring Serum oxidized LDL particles<br /><br>(OxLDL) in healthy, overweight men and (postmenopausal) women</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate the dose dependent effect of 3-week intervention with vitamin K2<br /><br>(MK-7) on serum Malondialdehyde (MDA) levels in healthy, overweight men and<br /><br>(postmenopausal) women;<br /><br><br /><br>To investigate the dose dependent effect of 3-week intervention with vitamin K2<br /><br>(MK-7) on serum hsCRP and IL6 levels in healthy, overweight men and<br /><br>(postmenopausal) women;<br /><br><br /><br>To investigate the dose dependent effect of 3-week intervention with vitamin K2<br /><br>(MK-7) on the phagocytotic capacity, as detected in whole blood, in healthy,<br /><br>overweight men and (postmenopausal) women;<br /><br><br /><br>To investigate the dose dependent effect of 3-week intervention with vitamin K2<br /><br>(MK-7) on gene expression in PBMC in healthy, overweight men and<br /><br>(postmenopausal) women;</p><br>