Antioxidant and Immune Effects of Vitamin K2

Study Overview
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Brief Summary
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The aim of the study is to obtain insight into a dose-dependent effect of vitamin K2 on oxidative stress and specific markers of the immune system.

Official Title
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Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study

Conditions
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Oxidative Stress, Inflammation

Intervention / Treatment
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* Dietary Supplement: Vitamin K2
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 the health questionnaire and according to the judgment of the study physician; Voluntary participation; Having given written informed consent; Willing to comply with study procedures; 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 month 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;

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3 way crossover trial for evaluating the effect on oxidative stress markers. The first study period, is also used as a parallel study for studying the effect on immune markers.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>matched dose of sunflower oil | Dietary Supplement: Placebo<br>* Sunflower oil<br>|
| Experimental: Vitamin K2 low dose<br>333 μg/d Vitamin K2 (MK-7) | Dietary Supplement: Vitamin K2<br>* (K2VITAL® 1% MCT Oil)<br>Dietary Supplement: Placebo<br>* Sunflower oil<br>|
| Experimental: Vitamin K2 high dose<br>666 μg/d Vitamin K2 (MK-7) | Dietary Supplement: Vitamin K2<br>* (K2VITAL® 1% MCT Oil)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma ox-LDL | Dose dependent change in ox-LDL levels | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma MDA | Dose dependent change in plasma MDA levels | 3 weeks | 
| plasma CRP | Dose dependent change in plasma CRP levels | 3 weeks | 
| IL-6 | Dose dependent change in plasma IL-6 levels | 3 weeks | 
| Phagocytosis capacity | % positive and MFI of monocytes and granulocytes | 3 weeks | 
| PBMC gene expression | Differential Gene Expression analysis (DGE) - Fold change and relative abundance | 3 weeks |