Oxidative Stress, Inflammation
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVitamin K2
(K2VITAL® 1% MCT Oil)
DIETARY_SUPPLEMENTPlacebo
Sunflower oil
Sponsors
Kappa Bioscience AS
NIZO Food Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma ox-LDL | 3 weeks | Dose dependent change in ox-LDL levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma MDA | 3 weeks | Dose dependent change in plasma MDA levels |
| plasma CRP | 3 weeks | Dose dependent change in plasma CRP levels |
| IL-6 | 3 weeks | Dose dependent change in plasma IL-6 levels |
| Phagocytosis capacity | 3 weeks | % positive and MFI of monocytes and granulocytes |
| PBMC gene expression | 3 weeks | Differential Gene Expression analysis (DGE) - Fold change and relative abundance |
Countries
Netherlands
Outcome results
None listed