Clinical trial NCT05675163: Antioxidant and Immune Effects of Vitamin K2
Official title: Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Inflammation
Lead sponsor: NIZO Food Research
Sponsor class: OTHER
Collaborators: name: Kappa Bioscience AS
First posted: 2023-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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;

Primary outcomes:
measure: plasma ox-LDL
timeFrame: 3 weeks
Secondary outcomes:
measure: plasma MDA
timeFrame: 3 weeks
measure: plasma CRP
timeFrame: 3 weeks
measure: IL-6
timeFrame: 3 weeks
measure: Phagocytosis capacity
timeFrame: 3 weeks
measure: PBMC gene expression
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: NIZO food research
Study officials:
References: