The study of antioxidant and immune effects of Vitamin K2 (ProteK2t)

illustrative image

The company NIZO Food Research in cooperation with Kappa Bioscience AS  is commencing recruitment for the clinical trial of the Antioxidant and Immune Effects of Vitamin K2. 

The conditions are Oxidative Stress, Inflammation. A new clinical trial is recruiting patients in the Netherlands. The trial officially began on the November 15, 2022 and is planned to complete on May 2023.

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.

The population that can be enrolled into this study includes:

  • 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 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.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05675163.

Upcoming Clinical Trials