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Completed

NCT Number: NCT05675163

Antioxidant and Immune Effects of Vitamin K2

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIZO food research

Ede, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

vitamin K2

Dietary Supplement

(K2VITAL® 1% MCT Oil)

Placebo

Dietary Supplement

Sunflower oil

Primary outcomes

  1. plasma ox-LDL

    Time frame: 3 weeks

    Dose dependent change in ox-LDL levels

Secondary outcomes

  1. plasma MDA

    Time frame: 3 weeks

    Dose dependent change in plasma MDA levels

  2. plasma CRP

    Time frame: 3 weeks

    Dose dependent change in plasma CRP levels

  3. IL-6

    Time frame: 3 weeks

    Dose dependent change in plasma IL-6 levels

  4. Phagocytosis capacity

    Time frame: 3 weeks

    % positive and MFI of monocytes and granulocytes

  5. PBMC gene expression

    Time frame: 3 weeks

    Differential Gene Expression analysis (DGE) - Fold change and relative abundance

Sponsors and collaborators

Lead sponsor

NIZO Food Research

Other

Collaborators

  • Kappa Bioscience AS

Registry information

Official study title

Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study

Acronym: ProteK2t

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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