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CompletedNCT05675163ProteK2tUpdated Jun 18, 2023

Antioxidant and Immune Effects of Vitamin K2

An interventional study of Vitamin K2 and Placebo in Oxidative Stress and Inflammation, sponsored by NIZO Food Research. Completed at 1 site in Netherlands. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by NIZO Food Research · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Oxidative Stress
  • Inflammation

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03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

NIZO Food Research is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts 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

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;
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    matched dose of sunflower oil

    Dietary Supplement: Placebo

  • Experimental
    Vitamin K2 low dose

    333 μg/d Vitamin K2 (MK-7)

    Dietary Supplement: Vitamin K2 · Dietary Supplement: Placebo

  • Experimental
    Vitamin K2 high dose

    666 μg/d Vitamin K2 (MK-7)

    Dietary Supplement: Vitamin K2

Interventions

  • Dietary supplementVitamin K2

    (K2VITAL® 1% MCT Oil)

  • Dietary supplementPlacebo

    Sunflower oil

06

What researchers measure

Primary outcomes

  1. plasma ox-LDL

    Dose dependent change in ox-LDL levels

    Time frame: 3 weeks

Secondary outcomes

  1. plasma MDA

    Dose dependent change in plasma MDA levels

    Time frame: 3 weeks

  2. plasma CRP

    Dose dependent change in plasma CRP levels

    Time frame: 3 weeks

  3. IL-6

    Dose dependent change in plasma IL-6 levels

    Time frame: 3 weeks

  4. Phagocytosis capacity

    % positive and MFI of monocytes and granulocytes

    Time frame: 3 weeks

  5. PBMC gene expression

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

    Time frame: 3 weeks

07

Study locations

1 site
  • NIZO food research
    Ede, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05675163
Lead sponsor
NIZO Food Research
Collaborators
Kappa Bioscience AS
Responsible party
Alwine Kardinaal (Principal Scientist Nutrition & Health, NIZO Food Research) — Principal investigator
First posted
Jan 9, 2023
Start date
Nov 15, 2022
Primary completion
May 16, 2023
Completion
May 16, 2023
Last update
Jun 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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