Antioxidant and Immune Effects of Vitamin K2

Inflammation Clinical Trial

— ProteK2t  

Official title:

Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675163
• Other study ID #: NL80827.028.22
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: May 16, 2023

Study information

• Verified date: June 2023
• Source: NIZO Food Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• Vitamin K2
(K2VITAL® 1% MCT Oil)
• Placebo
Sunflower oil

Locations

Country	Name	City	State
Netherlands	NIZO food research	Ede

Sponsors (2)

Lead Sponsor	Collaborator
NIZO Food Research	Kappa Bioscience AS

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma ox-LDL	Dose dependent change in ox-LDL levels	3 weeks
Secondary	plasma MDA	Dose dependent change in plasma MDA levels	3 weeks
Secondary	plasma CRP	Dose dependent change in plasma CRP levels	3 weeks
Secondary	IL-6	Dose dependent change in plasma IL-6 levels	3 weeks
Secondary	Phagocytosis capacity	% positive and MFI of monocytes and granulocytes	3 weeks
Secondary	PBMC gene expression	Differential Gene Expression analysis (DGE) - Fold change and relative abundance	3 weeks