Antioxidant and Immune Effects of Vitamin K2

Not Applicable

Completed

• Conditions: Oxidative Stress; Inflammation
• Interventions: Dietary Supplement: Vitamin K2; Dietary Supplement: Placebo

• Registration Number: NCT05675163
• Lead Sponsor: NIZO Food Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2023-01-09
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin K2 low dose	Placebo	333 μg/d Vitamin K2 (MK-7)
Placebo	Placebo	matched dose of sunflower oil
Vitamin K2 high dose	Vitamin K2	666 μg/d Vitamin K2 (MK-7)
Vitamin K2 low dose	Vitamin K2	333 μg/d Vitamin K2 (MK-7)

Primary Outcome Measures

Name	Time	Method
plasma ox-LDL	3 weeks	Dose dependent change in ox-LDL levels

Secondary Outcome Measures

Name	Time	Method
plasma CRP	3 weeks	Dose dependent change in plasma CRP levels
IL-6	3 weeks	Dose dependent change in plasma IL-6 levels
plasma MDA	3 weeks	Dose dependent change in plasma MDA levels
Phagocytosis capacity	3 weeks	% positive and MFI of monocytes and granulocytes
PBMC gene expression	3 weeks	Differential Gene Expression analysis (DGE) - Fold change and relative abundance

Trial Locations

Locations (1)

NIZO food research; 🇳🇱 Ede, Netherlands