Antioxidant and Immune Effects of Vitamin K2 (ProteK2t)

Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin K2

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joyce Schloesser, MSc; Phone Number: +31618662999; Email: joyce.schloesser@nizo.com

Study Locations

• Netherlands
  • Ede, Netherlands
    • NIZO food research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; matched dose of sunflower oil	Dietary supplement: Placebo; Sunflower oil
Experimental: Vitamin K2 low dose; 333 μg/d Vitamin K2 (MK-7)	Dietary supplement: Placebo; Sunflower oil; Dietary supplement: Vitamin K2; (K2VITAL® 1% MCT Oil)
Experimental: Vitamin K2 high dose; 666 μg/d Vitamin K2 (MK-7)	Dietary supplement: Vitamin K2; (K2VITAL® 1% MCT Oil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma ox-LDL	Dose dependent change in ox-LDL levels	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NIZO Food Research
• Collaborators: Kappa Bioscience AS

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): May 16, 2023
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Micronutrients; Vitamins; Antifibrinolytic Agents; Hemostatics; Coagulants; Vitamin K; Vitamin K 2
• Other Study ID Numbers: NL80827.028.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No