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Antioxidant and Immune Effects of Vitamin K2 (ProteK2t)

Primary Purpose

Oxidative Stress, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Vitamin K2
Placebo
Sponsored by
NIZO Food Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oxidative Stress

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • NIZO food research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Vitamin K2 low dose

Vitamin K2 high dose

Arm Description

matched dose of sunflower oil

333 μg/d Vitamin K2 (MK-7)

666 μg/d Vitamin K2 (MK-7)

Outcomes

Primary Outcome Measures

plasma ox-LDL
Dose dependent change in ox-LDL levels

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2022
Last Updated
June 15, 2023
Sponsor
NIZO Food Research
Collaborators
Kappa Bioscience AS
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1. Study Identification

Unique Protocol Identification Number
NCT05675163
Brief Title
Antioxidant and Immune Effects of Vitamin K2
Acronym
ProteK2t
Official Title
Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NIZO Food Research
Collaborators
Kappa Bioscience AS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3 way crossover trial for evaluating the effect on oxidative stress markers. The first study period, is also used as a parallel study for studying the effect on immune markers.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matched dose of sunflower oil
Arm Title
Vitamin K2 low dose
Arm Type
Experimental
Arm Description
333 μg/d Vitamin K2 (MK-7)
Arm Title
Vitamin K2 high dose
Arm Type
Experimental
Arm Description
666 μg/d Vitamin K2 (MK-7)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin K2
Intervention Description
(K2VITAL® 1% MCT Oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Sunflower oil
Primary Outcome Measure Information:
Title
plasma ox-LDL
Description
Dose dependent change in ox-LDL levels
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
plasma MDA
Description
Dose dependent change in plasma MDA levels
Time Frame
3 weeks
Title
plasma CRP
Description
Dose dependent change in plasma CRP levels
Time Frame
3 weeks
Title
IL-6
Description
Dose dependent change in plasma IL-6 levels
Time Frame
3 weeks
Title
Phagocytosis capacity
Description
% positive and MFI of monocytes and granulocytes
Time Frame
3 weeks
Title
PBMC gene expression
Description
Differential Gene Expression analysis (DGE) - Fold change and relative abundance
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
NIZO food research
City
Ede
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Antioxidant and Immune Effects of Vitamin K2

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