NCT05675163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

December 22, 2022

Last Update Submit

June 15, 2023

Conditions

Oxidative StressInflammation

Outcome Measures

Primary Outcomes (1)

  • plasma ox-LDL

    Dose dependent change in ox-LDL levels

    3 weeks

Secondary Outcomes (5)

  • plasma MDA

    3 weeks

  • plasma CRP

    3 weeks

  • IL-6

    3 weeks

  • Phagocytosis capacity

    3 weeks

  • PBMC gene expression

    3 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

matched dose of sunflower oil

Dietary Supplement: Placebo

Vitamin K2 low dose

EXPERIMENTAL

333 μg/d Vitamin K2 (MK-7)

Dietary Supplement: Vitamin K2Dietary Supplement: Placebo

Vitamin K2 high dose

EXPERIMENTAL

666 μg/d Vitamin K2 (MK-7)

Dietary Supplement: Vitamin K2

Interventions

Vitamin K2DIETARY_SUPPLEMENT

(K2VITAL® 1% MCT Oil)

Vitamin K2 high doseVitamin K2 low dose
PlaceboDIETARY_SUPPLEMENT

Sunflower oil

PlaceboVitamin K2 low dose

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIZO food research

Ede, Netherlands

Location

MeSH Terms

Conditions

Inflammation

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin KNaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesQuinonesPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Scientist Nutrition & Health

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

November 15, 2022

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)