Antioxidant and Immune Effects of Vitamin K2

NCT ID: NCT05675163

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2023-05-16

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.

Conditions

Oxidative Stress; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

matched dose of sunflower oil

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Sunflower oil

Vitamin K2 low dose

333 μg/d Vitamin K2 (MK-7)

Group Type: EXPERIMENTAL

Vitamin K2

Intervention Type: DIETARY_SUPPLEMENT

(K2VITAL® 1% MCT Oil)

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Sunflower oil

Vitamin K2 high dose

666 μg/d Vitamin K2 (MK-7)

Group Type: EXPERIMENTAL

Vitamin K2

Intervention Type: DIETARY_SUPPLEMENT

(K2VITAL® 1% MCT Oil)

Interventions

Vitamin K2

(K2VITAL® 1% MCT Oil)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Sunflower oil

Intervention Type: DIETARY_SUPPLEMENT

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kappa Bioscience AS

UNKNOWN

Sponsor Role: collaborator

NIZO Food Research

OTHER

Sponsor Role: lead

Responsible Party

Alwine Kardinaal

Principal Scientist Nutrition & Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NIZO food research

Ede, , Netherlands

Countries

Netherlands

Other Identifiers

NL80827.028.22

Identifier Type: -

Identifier Source: org_study_id