Clincosm LogoSign in Get a demo

ProteK2t: Antioxidant and Immune Effects of Vitamin K2

Sponsor
NIZO Food Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT05675163
Collaborator
Kappa Bioscience AS (Other)
60
Enrollment
1
Location
3
Arms
5.5
Anticipated Duration (Months)
10.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin K2
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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: Vitamin K2
(K2VITAL® 1% MCT Oil)

Dietary Supplement: Placebo
Sunflower oil
Experimental: Vitamin K2 high dose

666 μg/d Vitamin K2 (MK-7)

Dietary Supplement: Vitamin K2
(K2VITAL® 1% MCT Oil)

Outcome Measures

Primary Outcome Measures

  1. plasma ox-LDL [3 weeks]

    Dose dependent change in ox-LDL levels

Secondary Outcome Measures

  1. plasma MDA [3 weeks]

    Dose dependent change in plasma MDA levels

  2. plasma CRP [3 weeks]

    Dose dependent change in plasma CRP levels

  3. IL-6 [3 weeks]

    Dose dependent change in plasma IL-6 levels

  4. Phagocytosis capacity [3 weeks]

    % positive and MFI of monocytes and granulocytes

  5. PBMC gene expression [3 weeks]

    Differential Gene Expression analysis (DGE) - Fold change and relative abundance

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 NIZO food research Ede Netherlands

Sponsors and Collaborators

  • NIZO Food Research
  • Kappa Bioscience AS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alwine Kardinaal, Principal Scientist Nutrition & Health, NIZO Food Research
ClinicalTrials.gov Identifier:
NCT05675163
Other Study ID Numbers:
  • NL80827.028.22
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Inflammation
Vitamin K
Vitamin K 2

Study Results

No Results Posted as of Jan 11, 2023