Oxidative StressProteK2tNCT05675163
Antioxidant and Immune Effects of Vitamin K2
A study testing Vitamin K2 in people with Oxidative Stress and Inflammation, run by NIZO Food Research at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation
- What is being tested?
- Vitamin K2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Nov 2022to 16 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Oxidative Stress, Inflammation
- Being tested
- Vitamin K2, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K2Dietary supplement
(K2VITAL® 1% MCT Oil)
PlaceboDietary supplement
Sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | matched dose of sunflower oil Receives: Dietary Supplement: Placebo |
| Vitamin K2 low dose | Experimental | 333 μg/d Vitamin K2 (MK-7) Receives: Dietary Supplement: Vitamin K2; Dietary Supplement: Placebo |
| Vitamin K2 high dose | Experimental | 666 μg/d Vitamin K2 (MK-7) Receives: Dietary Supplement: Vitamin K2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma ox-LDL
Dose dependent change in ox-LDL levels
Measured: 3 weeks
Secondary outcomes (5)
plasma MDA
Dose dependent change in plasma MDA levels
Measured: 3 weeks
plasma CRP
Dose dependent change in plasma CRP levels
Measured: 3 weeks
IL-6
Dose dependent change in plasma IL-6 levels
Measured: 3 weeks
Phagocytosis capacity
% positive and MFI of monocytes and granulocytes
Measured: 3 weeks
PBMC gene expression
Differential Gene Expression analysis (DGE) - Fold change and relative abundance
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Nov 2022
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- Kappa Bioscience AS
- Responsible party
- Principal investigator, Alwine Kardinaal, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675163
- Sponsor's protocol ID
- NL80827.028.22
- Acronym
- ProteK2t
- Status last verified
- Jun 2023
- First submitted
- 22 Dec 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant and Immune Effects of Vitamin K2 - the ProteK2t Study
- ClinicalTrials.gov ID
- NCT05675163
- Acronym / sponsor ID
- ProteK2t / NL80827.028.22
- Conditions
- Oxidative Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- Kappa Bioscience AS
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebomatched dose of sunflower oil |
| Vitamin K2 low dose | Experimental | Dietary Supplement: Vitamin K2, Dietary Supplement: Placebo333 μg/d Vitamin K2 (MK-7) |
| Vitamin K2 high dose | Experimental | Dietary Supplement: Vitamin K2666 μg/d Vitamin K2 (MK-7) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin K2(K2VITAL® 1% MCT Oil) | Dietary supplement | Vitamin K2 high dose, Vitamin K2 low dose |
| PlaceboSunflower oil | Dietary supplement | Placebo, Vitamin K2 low dose |
Primary outcome
plasma ox-LDL
Time frame: 3 weeks
Dose dependent change in ox-LDL levels
5 secondary outcomes
plasma MDA
Time frame: 3 weeks
plasma CRP
Time frame: 3 weeks
IL-6
Time frame: 3 weeks
Phagocytosis capacity
Time frame: 3 weeks
PBMC gene expression
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K2 in people with Oxidative Stress and Inflammation, run by NIZO Food Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma ox-LDL (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.