The objective is to obtain insight into a dose-dependent effect of vitamin K2 on oxidative stress and specific markers of the immune system. The primary objective is to investigate the effect of vitamin K2 on oxidative damage to lipids by measuring…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
Antioxidant and immune modulation in healthy subjects
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate the dose dependent effect of 3-week intervention with vitamin K2
(MK-7) on oxidative damage to lipids by measuring Serum oxidized LDL particles
(OxLDL) in healthy, overweight men and (postmenopausal) women
Secondary outcome
To investigate the dose dependent effect of 3-week intervention with vitamin K2
(MK-7) on serum Malondialdehyde (MDA) levels in healthy, overweight men and
(postmenopausal) women;
To investigate the dose dependent effect of 3-week intervention with vitamin K2
(MK-7) on serum hsCRP and IL6 levels in healthy, overweight men and
(postmenopausal) women;
To investigate the dose dependent effect of 3-week intervention with vitamin K2
(MK-7) on the phagocytotic capacity, as detected in whole blood, in healthy,
overweight men and (postmenopausal) women;
To investigate the dose dependent effect of 3-week intervention with vitamin K2
(MK-7) on gene expression in PBMC in healthy, overweight men and
(postmenopausal) women;
Background summary
Vitamin K is a family of naphthoquinone compounds comprising K1 (phylloquinone)
and several forms of K2 (MKs, menaquinones). Phylloquinone is synthesized
exclusively by plants, algae, and some species of cyanobacteria. Menaquinones
are mainly produced by obligate and facultative anaerobic bacteria.
The difference in structure between K1 and K2 is seen in different absorption
rates, tissue distribution, and bioavailability. Vitamin K has been first
reported for its role as a cofactor for the microsomal enzyme γ-glutamyl
carboxylase (GGCX) ensuring the correct function of vitamin K-dependent hepatic
clotting factors. Although differing in structure, both, K1 and K2 act as
cofactor for the enzyme GGCX.,
More recently, a novel role has been disclosed for vitamin K as an antioxidant
and anti-inflammatory factor, independent of its activity as a cofactor for
GGCX.
The number of clinical studies aiming to evaluate the benefits of the use of
vitamin K2 supplementation in modulating oxidative stress and inflammation is
still limited. To further evaluate these beneficial effects, including their
mechanism of action, additional clinical studies are required.
Study objective
The objective is to obtain insight into a dose-dependent effect of vitamin K2
on oxidative stress and specific markers of the immune system.
The primary objective is to investigate the effect of vitamin K2 on oxidative
damage to lipids by measuring oxidized LDL particles (OxLDL) in plasma in an
older population.
One of the secondary objectives of the study is to investigate the effect of
vitamin K2 on a second marker for oxidative stress, Malondialdehyde (MDA) in
blood, as supportive evidence for protection from oxidative damage. The other
secondary objectives study the effect of vitamin K2 intake on markers for
immune function including: serum levels of hsCRP and IL6, the phagocytotic
capacity in whole blood, and the gene expression in PBMC.
Study design
The study is designed as a randomized, double blinded, placebo controlled, 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.
Intervention
All subjects in this study, will consume 333 µg vitamin K2, 666 µg vitamin K2
and placebo daily for 3 weeks. Each subject will receive each treatment for a
period of 3 weeks with a 3 weeks washout period between treatments.
Study burden and risks
For this study healthy volunteers are selected. There is no direct benefit from
participation, although volunteers will be reimbursed for their time
investment. In total the subjects will visit the research lfacility7 times
(first visit is screening visit). There are no known risks associated with the
consumption of the test products.
Each subject will receive each treatment/ test product for a period of 3 weeks
with a 3 weeks washout period between treatments. There are restrictions with
respect to eating, drinking, and physical activity during the test days and on
the pre-test days.
A faecal sample will be collected twice and blood will be drawn during each
visit to the research facility (7 times). Collection of the stool or blood
sample may be experienced as stressful by some people. By informing people
well, we try to support them in predicting the burden and defining whether this
burden is acceptable to them.
The risk associated with participation in this study is considered minimal.
Silurveien 2B
Oslo 0380
NO
Silurveien 2B
Oslo 0380
NO
Listed location countries
Age
Inclusion criteria
• Age >=50 and <=75;
• 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 health questionnaire (*Gezondheidsvragenlijst*) and
according to the judgment of the study physician;
• Voluntary participation;
• Having given written informed consent;
• Willing to comply with study procedures;
• Accept use of all encoded data, including publication, and the confidential
use and storage of all data for 15 years;
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 3 months 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;
• Personnel of NIZO food research, EB Medical Research and Kappa Bioscience,
their partner and their first and second degree relatives;
• Not having a general practitioner;
• Not willing to accept information-transfer concerning participation in the
study, or information regarding his or her health, like laboratory results and
eventual adverse events to and from his general practitioner
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80827.028.22 |