Antioxidant and immune modulation in healthy subjects antioxidant effects immune modulation
Conditions
Interventions
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 p
Sponsors
Kappa Bioscience AS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=50 and =25 and
Exclusion criteria
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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
Netherlands
Outcome results
None listed