An interventional study of Placebo-Control and Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d) in Obesity, Insulin Resistance and Insulin Sensitivity, sponsored by Augusta University. Status unknown at 1 site in United States. Open to participants aged 8 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Augusta University · Not applicable, Interventional, and Prevention
The undercarboxylated fractions of the two vitamin K-dependent proteins osteocalcin and matrix Gla protein have been shown to play key roles in type 2 diabetes and cardiovascular disease (at least in mouse models). Clinical trials are needed to isolate the effects of vitamin K manipulation on carboxylation of these two proteins (osteocalcin and matrix GLA protein) and their subsequent effects on markers of diabetes and cardiovascular disease risk. The purpose of this pilot randomized, double-blind, placebo-controlled trial in children is to estimate the effective dose of vitamin K2 (menaquinone-7) supplementation (to improve carboxylation of both osteocalcin and matrix Gla protein), and whether it can have an effect on markers associated with diabetes and cardiovascular disease risk.
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Exclusion Criteria:
The placebo-control group will take one placebo softgel capsules every day for 8 weeks.
Dietary Supplement: Placebo-Control
The low-dose vitamin K2 group will take one 45-mcg vitamin K2 softgel capsule and one placebo softgel capsule every day for 8 weeks.
Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d)
The high-dose vitamin K2 group will take one 90-mcg vitamin K2 softgel capsules every day for 8 weeks.
Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)
one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
Also known as: menaquinone-7
one 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
Also known as: menaquinone-7
Change in serum lipid concentrations
To determine if vitamin K supplementation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner.
Time frame: 8 weeks
Change in insulin sensitivity
To determine if vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour glucose tolerance test by using the oral glucose minimal model.
Time frame: 8 weeks
Change in beta-cell function
To determine if vitamin K supplementation improves insulin sensitivity in a dose-dependent manner. Beta-cell function, as assessed by dynamic beta-cell responsitivity, will be calculated from plasma glucose and C-peptide concentrations measured during a 2-hour glucose tolerance test by using the oral C-peptide minimal model.
Time frame: 8 weeks
Change in coagulation
Coagulation-related parameters (i.e., prothrombin time and activated partial thromboplastin time) will be assessed at baseline and 8 weeks to assess clotting function.
Time frame: 8 weeks
Change in arterial stiffness (pulse wave velocity)
Arterial stiffness, as measured by pulse wave velocity (PWV), will be assessed at baseline and 8 weeks to explore whether change in arterial stiffness is influenced by vitamin K2 supplementation.
Time frame: 8 weeks
Change in endothelial function (Flow-mediated dilation)
Endothelial function, as measured by flow-mediated dilation (FMD), will be assessed at baseline and 8 weeks to explore whether change in endothelial function is influenced by vitamin K2 supplementation.
Time frame: 8 weeks
Effects of sex, race, bone age, and pubertal stage on changes in glucosemetabolism (insulin sensitivity and beta-cell function)
Moderation effects of sex, race, bone age, and pubertal stage in the associations of vitamin K-induced changes in carboxylation of osteocalcin on markers of glucose metabolism will be determined.
Time frame: 8 weeks
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Augusta University