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| ID | Type | Description | Link |
|---|---|---|---|
| 16GRNT31090037 | Other Grant/Funding Number | American Heart Association |
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Animal studies have found that vitamin K-dependent proteins matrix Gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. However, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. Vitamin K supplementation presents an opportunity to test the hypothesized link between the vitamin K-dependent proteins and markers of lipid and glucose metabolism. The investigators will conduct an 8-week vitamin K intervention (to manipulate carboxylation of matrix Gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. Sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin K (menaquinone-7).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-Control | Placebo Comparator | The placebo-control group will take two placebo softgel capsules every day for 8 weeks. |
|
| Low-Dose Vitamin K2 (45-mcg/d) | Active Comparator | 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. |
|
| High-Dose Vitamin K2 (90-mcg/d) | Active Comparator | The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo-Control | Dietary Supplement | two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum lipid concentrations | To determine if the vitamin K-induced change in matrix Gla protein carboxylation improves fasting lipid panel (triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol) in a dose-dependent manner. | 8 weeks |
| Change in insulin sensitivity | To determine if the vitamin K-induced change in osteocalcin carboxylation effects insulin sensitivity in a dose-dependent manner. Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a two-hour oral glucose tolerance test by using the oral glucose minimal model. | 8 weeks |
| Change in beta-cell function | To determine if the vitamin K-induced change in osteocalcin carboxylation effects beta-cell function 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 two-hour oral glucose tolerance test by using the oral C-peptide minimal model. | 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Change in arterial stiffness (pulse wave velocity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman K Pollock, PhD | Department of Pediatrics, Medical College of Georgia, Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Georgia; Augusta University | Augusta | Georgia | 30912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28794209 | Background | Douthit MK, Fain ME, Nguyen JT, Williams CF, Jasti AH, Gutin B, Pollock NK. Phylloquinone Intake Is Associated with Cardiac Structure and Function in Adolescents. J Nutr. 2017 Oct 1;147(10):1960-1967. doi: 10.3945/jn.117.253666. |
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| Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d) | Dietary Supplement | one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks |
|
|
| High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d) | Dietary Supplement | two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks |
|
|
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. |
| 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. | 8 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
| D006943 | Hyperglycemia |
| D002318 | Cardiovascular Diseases |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| C062629 | menaquinone 7 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
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