Vitamin K to Slow Progression of Dyslipidemia and Diabetes Risk (Vita-K 'n' Kids Study II)

Not Applicable

• Conditions: Obesity; Obesity in Diabetes; Hyperlipidemia; Hyperglycemia; Insulin Resistance; Nutritional and Metabolic Diseases; Cardiovascular Diseases
• Interventions: Dietary Supplement: Placebo-Control; Dietary Supplement: Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d); Dietary Supplement: High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)

• Registration Number: NCT02959762
• Lead Sponsor: Augusta University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 8 to 17 years
• Body mass index equal to or greater than 85th percentile for age and sex
• Subject and parent/guardian understands the study protocol and agrees to comply with it
• Informed Consent Form signed by the parent/guardian and assent signed by the subject

Exclusion Criteria

• Subjects using vitamin supplements containing vitamin k
• Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders
• Subjects presenting chronic degenerative and/or inflammatory diseases
• Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
• Subjects receiving corticosteroid treatment
• Subjects using oral anticoagulants
• Subjects with a history of soy allergy
• Subjects who have participated in a clinical study more recently than one month before the current study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-Control	Placebo-Control	The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
Low-Dose Vitamin K2 (45-mcg/d)	Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)	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)	High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)	The high-dose vitamin K2 group will take two 45-mcg vitamin K2 softgel capsules every day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity	8 weeks	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.
Change in serum lipid concentrations	8 weeks	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.
Change in beta-cell function	8-weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in endothelial function (flow-mediated dilation)	8 weeks	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.
Change in arterial stiffness (pulse wave velocity)	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.
Change in coagulation	8 weeks	Coagulation-related parameters (i.e., prothrombin time and activated partial thromboplastin time) will be assessed at baseline and 8 weeks to assess clotting function.

Trial Locations

Locations (1)

Medical College of Georgia; Augusta University; 🇺🇸 Augusta, Georgia, United States