NCT02366481

Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)

Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Given that glutamate carboxylation or decarboxylation is key to the metabolic role of osteocalcin (at least in mouse models) and that carboxylation is vitamin K dependent, it is critical to isolate the effect of vitamin K manipulation on carboxylation of osteocalcin and its subsequent effect on glucose metabolism in clinical trials. The purpose of this randomized, double-blind, placebo-controlled clinical trial in adults is to determine whether eight weeks of daily supplementation with vitamin K2 (menaquinone-7) can improve markers in blood associated with diabetes risk.

Conditions

• Obesity
• Insulin Resistance
• Insulin Sensitivity
• Beta-Cell Dysfunction
• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.
DIETARY_SUPPLEMENT	Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)	One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks.
DIETARY_SUPPLEMENT	High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)	Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks.

Timeline

• Start date: 2015-02-01
• Primary completion: 2020-06-01
• Completion: 2020-06-30
• First posted: 2015-02-19
• Last updated: 2019-11-20

Locations

1 site across 1 country: United States