Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Obesity, Insulin Resistance, Insulin Sensitivity, Beta-Cell Dysfunction, Prediabetes
In brief
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.
Key facts
- Study ID
- NCT02366481
- Run by
- Augusta University
- People needed
- 30
- Starts
- 2015-02-01
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2019-11-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults between 18 and 65 years old
- Subject understands the study protocol and agrees to comply with it
- Informed Consent Form signed by the subject
You may not qualify if…
- 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
Where it is running
- Medical College of Georgia; Augusta University — Augusta, Georgia, United States
Full record on ClinicalTrials.gov
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