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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02366481
Other study ID # 620511
Secondary ID 16GRNT31090037
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date June 30, 2020

Study information

Verified date November 2019
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date June 30, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Healthy adults between 18 and 65 years old

2. Subject understands the study protocol and agrees to comply with it

3. Informed Consent Form signed by the subject

Exclusion Criteria:

1. Subjects using vitamin supplements containing vitamin k

2. Subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders

3. Subjects presenting chronic degenerative and/or inflammatory diseases

4. Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)

5. Subjects receiving corticosteroid treatment

6. Subjects using oral anticoagulants

7. Subjects with a history of soy allergy

8. Subjects who have participated in a clinical study more recently than one month before the current study

Study Design


Intervention

Dietary Supplement:
Placebo
Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.
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.
High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)
Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks.

Locations

Country Name City State
United States Medical College of Georgia; Augusta University Augusta Georgia

Sponsors (4)

Lead Sponsor Collaborator
Augusta University Tufts University, University of Alabama at Birmingham, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Booth SL, Centi A, Smith SR, Gundberg C. The role of osteocalcin in human glucose metabolism: marker or mediator? Nat Rev Endocrinol. 2013 Jan;9(1):43-55. doi: 10.1038/nrendo.2012.201. Epub 2012 Nov 13. Review. — View Citation

Gower BA, Pollock NK, Casazza K, Clemens TL, Goree LL, Granger WM. Associations of total and undercarboxylated osteocalcin with peripheral and hepatic insulin sensitivity and ß-cell function in overweight adults. J Clin Endocrinol Metab. 2013 Jul;98(7):E1173-80. doi: 10.1210/jc.2013-1203. Epub 2013 Apr 24. Erratum in: J Clin Endocrinol Metab. 2016 May;101(5):2265. — View Citation

Pollock NK, Bernard PJ, Gower BA, Gundberg CM, Wenger K, Misra S, Bassali RW, Davis CL. Lower uncarboxylated osteocalcin concentrations in children with prediabetes is associated with beta-cell function. J Clin Endocrinol Metab. 2011 Jul;96(7):E1092-9. doi: 10.1210/jc.2010-2731. Epub 2011 Apr 20. — View Citation

Pollock NK. Childhood obesity, bone development, and cardiometabolic risk factors. Mol Cell Endocrinol. 2015 Jul 15;410:52-63. doi: 10.1016/j.mce.2015.03.016. Epub 2015 Mar 27. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in insulin sensitivity Insulin sensitivity will be calculated from plasma insulin and glucose concentrations measured during a 2-hour oral glucose tolerance test by using the oral glucose minimal model. Change from baseline in insulin sensitivity at 8 weeks
Primary Change in beta-cell function 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 oral glucose tolerance test by using the oral C-peptide minimal model. Change from baseline in beta-cell function at 8 weeks
Secondary Change in prothrombin time (PT) Change from baseline in PT at 8 weeks
Secondary Change in activated partial thromboplastin time (aPTT) Change from baseline in aPTT at 8 weeks
Secondary Change in arterial stiffness (PWV) Arterial stiffness will be assessed using carotid-femoral pulse wave velocity (PWV) by applanation tonometry. Change from baseline in arterial stiffness at 8 weeks
Secondary Change in endothelial function (FMD) Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD) by ultrasound. Change from baseline in endothelial function at 8 weeks
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