Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes (Vita-K 'n' Adults Study)
NCT ID: NCT02366481
Last Updated: 2019-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-02-28
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo-Control
The placebo-control group will take two placebo softgel capsules every day for 8 weeks.
Placebo
Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.
Low-Dose Vitamin K2 (90-mcg/d)
The low-dose vitamin K group will take one 90-mcg vitamin K2 (menaquinone-7) softgel capsule and one placebo softgel capsule 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 (180-mcg/d)
The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Subject understands the study protocol and agrees to comply with it
3. Informed Consent Form signed by the subject
Exclusion Criteria
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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Yale University
OTHER
Tufts University
OTHER
Augusta University
OTHER
Responsible Party
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Norman Pollock
Associate Professor, Department of Medicine
Principal Investigators
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Norman K Pollock, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Medical College of Georgia, Augusta University
Locations
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Medical College of Georgia; Augusta University
Augusta, Georgia, United States
Countries
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References
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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.
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 beta-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.
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.
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.
Other Identifiers
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16GRNT31090037
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
620511
Identifier Type: -
Identifier Source: org_study_id
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