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

Primary Purpose

Obesity, Insulin Resistance, Insulin Sensitivity

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Placebo

Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)

High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)

About this trial

This is an interventional prevention trial for Obesity focused on measuring Vitamin K, Vitamin K2, Menaquinone-7, Osteocalcin, Adults, Obesity, Insulin resistance, Insulin sensitivity, Beta-cell function, Prediabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

Medical College of Georgia; Augusta University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo-Control

Low-Dose Vitamin K2 (90-mcg/d)

High-Dose Vitamin K2 (180-mcg/d)

Arm Description

The placebo-control group will take two placebo softgel capsules every day for 8 weeks.

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.

The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day for 8 weeks.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

Change in prothrombin time (PT)

Change in activated partial thromboplastin time (aPTT)

Change in arterial stiffness (PWV)

Arterial stiffness will be assessed using carotid-femoral pulse wave velocity (PWV) by applanation tonometry.

Change in endothelial function (FMD)

Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD) by ultrasound.

Full Information

NCT ID

NCT02366481

First Posted

February 12, 2015

Last Updated

November 18, 2019

Sponsor

Augusta University

Collaborators

University of Alabama at Birmingham, Yale University, Tufts University

1. Study Identification

Unique Protocol Identification Number

NCT02366481

Brief Title

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

Official Title

Vitamin K and Glucose Metabolism in Adults at Risk for Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 1, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Augusta University

Collaborators

University of Alabama at Birmingham, Yale University, Tufts University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Vitamin K, Vitamin K2, Menaquinone-7, Osteocalcin, Adults, Obesity, Insulin resistance, Insulin sensitivity, Beta-cell function, Prediabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo-Control

Arm Type

Placebo Comparator

Arm Description

The placebo-control group will take two placebo softgel capsules every day for 8 weeks.

Arm Title

Low-Dose Vitamin K2 (90-mcg/d)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

High-Dose Vitamin K2 (180-mcg/d)

Arm Type

Active Comparator

Arm Description

The high-dose vitamin K group will take two 90-mcg vitamin K2 (menaquinone-7) softgel capsules every day for 8 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)

Intervention Description

One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)

Intervention Description

Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks.

Primary Outcome Measure Information:

Title

Change in insulin sensitivity

Description

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.

Time Frame

Change from baseline in insulin sensitivity at 8 weeks

Title

Change in beta-cell function

Description

Time Frame

Change from baseline in beta-cell function at 8 weeks

Secondary Outcome Measure Information:

Title

Change in prothrombin time (PT)

Time Frame

Change from baseline in PT at 8 weeks

Title

Change in activated partial thromboplastin time (aPTT)

Time Frame

Change from baseline in aPTT at 8 weeks

Title

Change in arterial stiffness (PWV)

Description

Arterial stiffness will be assessed using carotid-femoral pulse wave velocity (PWV) by applanation tonometry.

Time Frame

Change from baseline in arterial stiffness at 8 weeks

Title

Change in endothelial function (FMD)

Description

Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD) by ultrasound.

Time Frame

Change from baseline in endothelial function at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norman K Pollock, Ph.D.

Organizational Affiliation

Department of Pediatrics, Medical College of Georgia, Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical College of Georgia; Augusta University

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21508147

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.

Results Reference

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PubMed Identifier

23616149

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 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. Erratum In: J Clin Endocrinol Metab. 2016 May;101(5):2265.

Results Reference

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PubMed Identifier

23147574

Citation

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.

Results Reference

background

PubMed Identifier

25817542

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.

Results Reference

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

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