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

Augusta University

Status: Unknown

Conditions: Prediabetes; Beta-Cell Dysfunction; Insulin Resistance; Obesity; Insulin Sensitivity

Treatments: Dietary Supplement: Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d); Dietary Supplement: Placebo; Dietary Supplement: High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)

Study type: Interventional

Funder types: Other

Identifiers

NCT02366481

620511

16GRNT31090037 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Placebo-Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

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

Active Comparator group

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.

Treatment:

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

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

Active Comparator group

Description:

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

Treatment:

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