Beneficial Effects of Long Term Menaquinone-7

Maastricht University Medical Center240 enrolled

Overview

From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and matrix-Gla protein (in the arterial vessel wall). The question remains whether supplementation with MK-7 also leads to measurable improvements of bone and vascular health. The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of an MK-7- supplement will be monitored during three years on bone quantity and quality and on vascular characteristics and function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Bone Loss Arteriosclerosis

Interventions

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy postmenopausal women between 55 and 65 years old * Subjects of normal body weight and height according to BMI \< 30 * Subjects of Caucasian race * Subject has given written consent to take part in the study Exclusion Criteria: * Subjects with (a history of) metabolic or gastrointestinal disease * Subjects presenting chronic degenerative and/or inflammatory disease * Subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters * Subjects receiving corticoϊd treatment * Subjects using oral anticoagulants * Subject using bisphosphonates * Subjects using hormone replacement therapy * Subjects undergoing ovariectomy and/or hysterectomy * Subject with (a history of) soy allergy * Subjects using vitamin K containing multivitamins or vitamin K supplements * Subjects who have participated in a clinical study more recently than one month before the current study * Subjects who are found to be osteoporotic at baseline (T-score \< -2.5)

Outcomes

Primary Outcomes

Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound

Time frame: three years

Secondary Outcomes

The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP)