Arteriosclerosis, Bone Loss
Conditions
Keywords
vitamin K2, menaquinone-7, bone health, vascular health
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTmenaquinone-7
180 µg menaquinone-7 daily for three years
DIETARY_SUPPLEMENTplacebo
1 placebo capsule daily for three years
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density, bone mineral content and bone geometry measured by DEXA. Vascular elasticity, intima-media thickness and pulse wave velocity measured by ultrasound | three years |
Secondary
| Measure | Time frame |
|---|---|
| The vitamin K-dependent proteins: uncarboxylated osteocalcin (ucOC), carboxylated osteocalcin (cOC), uncarboxylated matrix-Gla protein (ucMGP) and carboxylated matrix-Gla protein cMGP) | three years |
Countries
Netherlands
Outcome results
None listed