Biocomparison Study

Maastricht University Medical Center81 enrolled

Overview

The effects of two vitamin K-forms on carboxylation of the vitamin K-dependent proteins osteocalcin and matrix-gla protein will be compared after supplementing these vitamins in a nutritional dose range. The investigators hypothesized that MK-7 is more effective than K1 at a dose comparable to the RDA of vitamin K.

Vitamin K is a group name for the naturally occurring phylloquinone (K1) and menaquinones (MK-n; K2). The latter can be subdivided into the short-chain (e.g. MK-4) and the long-chain (e.g. MK-7, MK-8, and MK-9) menaquinones. Earlier studies have shown that high vitamin K intake leads to improved bone and vascular health by increased carboxylation of vitamin K-dependent proteins in these tissues. In the dietary range, MK-7 has been suggested to be the most effective cofactor for the carboxylation of Gla-proteins, such as osteocalcin (OC) and matrix-Gla protein (MGP).Until now, no randomized controlled trial has compared the efficacy of K1 versus MK-7 in a nutritional dose range. The investigators are therefore interested to compare the effects of K1 and MK-7 on OC and MGP carboxylation after supplementing these vitamins at a dose not exceeding the RDA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bone Health Vascular Health

Interventions

PlaceboDIETARY_SUPPLEMENT

27 participants received for three months 1 placebo capsule per day

Vitamin K1-capsulesDIETARY_SUPPLEMENT

27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day

Vitamin K2-capsulesDIETARY_SUPPLEMENT

27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women, aged between 20-80 years * Normal body weight and height (18.5 kg/m2 \< BMI \< 30 kg/m2) * Stable body weight (weight gain or loss \< 3 kg in past 3 mo) * Written consent to take part in the study * Agreement to adhere to dietary restrictions required by the protocol Exclusion Criteria: * Abuse of drugs and/or alcohol * Use of vitamin supplements containing vitamin K * Pregnancy * (a history of) metabolic or gastrointestinal diseases, e.g. hepatic or renal disorders, osteoporosis * Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, cancer, cardiovascular disease * Use of oral anticoagulants, drugs or hormones that influence bone metabolism * Corticoid treatment * Subjects with anaemia or subjects who recently donated blood or plasma * Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Locations (1)

VitaK BV / Maastricht University Medicial Center

Maastricht, Netherlands

Outcomes

Primary Outcomes

carboxylation of osteocalcin

The primary objective of the study is to compare the effects of K1 and MK-7 on circulating ucOC levels after supplementing these vitamins at a nutritional dose.

Time frame: 12 weeks

Secondary Outcomes

carboxylation of matrix-gla protein

The secondary objective of the study is to compare the effects of K1 and MK-7 on circulating ucMGP, which is emerging as a biomarker of arterial calcification.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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