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Comparative study of three delivery systems of menaquinone-7

Comparative study of three delivery systems of menaquinone-7 - Comparative study menaquinone-7

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37333
Enrollment
114
Registered
2012-03-28
Start date
2012-04-16
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preventie van hart-en vaatziekten vitamin K deficiency vitamin K insufficiency

Interventions

During the 6-wk intervention period, the subjects will be instructed to report any signs of illness, medication used, and any deviations from the study protocol. Subjects will be urged not to change
therefore body weight will be measured at the first and last study visit. In addition, two weeks (14 days) before the start of the study until the final blood sampling, participants will be asked t

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Apparently healthy men and postmenopausal women between 45 and 65 years old Subjects with body weight and height according to BMI between 23 and 30 kg/m2 Subject has given written consent to take part in the study Subjects of Caucasian race

Exclusion criteria

Exclusion criteria: Subjects with hypertension Subjects with hypercholesterolemia Subjects with (a history of) metabolic or gastrointestinal disease Subjects presenting chronic degenerative and/or inflammatory disease Subjects with (a history) of diabetes mellitus Abuse of drugs and/or alcohol Subjects receiving corticosteroid treatment Subjects using oral anticoagulants and subjects with clotting disorders Subjects using blood pressure-lowering medication Subjects using cholesterol-lowering medication Subjects using multivitamins or vitamin K supplements Subjects consuming high amounts of vitamin K-containing food products Subjects with cow*s milk allergy and lactose intolerance

Design outcomes

Secondary

MeasureTime frame
The biochemical markers carboxylated MGP (cMGP), desphospho-uncarboxylated MGP (dp-ucMGP), carboxylated osteocalcin (cOC) and uncarboxylated osteocalcin (ucOC), will be measured at the various time-points (t = 0, 4, 6, 7 and 8 weeks) to determine the efficacy of the nutrient-enriched product vs. the other 2 products on MGP carboxylation status in the vessel wall and OC carboxylation.

Primary

MeasureTime frame
The circulating MK-7 levels will be measured at the various time-points (t = 0, 2, 4, 6 weeks) during intervention and the wash-out period (t= 3 days, 1 and 2 weeks) to determine the absorption profile of MK-7 within the dairy product.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)