Comparative Study Menaquinone-7

NCT01873274 | Completed

• 1 other identifier: 12-3-009
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (1)

• The change in plasma MK-7 concentration after intervention between the three study groups

  baseline and 6 weeks

Secondary Outcomes (1)

• The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.

  baseline and 6 weeks

Other Outcomes (1)

• The change in circulating vitamin D (25-hydroxy-vitamin D) after intervention between the study groups.

  baseline and 6 weeks

Study Arms (3)

basic yogurt enriched with MK-7

ACTIVE COMPARATOR

one study group will receive daily two basic dairy products enriched with MK-7 (50 μg)

Dietary Supplement: basic yogurt enriched with MK-7

MK-7 containing capsule

ACTIVE COMPARATOR

one study group will receive daily a softgel capsule consisting of 50 μg MK-7

Dietary Supplement: MK-7 containing capsule

nutrient enriched yogurt with MK-7

ACTIVE COMPARATOR

one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil)

Dietary Supplement: nutrient-enriched yogurt with MK-7

Interventions

MK-7 containing capsule DIETARY_SUPPLEMENT

MK-7 containing capsule

basic yogurt enriched with MK-7 DIETARY_SUPPLEMENT

basic yogurt enriched with MK-7

nutrient-enriched yogurt with MK-7 DIETARY_SUPPLEMENT

nutrient enriched yogurt with MK-7

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Apparently healthy men and postmenopausal women between 45 and 65 years old
• Subjects with body weight and height according to BMI between 20 and 30 kg/m2
• Subjects of Caucasian race
• Subject has given written consent to take part in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

VitaK BV / Maastricht University Medical Center

Maastricht, 6229 EV, Netherlands

Location

Study Officials

• Cees Vermeer, PhD

  VitaK BV Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 10, 2013
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: May 1, 2013
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

NL (1)