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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00858767
Other study ID # 08-3-064
Secondary ID
Status Completed
Phase N/A
First received March 9, 2009
Last updated December 15, 2010
Start date October 2008
Est. completion date August 2009

Study information

Verified date December 2010
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society. For this reason, the active biological compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy affecting a minimum of 2-3% of infants. The investigators will therefore compare this protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides). To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators will also test the efficacy of enriched linseed oil.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date August 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy men and women aged between 20 and 40 y

- Normal body weight and height (BMI <30 kg/m2)

- Stable body weight (weight gain or loss <3 kg in past 3 mo)

- Caucasian race

- Written consent to take part in the study

- Low vitamin K status

Exclusion Criteria:

- (A history of) metabolic or gastrointestinal diseases

- Chronic degenerative and/or inflammatory diseases

- Abuse of drugs and/or alcohol

- Use of corticosteroids

- Use of oral anticoagulants

- (A history of) soy allergy

- Use of vitamin K-containing multivitamins or vitamin K supplements

- Anaemia

- Blood donation or participation in another study within one month before the study

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
menaquinone-7 from casein capsules
90 µg menaquinone-7 daily during 8 weeks
menaquinone-7 from arabic gum capsules
90 µg menaquinone-7 daily during 8 weeks
menaquinone-7 from linseed oil capsules
90 µg menaquinone-7 daily during 8 weeks

Locations

Country Name City State
Netherlands VitaK BV /University of Maastricht Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum level menaquinone-7 8 weeks No
Secondary plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin 8 weeks No
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