Clinical Trials Directory

Trials / Completed

CompletedNCT00858767

Arabic Gum-Absorption Study

Comparison of Absorption and Efficacy of 3 Different Menaquinone-7 Delivery Systems; Casein Powder, Arabic Gum Powder, or Linseed Oil

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
69 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
20 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTmenaquinone-7 from casein capsules90 µg menaquinone-7 daily during 8 weeks
DIETARY_SUPPLEMENTmenaquinone-7 from arabic gum capsules90 µg menaquinone-7 daily during 8 weeks
DIETARY_SUPPLEMENTmenaquinone-7 from linseed oil capsules90 µg menaquinone-7 daily during 8 weeks

Timeline

Start date
2008-10-01
Primary completion
2009-05-01
Completion
2009-08-01
First posted
2009-03-10
Last updated
2010-12-16

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00858767. Inclusion in this directory is not an endorsement.