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Arabic Gum-Absorption Study

NCT00858767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2010-12-16

No results posted yet for this study

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

  • Bioavailability

Interventions

DIETARY_SUPPLEMENT

menaquinone-7 from casein capsules

90 µg menaquinone-7 daily during 8 weeks

DIETARY_SUPPLEMENT

menaquinone-7 from arabic gum capsules

90 µg menaquinone-7 daily during 8 weeks

DIETARY_SUPPLEMENT

menaquinone-7 from linseed oil capsules

90 µg menaquinone-7 daily during 8 weeks

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Cees Vermeer, PhD · VitaK /University of Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858767 on ClinicalTrials.gov