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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00858767
Enrollment
69
Registered
2009-03-10
Start date
2008-10-31
Completion date
2009-08-31
Last updated
2010-12-16

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

Conditions

Bioavailability

Keywords

vitamin K2, absorption, efficacy

Brief 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.

Interventions

DIETARY_SUPPLEMENTmenaquinone-7 from casein capsules

90 µg menaquinone-7 daily during 8 weeks

DIETARY_SUPPLEMENTmenaquinone-7 from arabic gum capsules

90 µg menaquinone-7 daily during 8 weeks

DIETARY_SUPPLEMENTmenaquinone-7 from linseed oil capsules

90 µg menaquinone-7 daily during 8 weeks

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
serum level menaquinone-78 weeks

Secondary

MeasureTime frame
plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin8 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026