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Completed

NCT Number: NCT00858767

Arabic Gum-Absorption Study

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.

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Key information

Conditions

Bioavailability

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VitaK BV /University of Maastricht

Maastricht, PO Box 616, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

menaquinone-7 from casein capsules

Dietary Supplement

90 µg menaquinone-7 daily during 8 weeks

menaquinone-7 from arabic gum capsules

Dietary Supplement

90 µg menaquinone-7 daily during 8 weeks

menaquinone-7 from linseed oil capsules

Dietary Supplement

90 µg menaquinone-7 daily during 8 weeks

Primary outcomes

  1. serum level menaquinone-7

    Time frame: 8 weeks

Secondary outcomes

  1. plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2009
Registry last updated
Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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