Arabic Gum-Absorption Study

Not Applicable

Completed

• Conditions: Bioavailability
• Interventions: Dietary Supplement: menaquinone-7 from arabic gum capsules; Dietary Supplement: menaquinone-7 from casein capsules; Dietary Supplement: menaquinone-7 from linseed oil capsules

• Registration Number: NCT00858767
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2009-05
• Study Completion: 2009-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-15
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	menaquinone-7 from arabic gum capsules	2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks
1	menaquinone-7 from casein capsules	2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks
3	menaquinone-7 from linseed oil capsules	2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks

Primary Outcome Measures

Name	Time	Method
serum level menaquinone-7	8 weeks

Secondary Outcome Measures

Name	Time	Method
plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin	8 weeks

Trial Locations

Locations (1)

VitaK BV /University of Maastricht; 🇳🇱 Maastricht, Netherlands