Arabic Gum-Absorption Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Bioavailability

Intervention / Treatment
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* Dietary Supplement: menaquinone-7 from casein capsules
* Dietary Supplement: menaquinone-7 from arabic gum capsules
* Dietary Supplement: menaquinone-7 from linseed oil capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks | Dietary Supplement: menaquinone-7 from casein capsules<br>* 90 µg menaquinone-7 daily during 8 weeks<br>|
| Active Comparator: 2<br>2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks | Dietary Supplement: menaquinone-7 from arabic gum capsules<br>* 90 µg menaquinone-7 daily during 8 weeks<br>|
| Active Comparator: 3<br>2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks | Dietary Supplement: menaquinone-7 from linseed oil capsules<br>* 90 µg menaquinone-7 daily during 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level menaquinone-7 |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin K2, absorption, efficacy