Arabic Gum-Absorption Study

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Bioavailability

Treatments: Dietary Supplement: menaquinone-7 from linseed oil capsules; Dietary Supplement: menaquinone-7 from arabic gum capsules; Dietary Supplement: menaquinone-7 from casein capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT00858767

08-3-064

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 3 patient groups

1

Active Comparator group

Description:

2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks

Treatment:

Dietary Supplement: menaquinone-7 from casein capsules

2

Active Comparator group

Description:

2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks

Treatment:

Dietary Supplement: menaquinone-7 from arabic gum capsules

3

Active Comparator group

Description:

2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks

Treatment:

Dietary Supplement: menaquinone-7 from linseed oil capsules