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Arabic Gum-Absorption Study

NCT ID: NCT00858767

Last Updated: 2010-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

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.

Detailed Description

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Conditions

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Bioavailability

Keywords

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vitamin K2 absorption efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

menaquinone-7 from casein capsules

Intervention Type DIETARY_SUPPLEMENT

90 µg menaquinone-7 daily during 8 weeks

2

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

Group Type ACTIVE_COMPARATOR

menaquinone-7 from arabic gum capsules

Intervention Type DIETARY_SUPPLEMENT

90 µg menaquinone-7 daily during 8 weeks

3

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

Group Type ACTIVE_COMPARATOR

menaquinone-7 from linseed oil capsules

Intervention Type DIETARY_SUPPLEMENT

90 µg menaquinone-7 daily during 8 weeks

Interventions

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menaquinone-7 from casein capsules

90 µg menaquinone-7 daily during 8 weeks

Intervention Type DIETARY_SUPPLEMENT

menaquinone-7 from arabic gum capsules

90 µg menaquinone-7 daily during 8 weeks

Intervention Type DIETARY_SUPPLEMENT

menaquinone-7 from linseed oil capsules

90 µg menaquinone-7 daily during 8 weeks

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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VitaK BV

Principal Investigators

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Cees Vermeer, PhD

Role: PRINCIPAL_INVESTIGATOR

VitaK /University of Maastricht

Locations

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VitaK BV /University of Maastricht

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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08-3-064

Identifier Type: -

Identifier Source: org_study_id