Arabic Gum-Absorption Study

December 15, 2010 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, PO Box 616
        • VitaK BV /University of Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks
Dietary supplement: menaquinone-7 from casein capsules
90 µg menaquinone-7 daily during 8 weeks
Active Comparator: 2
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
90 µg menaquinone-7 daily during 8 weeks
Active Comparator: 3
2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks
Dietary supplement: menaquinone-7 from linseed oil capsules
90 µg menaquinone-7 daily during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum level menaquinone-7
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Cees Vermeer, PhD, VitaK /University of Maastricht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Estimate)

December 16, 2010

Last Update Submitted That Met QC Criteria

December 15, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-3-064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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