Arabic Gum-Absorption Study

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858767
• Other study ID #: 08-3-064
• Status: Completed
• Phase: N/A
• First received: March 9, 2009
• Last updated: December 15, 2010
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: December 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• menaquinone-7 from casein capsules
90 µg menaquinone-7 daily during 8 weeks
• menaquinone-7 from arabic gum capsules
90 µg menaquinone-7 daily during 8 weeks
• menaquinone-7 from linseed oil capsules
90 µg menaquinone-7 daily during 8 weeks

Locations

Country	Name	City	State
Netherlands	VitaK BV /University of Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level menaquinone-7		8 weeks	No
Secondary	plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin		8 weeks	No