Arabic Gum-Absorption Study - Full Text View

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00858767

Purpose

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.

Condition	Intervention
Bioavailability	Dietary Supplement: menaquinone-7 from casein capsules Dietary Supplement: menaquinone-7 from arabic gum capsules Dietary Supplement: menaquinone-7 from linseed oil capsules

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Vitamin K Menaquinone 7 Linseed oil Casein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Bio-availability Study
Official Title:	Comparison of Absorption and Efficacy of 3 Different Menaquinone-7 Delivery Systems; Casein Powder, Arabic Gum Powder, or Linseed Oil

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

serum level menaquinone-7 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	69
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator 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

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858767

Locations

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

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator:

Cees Vermeer, PhD

VitaK /University of Maastricht

More Information

No publications provided

Responsible Party:	VitaK BV ( Dr. C. Vermeer )
Study ID Numbers:	08-3-064
Study First Received:	March 9, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00858767 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

vitamin K2
absorption
efficacy

Study placed in the following topic categories:

Fibrin Modulating Agents
Antiplasmin
Caseins
Antifibrinolytic Agents
Vitamin MK 7
Vitamins

Vitamin K
Trace Elements
Micronutrients
Vitamin K 2
Hemostatics

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vitamin MK 7
Coagulants
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Vitamin K 2
Hemostatics

Pharmacologic Actions
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Vitamins
Vitamin K
Micronutrients

ClinicalTrials.gov processed this record on May 06, 2009