Arabic Gum-Absorption Study

NCT00858767 | Completed

• 1 other identifier: 08-3-064
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability

Keywords

vitamin K2; absorption; efficacy

Outcome Measures

Primary Outcomes (1)

• serum level menaquinone-7

  8 weeks

Secondary Outcomes (1)

• plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin

  8 weeks

Study Arms (3)

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

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

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

Interventions

menaquinone-7 from casein capsules DIETARY_SUPPLEMENT

90 µg menaquinone-7 daily during 8 weeks

1

menaquinone-7 from arabic gum capsules DIETARY_SUPPLEMENT

90 µg menaquinone-7 daily during 8 weeks

2

menaquinone-7 from linseed oil capsules DIETARY_SUPPLEMENT

90 µg menaquinone-7 daily during 8 weeks

3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

VitaK BV /University of Maastricht

Maastricht, PO Box 616, Netherlands

Location

Study Officials

• Cees Vermeer, PhD

  VitaK /University of Maastricht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 16, 2010

Record last verified: 2010-12

Locations

NL (1)