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Arabic Gum-Absorption Study

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Bioavailability

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00858767
08-3-064

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

69 participants in 3 patient groups

1
Active Comparator group
Description:
2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks
Treatment:
Dietary Supplement: menaquinone-7 from casein capsules
2
Active Comparator group
Description:
2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks
Treatment:
Dietary Supplement: menaquinone-7 from arabic gum capsules
3
Active Comparator group
Description:
2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks
Treatment:
Dietary Supplement: menaquinone-7 from linseed oil capsules

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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