Healthy
Conditions
Keywords
absorption, encapsulation, menaquinone, Bio-availability
Brief summary
From previous studies it appeared 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. However, the taste of natto is not appreciated by the western society. For this reason the active biological compound is produced as a capsule. Different techniques of encapsulation the vitamin can lead to different absorption profiles with intake. Therefore it is important to study influence of type of encapsulation technique on absorption of menaquinone-7. This study is undertaken to compare absorption of menaquinones between two different encapsulation techniques. Absorption profiles of menaquinone-4 and menaquinone-7 of conventional softgel capsules and newly developed GellpelTM capsules are compared between each other.
Interventions
DIETARY_SUPPLEMENTVitamin K2 in softgel
4 softgel capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 softgel capsules containing 30 µg MK-4 per capsule
DIETARY_SUPPLEMENTVitamin K2 in Gelpell
4 Gelpell capsules containing 45 µg MK-7 and 5 µg vitamin D3 per capsule and 4 Gelpell capsules containing 30 µg MK-4 per capsule
Sponsors
VitaK
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women between 20 and 30 years old * Subjects of normal body weight and height according to BMI \< 30 * Subjects of Caucasian race * Subject has given written consent to take part in the study
Exclusion criteria
* Subjects with (a history of) metabolic or gastrointestinal disease * Subjects presenting chronic degenerative and/or inflammatory disease * Subjects receiving corticoϊd treatment * Subjects using oral anticoagulants * Subject with (a history of) soy allergy * Subjects using vitamin K containing multivitamins or vitamin K supplements * Subjects with anaemia or subjects who recently donate blood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean difference in plasma concentration of MK-4 and MK-7 between the two types of capsules (softgel or gelpell)concerns the primary outcome measure. | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The mean difference in serum concentration of vitamin D3 between the two types of capsules (softgel or gelpell) concerns the secondary endpoint for this study. | 4 weeks |
Countries
Netherlands
Outcome results
None listed