Bio-equivalence Study

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Bioequivalence; Bioavailability

Treatments: Dietary Supplement: MenaQ7 M-1500 capsules; Dietary Supplement: Gnosis P-1000 capsules; Dietary Supplement: Gnosis M-1500 capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT01638143

10-3-017

Details and patient eligibility

About

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

Full description

Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.

Enrollment: 24 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women, aged between 20 and 40 years
• Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)
• Stable body weight (weight gain or loss < 3 kg in past 3 mo)
• Written consent to take part in the study
• Agreement to adhere to dietary restrictions required by the protocol

Exclusion criteria

• Abuse of drugs and/or alcohol
• Use of vitamin supplements containing vitamin K
• Soy allergy
• Pregnancy
• a history of) metabolic or gastrointestinal diseases including hepatic disorders
• Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure
• Use of oral anticoagulants
• Corticoid treatment
• Subjects with anaemia or subjects who recently donated blood or plasma
• Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Gnosis P-1000 capsules

Active Comparator group

Description:

MK-7 capsules containing 75 µg of MK-7 (source: Gnosis, Italy).

Treatment:

Dietary Supplement: Gnosis P-1000 capsules

Gnosis M1500 capsules

Active Comparator group

Description:

MK-7 capsules containing 75 µg of MK-7 (source Gnosis, Italy).

Treatment:

Dietary Supplement: Gnosis M-1500 capsules

MenaQ7 M-1500 capsules

Active Comparator group

Description:

MK-7 capsules containing 75 µg of MK-7 (source: Nattopharma, Norway)

Treatment:

Dietary Supplement: MenaQ7 M-1500 capsules

Dietary Supplement: Gnosis P-1000 capsules