NCT01638143 - Bio-equivalence Study | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

24

Conditions

Bioequivalence Bioavailability

Interventions

MenaQ7 M-1500 capsulesDIETARY_SUPPLEMENT

The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): * MenaQ7 M-1500 capsule * Gnosis P-1000 capsule * Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Gnosis P-1000 capsulesDIETARY_SUPPLEMENT

The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): * MenaQ7 M-1500 capsule * Gnosis P-1000 capsule * Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Gnosis M-1500 capsulesDIETARY_SUPPLEMENT

The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day): * MenaQ7 M-1500 capsule * Gnosis P-1000 capsule * Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

VitaK BV / Maastricht University Medical Center

Maastricht, Netherlands

Outcomes

Primary Outcomes

MK-7 absorption profiles

The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.

Time frame: 9 weeks