BioavailabilityNCT01873274
Comparative Study Menaquinone-7
A study testing MK-7 containing capsule, basic yogurt enriched with MK-7 and nutrient-enriched yogurt with MK-7 in people with Bioavailability, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- MK-7 containing capsule, basic yogurt enriched with MK-7 and nutrient-enriched yogurt with MK-7
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy men and postmenopausal women between 45 and 65 years old
- Subjects with body weight and height according to BMI between 20 and 30 kg/m2
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
Who cannot join
- Subjects with hypertension
- Subjects with hypercholesterolemia
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects with (a history) of diabetes mellitus
- Abuse of drugs and/or alcohol
Show all 13Show fewer
- Subjects receiving corticosteroid treatment
- Subjects using oral anticoagulants and subjects with clotting disorders
- Subjects using blood pressure-lowering medication
- Subjects using cholesterol-lowering medication
- Subjects using multivitamins or vitamin K supplements
- Subjects consuming high amounts of vitamin K-containing food products
- Subjects with cow's milk allergy and lactose intolerance
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VitaK BV / Maastricht University Medical Center
Maastricht, 6229 EV
About this study
Official title: Comparative Study of Three Delivery Systems of Menaquinone-7
The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.
Read the detailed description
In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.
- Conditions
- Bioavailability
- Being tested
- MK-7 containing capsule, basic yogurt enriched with MK-7, nutrient-enriched yogurt with MK-7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7 containing capsuleDietary supplement
basic yogurt enriched with MK-7Dietary supplement
nutrient-enriched yogurt with MK-7Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| basic yogurt enriched with MK-7 | Active comparator | one study group will receive daily two basic dairy products enriched with MK-7 (50 μg) Receives: Dietary Supplement: basic yogurt enriched with MK-7 |
| MK-7 containing capsule | Active comparator | one study group will receive daily a softgel capsule consisting of 50 μg MK-7 Receives: Dietary Supplement: MK-7 containing capsule |
| nutrient enriched yogurt with MK-7 | Active comparator | one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil) Receives: Dietary Supplement: nutrient-enriched yogurt with MK-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in plasma MK-7 concentration after intervention between the three study groups
Measured: baseline and 6 weeks
Secondary outcomes (1)
The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cees Vermeer, PhD, Principal investigator, VitaK BV Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873274
- Sponsor's protocol ID
- 12-3-009
- Status last verified
- Jun 2013
- First submitted
- 30 May 2013
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Three Delivery Systems of Menaquinone-7
- ClinicalTrials.gov ID
- NCT01873274
- Acronym / sponsor ID
- 12-3-009
- Conditions
- Bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the absorption of menaquinone-7 from a nutrient-enriched dairy product compared to a general dairy product enriched with menaquinone-7 and a menaquinone-7-containing supplement.
Detailed description
In an earlier study, beneficial effects of a nutrient-enriched dairy product on vitamin K-status were observed. The study product contained menaquinone-7 (MK-7) and omega-3 fatty acids for vascular health and extra minerals and antioxidants to support general health. It was the first time that such low dose of MK-7 (50 µg) could significantly improve vascular and general vitamin K-status already after short-term treatment. From the results of this study, it was assumed that the matrix of the dairy product and/or other components in the product, in which the vitamin was offered, contributed to optimal absorption and availability of vitamin K2. In this new study, the uptake and efficacy of MK-7 from the nutrient enriched product is investigated and compared to the uptake and efficacy from a MK-7-containing supplement and a basic dairy product enriched with MK-7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| basic yogurt enriched with MK-7 | Active comparator | Dietary Supplement: basic yogurt enriched with MK-7one study group will receive daily two basic dairy products enriched with MK-7 (50 μg) |
| MK-7 containing capsule | Active comparator | Dietary Supplement: MK-7 containing capsuleone study group will receive daily a softgel capsule consisting of 50 μg MK-7 |
| nutrient enriched yogurt with MK-7 | Active comparator | Dietary Supplement: nutrient-enriched yogurt with MK-7one study group will receive daily two nutrient-enriched dairy products containing extra nutrients and omega-3 FA (fish-oil) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Apparently healthy men and postmenopausal women between 45 and 65 years old
- Subjects with body weight and height according to BMI between 20 and 30 kg/m2
- Subjects of Caucasian race
- Subject has given written consent to take part in the study
Key exclusion criteria (13 listed)
- Subjects with hypertension
- Subjects with hypercholesterolemia
- Subjects with (a history of) metabolic or gastrointestinal disease
- Subjects presenting chronic degenerative and/or inflammatory disease
- Subjects with (a history) of diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-7 containing capsule | Dietary supplement | MK-7 containing capsule |
| basic yogurt enriched with MK-7 | Dietary supplement | basic yogurt enriched with MK-7 |
| nutrient-enriched yogurt with MK-7 | Dietary supplement | nutrient enriched yogurt with MK-7 |
Primary outcome
The change in plasma MK-7 concentration after intervention between the three study groups
Time frame: baseline and 6 weeks
1 secondary outcome
The change in circulating markers of vitamin K-status, undercarboxylated osteocalcin and desphospho-uncarboxylated matrix Gla-protein, after intervention between the three study groups.
Time frame: baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cees Vermeer, PhD principal investigator
VitaK BV Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MK-7 containing capsule, basic yogurt enriched with MK-7 and nutrient-enriched yogurt with MK-7 in people with Bioavailability, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in plasma MK-7 concentration after intervention between the three study groups (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.