AtherosclerosisNCT00732576
Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
A study testing menaquinone-7, fish oil and krill oil in people with Atherosclerosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular calcification. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- menaquinone-7, fish oil and krill oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to May 2008
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects - BMI < 30
- written informed consent
Who cannot join
- Use of oral anticoagulants
- Coagulation disorders
- Use of multivitamin supplements
- Use of corticosteroids, anticonceptives
- hypertriglyceridemia, hypercholesterolemia
Trial locations and contacts
1 site in 1 country.
About this study
Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular calcification. In this study we investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of K2 vitamins.
- Conditions
- Atherosclerosis
- Being tested
- menaquinone-7, fish oil, krill oil
- Keywords
- Cardiovascular, Calcification
- Medical subject headings
- Atherosclerosis, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menaquinone-7Dietary supplement
Also called MenaQ7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
fish oilDietary supplement
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
krill oilDietary supplement
9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) Receives: Dietary Supplement: fish oil |
| 2 | Active comparator | 9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (10 µg) Receives: Dietary Supplement: menaquinone-7; Dietary Supplement: fish oil |
| 3 | Active comparator | 9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 2 capsules of menaquinone-7 per day (20 µg per day) Receives: Dietary Supplement: menaquinone-7; Dietary Supplement: fish oil |
| 4 | Active comparator | 9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (45 µg per day) Receives: Dietary Supplement: menaquinone-7; Dietary Supplement: fish oil |
| 5 | Active comparator | 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) Receives: Dietary Supplement: krill oil |
| 6 | Active comparator | 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (10 µg) Receives: Dietary Supplement: menaquinone-7; Dietary Supplement: krill oil |
| 7 | Active comparator | 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 2 capsules of menaquinone-7 per day (20 µg per day) Receives: Dietary Supplement: menaquinone-7; Dietary Supplement: krill oil |
| 8 | Active comparator | 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (45 µg per day) Receives: Dietary Supplement: menaquinone-7; Dietary Supplement: krill oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Thrombin Potential (ETP)
Measured: 12 weeks
Secondary outcomes (2)
Osteocalcin carboxylation
Measured: 12 weeks
Matrix Gla-protein carboxylation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Cees Vermeer, PhD, Principal investigator, Department of Biochemistry, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732576
- Sponsor's protocol ID
- MEC 07-3-067
- Status last verified
- Mar 2009
- First submitted
- 10 Oct 2007
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
- ClinicalTrials.gov ID
- NCT00732576
- Acronym / sponsor ID
- MEC 07-3-067
- Conditions
- Atherosclerosis
- Keywords
- Cardiovascular, Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Aug 2008 (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.
Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular calcification. In this study we investigate a potential synergy between the effects of either fish or krill oil and menaquinone-7, which is one of K2 vitamins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: fish oil9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) |
| 2 | Active comparator | Dietary Supplement: menaquinone-7, Dietary Supplement: fish oil9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (10 µg) |
| 3 | Active comparator | Dietary Supplement: menaquinone-7, Dietary Supplement: fish oil9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 2 capsules of menaquinone-7 per day (20 µg per day) |
| 4 | Active comparator | Dietary Supplement: menaquinone-7, Dietary Supplement: fish oil9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (45 µg per day) |
| 5 | Active comparator | Dietary Supplement: krill oil9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) |
| 6 | Active comparator | Dietary Supplement: menaquinone-7, Dietary Supplement: krill oil9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (10 µg) |
| 7 | Active comparator | Dietary Supplement: menaquinone-7, Dietary Supplement: krill oil9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 2 capsules of menaquinone-7 per day (20 µg per day) |
| 8 | Active comparator | Dietary Supplement: menaquinone-7, Dietary Supplement: krill oil9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) including 1 capsule of menaquinone-7 per day (45 µg per day) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects - BMI < 30
- written informed consent
Key exclusion criteria (5 listed)
- Use of oral anticoagulants
- Coagulation disorders
- Use of multivitamin supplements
- Use of corticosteroids, anticonceptives
- hypertriglyceridemia, hypercholesterolemia
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 |
|---|---|---|
| menaquinone-7Also: MenaQ7capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks | Dietary supplement | 2, 3, 4, 6, 7, 8 |
| fish oil9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks | Dietary supplement | 1, 2, 3, 4 |
| krill oil9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks | Dietary supplement | 5, 6, 7, 8 |
Primary outcome
Endogenous Thrombin Potential (ETP)
Time frame: 12 weeks
2 secondary outcomes
Osteocalcin carboxylation
Time frame: 12 weeks
Matrix Gla-protein carboxylation
Time frame: 12 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 24 Feb 2017.
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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
Department of Biochemistry, 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 menaquinone-7, fish oil and krill oil in people with Atherosclerosis, 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 2 inclusion and 5 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 24 Feb 2017. 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?
Endogenous Thrombin Potential (ETP) (time frame: 12 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 24 Feb 2017.