Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency

NCT ID: NCT00732576

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA)

Group Type ACTIVE_COMPARATOR

fish oil

Intervention Type DIETARY_SUPPLEMENT

9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks

2

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)

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

fish oil

Intervention Type DIETARY_SUPPLEMENT

9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks

3

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)

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

fish oil

Intervention Type DIETARY_SUPPLEMENT

9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks

4

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)

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

fish oil

Intervention Type DIETARY_SUPPLEMENT

9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks

5

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA)

Group Type ACTIVE_COMPARATOR

krill oil

Intervention Type DIETARY_SUPPLEMENT

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

6

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)

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

krill oil

Intervention Type DIETARY_SUPPLEMENT

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

7

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)

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

krill oil

Intervention Type DIETARY_SUPPLEMENT

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

8

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)

Group Type ACTIVE_COMPARATOR

menaquinone-7

Intervention Type DIETARY_SUPPLEMENT

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

krill oil

Intervention Type DIETARY_SUPPLEMENT

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

menaquinone-7

capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks

Intervention Type DIETARY_SUPPLEMENT

fish oil

9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

krill oil

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MenaQ7

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy subjects - BMI \< 30
* written informed consent

Exclusion Criteria

* Use of oral anticoagulants
* Coagulation disorders
* Use of multivitamin supplements
* Use of corticosteroids, anticonceptives
* hypertriglyceridemia, hypercholesterolemia
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

VitaK BV

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cees Vermeer, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biochemistry, Maastricht University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VitaK - Maastricht University

Maastricht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MEC 07-3-067

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fish Oil and Muscle Function
NCT01308957 COMPLETED NA