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

February 22, 2017 updated by: Maastricht University Medical Center
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6200 MD
        • VitaK - Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA)
Dietary supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
Active Comparator: 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)
Dietary supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
Dietary supplement: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Names:
  • MenaQ7
Active Comparator: 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)
Dietary supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
Dietary supplement: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Names:
  • MenaQ7
Active Comparator: 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)
Dietary supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
Dietary supplement: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Names:
  • MenaQ7
Active Comparator: 5
9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA)
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
Active Comparator: 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)
Dietary supplement: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Names:
  • MenaQ7
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
Active Comparator: 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)
Dietary supplement: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Names:
  • MenaQ7
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
Active Comparator: 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)
Dietary supplement: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Names:
  • MenaQ7
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endogenous Thrombin Potential (ETP)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Osteocalcin carboxylation
Time Frame: 12 weeks
12 weeks
Matrix Gla-protein carboxylation
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Cees Vermeer, PhD, Department of Biochemistry, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 07-3-067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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