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

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00732576
First received: October 10, 2007
Last updated: March 9, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Atherosclerosis
Dietary Supplement: menaquinone-7
Dietary Supplement: fish oil
Dietary Supplement: krill oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Endogenous Thrombin Potential (ETP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Osteocalcin carboxylation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Matrix Gla-protein carboxylation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Name: MenaQ7
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: 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: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Name: MenaQ7
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: 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: menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Other Name: MenaQ7
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: 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 Name: 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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732576

Locations
Netherlands
VitaK - Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Cees Vermeer, PhD Department of Biochemistry, Maastricht University
  More Information

No publications provided

Responsible Party: Dr. C. Vermeer, VitaK BV
ClinicalTrials.gov Identifier: NCT00732576     History of Changes
Other Study ID Numbers: MEC 07-3-067
Study First Received: October 10, 2007
Last Updated: March 9, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Cardiovascular
Calcification

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin MK 7
Vitamin K 2
Vitamin K
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014