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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732576
• Other study ID #: MEC 07-3-067
• Status: Completed
• Phase: N/A
• First received: October 10, 2007
• Last updated: February 22, 2017
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: March 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• menaquinone-7
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
• fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
• krill oil
9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks

Locations

Country	Name	City	State
Netherlands	VitaK - Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endogenous Thrombin Potential (ETP)		12 weeks
Secondary	Osteocalcin carboxylation		12 weeks
Secondary	Matrix Gla-protein carboxylation		12 weeks