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

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: menaquinone-7; Dietary Supplement: krill oil; Dietary Supplement: fish oil

• Registration Number: NCT00732576
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-10
• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-12
• Status Verified: 2009-03
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	menaquinone-7	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)
2	menaquinone-7	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)
5	krill oil	9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA)
2	fish oil	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)
1	fish oil	9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA)
3	menaquinone-7	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)
6	krill oil	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)
3	fish oil	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)
6	menaquinone-7	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)
7	menaquinone-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)
7	krill oil	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)
8	menaquinone-7	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)
8	krill oil	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)
4	fish oil	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)

Primary Outcome Measures

Name	Time	Method
Endogenous Thrombin Potential (ETP)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Osteocalcin carboxylation	12 weeks
Matrix Gla-protein carboxylation	12 weeks

Trial Locations

Locations (1)

VitaK - Maastricht University; 🇳🇱 Maastricht, Netherlands