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

Study Overview
=================
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.

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

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: menaquinone-7
* Dietary Supplement: fish oil
* Dietary Supplement: krill oil


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA) | Dietary Supplement: fish oil<br>* 9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks<br>|
| Active Comparator: 2<br>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<br>* capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks<br>* Other names: MenaQ7;Dietary Supplement: fish oil<br>* 9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks<br>|
| Active Comparator: 3<br>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<br>* capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks<br>* Other names: MenaQ7;Dietary Supplement: fish oil<br>* 9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks<br>|
| Active Comparator: 4<br>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<br>* capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks<br>* Other names: MenaQ7;Dietary Supplement: fish oil<br>* 9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks<br>|
| Active Comparator: 5<br>9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) | Dietary Supplement: krill oil<br>* 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks<br>|
| Active Comparator: 6<br>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<br>* capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks<br>* Other names: MenaQ7;Dietary Supplement: krill oil<br>* 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks<br>|
| Active Comparator: 7<br>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<br>* capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks<br>* Other names: MenaQ7;Dietary Supplement: krill oil<br>* 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks<br>|
| Active Comparator: 8<br>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<br>* capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks<br>* Other names: MenaQ7;Dietary Supplement: krill oil<br>* 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endogenous Thrombin Potential (ETP) |  | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular, Calcification