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| Sponsored by: |
Maastricht University Medical Center |
|---|---|
| Information provided by: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00732576 |
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: | Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency |
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
|
|
2: Active Comparator
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
Dietary Supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
|
|
3: Active Comparator
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
Dietary Supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
|
|
4: Active Comparator
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
Dietary Supplement: fish oil
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
|
|
5: Active Comparator
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
|
|
6: Active Comparator
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
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
|
|
7: Active Comparator
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
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
|
|
8: Active Comparator
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
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands | |
| VitaK - Maastricht University | |
| Maastricht, Netherlands, 6200 MD | |
| Principal Investigator: | Cees Vermeer, PhD | Department of Biochemistry, Maastricht University |
More Information
| Responsible Party: | VitaK BV ( Dr. C. Vermeer ) |
| Study ID Numbers: | MEC 07-3-067 |
| Study First Received: | October 10, 2007 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00732576 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Cardiovascular Calcification |
|
Arterial Occlusive Diseases Atherosclerosis Antiplasmin Vitamin MK 7 |
Vitamin K Vascular Diseases Arteriosclerosis Vitamin K 2 |
|
Coagulants Molecular Mechanisms of Pharmacological Action Growth Substances Hematologic Agents Physiological Effects of Drugs Hemostatics Pharmacologic Actions |
Fibrin Modulating Agents Antifibrinolytic Agents Therapeutic Uses Vitamins Cardiovascular Diseases Micronutrients |
