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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
menaquinone-7
fish oil
krill oil
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring Cardiovascular, Calcification

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VitaK - Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

6

7

8

Arm Description

9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA)

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)

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)

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)

9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA)

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)

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)

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)

Outcomes

Primary Outcome Measures

Endogenous Thrombin Potential (ETP)

Secondary Outcome Measures

Osteocalcin carboxylation
Matrix Gla-protein carboxylation

Full Information

First Posted
October 10, 2007
Last Updated
February 22, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00732576
Brief Title
Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
Official Title
Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Cardiovascular, Calcification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
9 fish oil capsules, equivalent to 3 gram per day of n-3 polyunsaturated fatty acids (PUFA)
Arm Title
2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
3
Arm Type
Active Comparator
Arm Description
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)
Arm Title
4
Arm Type
Active Comparator
Arm Description
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)
Arm Title
5
Arm Type
Active Comparator
Arm Description
9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA)
Arm Title
6
Arm Type
Active Comparator
Arm Description
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)
Arm Title
7
Arm Type
Active Comparator
Arm Description
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)
Arm Title
8
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
menaquinone-7
Other Intervention Name(s)
MenaQ7
Intervention Description
capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
fish oil
Intervention Description
9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
krill oil
Intervention Description
9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks
Primary Outcome Measure Information:
Title
Endogenous Thrombin Potential (ETP)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Osteocalcin carboxylation
Time Frame
12 weeks
Title
Matrix Gla-protein carboxylation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cees Vermeer, PhD
Organizational Affiliation
Department of Biochemistry, Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VitaK - Maastricht University
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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