Intervention With Omega Fatty Acids in High-risk Patients
NCT ID: NCT02647333
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2015-03-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Omega-3 fatty acid
Omega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.
Omega-3 Fatty Acid
Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively. The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.
Omega-6 fatty acid
Omega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.
Omega-6 Fatty Acid
Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively. The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
Interventions
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Omega-3 Fatty Acid
Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively. The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.
Omega-6 Fatty Acid
Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively. The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physical inactivity (\< 2 h vigorous/active exercise training per week)
Exclusion Criteria
* Severe psychiatric illness
* Pregnancy
* Pacemaker or implantable cardioverter defibrillator
* Cigarette smoking
* Previous coronary intervention
* Concomitant use of dietary supplements
* Use of omega-3 supplements at baseline
* Alcohol or drug abuse or any condition associated with poor compliance.
* Scheduled hospitalisation during the course of the study.
* Participation in a clinical trial in the last 12 weeks, or prior randomisation.
* Blood donation within the preceding 12 weeks.
* Diabetes Mellitus Type 1 or type 2
* Triglycerides \> 5 mmol/l
* Previous bariatric surgery
* Malabsorption disorder
30 Years
70 Years
ALL
Yes
Sponsors
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University of Bergen
OTHER
University of Oslo
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Espen Rostrup, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital, Department of Heart Disease
References
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Laupsa-Borge J, Grytten E, Bohov P, Bjorndal B, Strand E, Skorve J, Nordrehaug JE, Berge RK, Rostrup E, Mellgren G, Dankel SN, Nygard OK. Sex-specific responses in glucose-insulin homeostasis and lipoprotein-lipid components after high-dose supplementation with marine n-3 PUFAs in abdominal obesity: a randomized double-blind crossover study. Front Nutr. 2023 Jun 19;10:1020678. doi: 10.3389/fnut.2023.1020678. eCollection 2023.
Grytten E, Laupsa-Borge J, Bohov P, Bjorndal B, Strand E, Skorve J, Nordrehaug JE, Berge RK, Rostrup E, Mellgren G, Dankel SN, Nygard OK. Changes in lipoprotein particle subclasses, standard lipids, and apolipoproteins after supplementation with n-3 or n-6 PUFAs in abdominal obesity: A randomized double-blind crossover study. Clin Nutr. 2021 May;40(5):2556-2575. doi: 10.1016/j.clnu.2021.03.040. Epub 2021 Apr 3.
Other Identifiers
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2014/2336
Identifier Type: -
Identifier Source: org_study_id