Intervention With Omega Fatty Acids in High-risk Patients

Haukeland University Hospital40 enrolled

Overview

In order to reduce cardiovascular risk, current European guidelines recommend a diet low on saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA). Polyunsaturated fatty acids can be classified into omega-3 and omega-6. However the results from recent meta-analyses investigating coronary risk outcomes did not clearly support a low intake of saturated fatty acids and a high intake of omega-3 or omega-6. The aim of this study is to investigate the short term effects of a high intake of PUFAs on microvascular function, lipids, inflammation and other cardiovascular risk factors in inactive patients with increased waistline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Cardiovascular Disease

Interventions

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 AcidDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Waist circumference ≥ 94 cm in men and ≥ 80 cm in women * Physical inactivity (\< 2 h vigorous/active exercise training per week) Exclusion Criteria: * Regular use of certain prescription medications at baseline * 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

Outcomes

Primary Outcomes

Changes in lipid profile

High-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol and triglycerides (TG) will be measured in plasma/serum (mmol/L).

Time frame: Measured at baseline and after 8 weeks

Changes in particle concentrations of lipoproteins of different sizes

Particle concentration (nmol/L) of lipoprotein of different sizes will be calculated from the measured amplitude of their spectroscopically lipid methyl group NMR signals.