Intervention With Omega Fatty Acids in High-risk Patients

Haukeland University Hospital

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Omega-6 Fatty Acid; Dietary Supplement: Omega-3 Fatty Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02647333

2014/2336

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Omega-3 fatty acid

Experimental group

Description:

Omega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.

Treatment:

Dietary Supplement: Omega-3 Fatty Acid

Omega-6 fatty acid

Experimental group

Description:

Omega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.

Treatment:

Dietary Supplement: Omega-6 Fatty Acid