Intervention With Omega Fatty Acids in High-risk Patients

Plain-language summary

This study investigated the effects of omega-3 and omega-6 fatty acid supplements in people at high cardiovascular risk. It enrolled people with a large waist circumference (≥94 cm in men, ≥80 cm in women) who were physically inactive. It was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Haukeland University Hospital

Intervention

Omega-3 Fatty Acid, Omega-6 Fatty Acid

Start date

3/1/2015

Estimated completion

4/1/2016

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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