Clinical trial NCT02647333: Intervention With Omega Fatty Acids in High-risk Patients
Official title: Intervention With Omega Fatty Acids in High-risk Patients With Hypertriglyceridemic Waist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: University of Oslo
First posted: 2016-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in lipid profile
timeFrame: Measured at baseline and after 8 weeks
measure: Changes in particle concentrations of lipoproteins of different sizes
timeFrame: Measured at baseline and week 8
measure: Changes in lipoprotein particle sizes
timeFrame: Measured at baseline and week 8
Secondary outcomes:
measure: Changes in body composition
timeFrame: Measured at baseline and week 8
measure: Changes in body weight
timeFrame: Measured at baseline and week 8
measure: Changes in waist and hip circumference
timeFrame: Measured at baseline and week 8
measure: Changes in circulating markers of inflammation, also including adipokines and kynurenine
timeFrame: Measured at baseline and week 8
measure: Changes in markers of inflammation in adipose tissue
timeFrame: Measured at baseline and week 8
measure: Changes in one carbon metabolites
timeFrame: Measured at baseline and week 8
measure: Changes in microbiota
timeFrame: Measured at baseline and week 8
measure: Changes in endothelial function
timeFrame: Measured at baseline and week 8
measure: Changes in carnitine and metabolites
timeFrame: Measured at baseline and week 8
measure: Changes in gene expression in adipose tissue
timeFrame: Measured at baseline and week 8
measure: Changes in amino acids
timeFrame: Measured at baseline and week 8
measure: Changes in gene expression i whole blood
timeFrame: Measured at baseline and week 8
measure: Changes in apolipoproteins
timeFrame: Measured at baseline and week 8
Other outcomes:
Locations:
Study officials:
affiliation: Haukeland University Hospital, Department of Heart Disease
name: Espen Rostrup, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.