Skip to main content
OpenTrials
Completed

NCT Number: NCT02647333

Intervention With Omega Fatty Acids in High-risk Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid

Dietary Supplement

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.

Other names: Omega-3, N-3 Fatty Acid, Fish oil, N-3 PUFA

Omega-6 Fatty Acid

Dietary 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.

Other names: Omega-6, N-6 Fatty Acid, N-6 PUFA

Primary outcomes

  1. Changes in lipid profile

    Time frame: Measured at baseline and after 8 weeks

    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).

  2. Changes in particle concentrations of lipoproteins of different sizes

    Time frame: Measured at baseline and week 8

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

  3. Changes in lipoprotein particle sizes

    Time frame: Measured at baseline and week 8

    Lipoprotein particle size (nm) analysis will be performed by proton nuclear magnetic resonance (NMR) spectroscopy. The size will be derived from the sum of diameter of each subclass multiplied by its relative mass percentage based on its methyl NMR signal.

Secondary outcomes

  1. Changes in body composition

    Time frame: Measured at baseline and week 8

    Body composition will be measured by bioelectrical impedance (InBody 720).

  2. Changes in body weight

    Time frame: Measured at baseline and week 8

  3. Changes in waist and hip circumference

    Time frame: Measured at baseline and week 8

  4. Changes in circulating markers of inflammation, also including adipokines and kynurenine

    Time frame: Measured at baseline and week 8

    Inflammatory markers and adipokines will be measured in serum/plasma, e.g tumor necrosis factor-α (TNF-α), interleukins, macrophage inflammatory protein 1-α (MIP-1-α) and granulocyte-macrophage colony stimulating factor (GM-CSF).

  5. Changes in markers of inflammation in adipose tissue

    Time frame: Measured at baseline and week 8

    Inflammatory markers like TNF-α, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).

  6. Changes in one carbon metabolites

    Time frame: Measured at baseline and week 8

    Choline, betaine and related metabolites and B-vitamins involved in 1-carbon metabolism.

  7. Changes in microbiota

    Time frame: Measured at baseline and week 8

    Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).

  8. Changes in endothelial function

    Time frame: Measured at baseline and week 8

    Vascular reactivity index (VRI) will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol.

  9. Changes in carnitine and metabolites

    Time frame: Measured at baseline and week 8

    Trimethylamine N-oxide (TMAO), carnitine, acylcarnitines and fatty acids will be measured in serum/plasma.

  10. Changes in gene expression in adipose tissue

    Time frame: Measured at baseline and week 8

    Gene expression in adipose tissue will be measured by microarray and quantitative PCR.

  11. Changes in amino acids

    Time frame: Measured at baseline and week 8

    Amino acids, methylated amino acids and metabolites will be measured in serum/plasma.

  12. Changes in gene expression i whole blood

    Time frame: Measured at baseline and week 8

    Gene expression in full blood will be measured by quantitative PCR.

  13. Changes in apolipoproteins

    Time frame: Measured at baseline and week 8

    Apolipoproteins A1, A2, B, C2, C3 and E will be measured in serum by a multiplex kit.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen
  • University of Oslo

Registry information

Official study title

Intervention With Omega Fatty Acids in High-risk Patients With Hypertriglyceridemic Waist

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.