Clinical Trial: Intervention With Omega Fatty Acids in High-risk Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Haukeland University Hospital

Current Primary Outcome:

  • 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).
  • 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.
  • 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.


Original Primary Outcome: Changes in lipid profile [ Time Frame: Measured at baseline and week 6, 8 and 14. ]

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


Current Secondary Outcome:

  • Changes in body composition [ Time Frame: Measured at baseline and week 8 ]
    Body composition will be measured by bioelectrical impedance (InBody 720).
  • Changes in body weight [ Time Frame: Measured at baseline and week 8 ]
  • Changes in waist and hip circumference [ Time Frame: Measured at baseline and week 8 ]
  • 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • Changes in body composition [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    Body composition will be measured by bioelectrical impedance (InBody 720).
  • Changes in body weight [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
  • Changes in waist and hip circumference [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
  • Changes in markers of inflammation in plasma [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    Tumor necrosis factor-α (TNF-α), interleukins, macrophage inflammatory protein 1-α (MIP-1-α) and granulocyte-macrophage colony stimulating factor (GM-CSF) will be measured in plasma (pg/mL).
  • Changes in markers of inflammation in adipose tissue [ Time Frame: Measured at baseline and week 6. ]
    TNF-α, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).
  • Changes in one carbon metabolites [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    Plasma choline, betaine, carnitine and acylcarnitines will be analysed in plasma (µmol/mL).
  • Changes in microbiota [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).
  • Changes in endothelial function [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    Vascular reactivity will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol, presented as reactive hyperaemia index (RHI).
  • Changes in lipoprotein particle size [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    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.
  • Changes in lipoprotein particle concentration of different sizes [ Time Frame: Measured at baseline and week 6, 8 and 14. ]
    Particle concentration (nmol/L) of lipoprotein of different sizes will be calculated from the measured amplitude of their spectroscopically lipid methyl group NMR signals.


Information By: Haukeland University Hospital

Dates:
Date Received: September 9, 2015
Date Started: March 2015
Date Completion:
Last Updated: December 19, 2016
Last Verified: December 2016