A Phase 2 interventional study of Omega-3 Fatty Acid and Omega-6 Fatty Acid in Cardiovascular Disease, sponsored by Haukeland University Hospital. Completed. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by Haukeland University Hospital · Phase 2, Interventional, and Prevention
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.
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This study's enrollment of 40 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Omega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.
Dietary Supplement: Omega-3 Fatty Acid
Omega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.
Dietary Supplement: Omega-6 Fatty Acid
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.
Also known as: Omega-3, N-3 Fatty Acid, Fish oil, N-3 PUFA
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.
Also known as: Omega-6, N-6 Fatty Acid, N-6 PUFA
Changes in lipid profile
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).
Time frame: Measured at baseline and after 8 weeks
Changes in particle concentrations of lipoproteins of different sizes
Particle concentration (nmol/L) of lipoprotein of different sizes will be calculated from the measured amplitude of their spectroscopically lipid methyl group NMR signals.
Time frame: Measured at baseline and week 8
Changes in lipoprotein particle sizes
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.
Time frame: Measured at baseline and week 8
Changes in body composition
Body composition will be measured by bioelectrical impedance (InBody 720).
Time frame: Measured at baseline and week 8
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
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).
Time frame: Measured at baseline and week 8
Changes in markers of inflammation in adipose tissue
Inflammatory markers like TNF-α, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).
Time frame: Measured at baseline and week 8
Changes in one carbon metabolites
Choline, betaine and related metabolites and B-vitamins involved in 1-carbon metabolism.
Time frame: Measured at baseline and week 8
Changes in microbiota
Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).
Time frame: Measured at baseline and week 8
Changes in endothelial function
Vascular reactivity index (VRI) will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol.
Time frame: Measured at baseline and week 8
Changes in carnitine and metabolites
Trimethylamine N-oxide (TMAO), carnitine, acylcarnitines and fatty acids will be measured in serum/plasma.
Time frame: Measured at baseline and week 8
Changes in gene expression in adipose tissue
Gene expression in adipose tissue will be measured by microarray and quantitative PCR.
Time frame: Measured at baseline and week 8
Changes in amino acids
Amino acids, methylated amino acids and metabolites will be measured in serum/plasma.
Time frame: Measured at baseline and week 8
Changes in gene expression i whole blood
Gene expression in full blood will be measured by quantitative PCR.
Time frame: Measured at baseline and week 8
Changes in apolipoproteins
Apolipoproteins A1, A2, B, C2, C3 and E will be measured in serum by a multiplex kit.
Time frame: Measured at baseline and week 8
No study locations are listed for this record.
The record gives a start of Mar 2015, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
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