Intervention With Omega Fatty Acids in High-risk Patients

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647333
• Other study ID #: 2014/2336
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2015
• Last updated: December 19, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2016
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Omega-3 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.
• Omega-6 Fatty Acid
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen, University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Measured at baseline and after 8 weeks	No
Primary	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.	Measured at baseline and week 8	No
Primary	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.	Measured at baseline and week 8	No
Secondary	Changes in body composition	Body composition will be measured by bioelectrical impedance (InBody 720).	Measured at baseline and week 8	No
Secondary	Changes in body weight		Measured at baseline and week 8	No
Secondary	Changes in waist and hip circumference		Measured at baseline and week 8	No
Secondary	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-a (TNF-a), interleukins, macrophage inflammatory protein 1-a (MIP-1-a) and granulocyte-macrophage colony stimulating factor (GM-CSF).	Measured at baseline and week 8	No
Secondary	Changes in markers of inflammation in adipose tissue	Inflammatory markers like TNF-a, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).	Measured at baseline and week 8	No
Secondary	Changes in one carbon metabolites	Choline, betaine and related metabolites and B-vitamins involved in 1-carbon metabolism.	Measured at baseline and week 8	No
Secondary	Changes in microbiota	Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).	Measured at baseline and week 8	No
Secondary	Changes in endothelial function	Vascular reactivity index (VRI) will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol.	Measured at baseline and week 8	No
Secondary	Changes in carnitine and metabolites	Trimethylamine N-oxide (TMAO), carnitine, acylcarnitines and fatty acids will be measured in serum/plasma.	Measured at baseline and week 8	No
Secondary	Changes in gene expression in adipose tissue	Gene expression in adipose tissue will be measured by microarray and quantitative PCR.	Measured at baseline and week 8	No
Secondary	Changes in amino acids	Amino acids, methylated amino acids and metabolites will be measured in serum/plasma.	Measured at baseline and week 8	No
Secondary	Changes in gene expression i whole blood	Gene expression in full blood will be measured by quantitative PCR.	Measured at baseline and week 8	No
Secondary	Changes in apolipoproteins	Apolipoproteins A1, A2, B, C2, C3 and E will be measured in serum by a multiplex kit.	Measured at baseline and week 8	No