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AzTrials

Cardiovascular DiseasePhase 2NCT02647333

Intervention With Omega Fatty Acids in High-risk Patients

A Phase 2 study testing Omega-3 Fatty Acid and Omega-6 Fatty Acid in people with Cardiovascular Disease, run by Haukeland University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
Omega-3 Fatty Acid and Omega-6 Fatty Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Mar 2015to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Waist circumference ≥ 94 cm in men and ≥ 80 cm in women
  • Physical inactivity (< 2 h vigorous/active exercise training per week)

Who cannot join

  • Regular use of certain prescription medications at baseline
  • Severe psychiatric illness
  • Pregnancy
  • Pacemaker or implantable cardioverter defibrillator
  • Cigarette smoking
  • Previous coronary intervention
Show all 16Show fewer
  • 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

About this study

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

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.

Being tested
Omega-3 Fatty Acid, Omega-6 Fatty Acid
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega-3 Fatty AcidDietary supplement

    Also called Omega-3, N-3 Fatty Acid, Fish oil, N-3 PUFA

    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 AcidDietary supplement

    Also called Omega-6, N-6 Fatty Acid, N-6 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.

Study groups in NCT02647333
Study groupRoleWhat they receive
Omega-3 fatty acidExperimentalOmega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.
Receives: Dietary Supplement: Omega-3 Fatty Acid
Omega-6 fatty acidExperimentalOmega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.
Receives: Dietary Supplement: Omega-6 Fatty Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured at baseline and after 8 weeks

  2. 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: Measured at baseline and week 8

  3. 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: Measured at baseline and week 8

Secondary outcomes (13)

  1. Changes in body composition

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

    Measured: Measured at baseline and week 8

  2. Changes in body weight

    Measured: Measured at baseline and week 8

  3. Changes in waist and hip circumference

    Measured: Measured at baseline and week 8

  4. 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).

    Measured: Measured at baseline and week 8

  5. 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).

    Measured: Measured at baseline and week 8

  6. Changes in one carbon metabolites

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

    Measured: Measured at baseline and week 8

  7. 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: Measured at baseline and week 8

  8. Changes in endothelial function

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

    Measured: Measured at baseline and week 8

  9. Changes in carnitine and metabolites

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

    Measured: Measured at baseline and week 8

  10. Changes in gene expression in adipose tissue

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

    Measured: Measured at baseline and week 8

  11. Changes in amino acids

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

    Measured: Measured at baseline and week 8

  12. Changes in gene expression i whole blood

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

    Measured: Measured at baseline and week 8

  13. Changes in apolipoproteins

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

    Measured: Measured at baseline and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02647333
Sponsor's protocol ID
2014/2336
Status last verified
Dec 2016
First submitted
9 Sep 2015
Last updated
20 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Laupsa-Borge J, Grytten E, Bohov P, Bjorndal B, Strand E, Skorve J, Nordrehaug JE, Berge RK, Rostrup E, Mellgren G, Dankel SN, Nygard OK. Sex-specific responses in glucose-insulin homeostasis and lipoprotein-lipid components after high-dose supplementation with marine n-3 PUFAs in abdominal obesity: a randomized double-blind crossover study. Front Nutr. 2023 Jun 19;10:1020678. doi: 10.3389/fnut.2023.1020678. eCollection 2023.

    PubMed 37404855

  • 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.

    PubMed 33933722

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega-3 Fatty Acid and Omega-6 Fatty Acid in people with Cardiovascular Disease, run by Haukeland University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in lipid profile (time frame: Measured at baseline and after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02647333, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.

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