NCT02647333

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

September 9, 2015

Last Update Submit

December 19, 2016

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (13)

  • Changes in body composition

    Measured at baseline and week 8

  • Changes in body weight

    Measured at baseline and week 8

  • Changes in waist and hip circumference

    Measured at baseline and week 8

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

    Measured at baseline and week 8

  • Changes in markers of inflammation in adipose tissue

    Measured at baseline and week 8

  • +8 more secondary outcomes

Study Arms (2)

Omega-3 fatty acid

EXPERIMENTAL

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 acid

EXPERIMENTAL

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

Interventions

Omega-3 Fatty AcidDIETARY_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.

Also known as: Omega-3, N-3 Fatty Acid, Fish oil, N-3 PUFA
Omega-3 fatty acid
Omega-6 Fatty AcidDIETARY_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.

Also known as: Omega-6, N-6 Fatty Acid, N-6 PUFA
Omega-6 fatty acid

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 37404855DERIVED

  • 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.

    PMID: 33933722DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fatty Acids, Omega-3Docosahexaenoic AcidsFish OilsFatty Acids, Omega-6

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOils

Study Officials

  • Espen Rostrup, MD PhD

    Haukeland University Hospital, Department of Heart Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

January 6, 2016

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12