NCT01034423

Brief Summary

The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable healthy

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

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

December 16, 2009

Last Update Submit

February 3, 2015

Conditions

Keywords

Focus: health effects from omega-3 fatty acids, from fish oil with different quality

Outcome Measures

Primary Outcomes (1)

  • Primary and secondary oxidation products

    baseline (0 weeks), 3 weeks and 7 weeks

Secondary Outcomes (1)

  • inflammatory markers

    after 0,3 and 7 weeks

Study Arms (3)

omega-3 high quality

EXPERIMENTAL
Dietary Supplement: Omega-3Dietary Supplement: sun flower oil

omega-3 low quality

EXPERIMENTAL
Dietary Supplement: Omega-3Dietary Supplement: sun flower oil

placebo

PLACEBO COMPARATOR
Dietary Supplement: Omega-3Dietary Supplement: sun flower oil

Interventions

Omega-3DIETARY_SUPPLEMENT

Capsules with omega-3 fatty acids.

omega-3 high qualityomega-3 low qualityplacebo
sun flower oilDIETARY_SUPPLEMENT

Capsules with sun flower oil.

omega-3 high qualityomega-3 low qualityplacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals.

You may not qualify if:

  • Pregnant women, lactating women, chronic diseases and smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Myhrstad MC, Ottestad I, Gunther CC, Ryeng E, Holden M, Nilsson A, Bronner KW, Kohler A, Borge GI, Holven KB, Ulven SM. The PBMC transcriptome profile after intake of oxidized versus high-quality fish oil: an explorative study in healthy subjects. Genes Nutr. 2016 May 31;11:16. doi: 10.1186/s12263-016-0530-6. eCollection 2016.

  • Myhrstad MC, Ulven SM, Gunther CC, Ottestad I, Holden M, Ryeng E, Borge GI, Kohler A, Bronner KW, Thoresen M, Holven KB. Fish oil supplementation induces expression of genes related to cell cycle, endoplasmic reticulum stress and apoptosis in peripheral blood mononuclear cells: a transcriptomic approach. J Intern Med. 2014 Nov;276(5):498-511. doi: 10.1111/joim.12217. Epub 2014 Mar 20.

  • Ottestad I, Hassani S, Borge GI, Kohler A, Vogt G, Hyotylainen T, Oresic M, Bronner KW, Holven KB, Ulven SM, Myhrstad MC. Fish oil supplementation alters the plasma lipidomic profile and increases long-chain PUFAs of phospholipids and triglycerides in healthy subjects. PLoS One. 2012;7(8):e42550. doi: 10.1371/journal.pone.0042550. Epub 2012 Aug 28.

  • Ottestad I, Vogt G, Retterstol K, Myhrstad MC, Haugen JE, Nilsson A, Ravn-Haren G, Nordvi B, Bronner KW, Andersen LF, Holven KB, Ulven SM. Oxidised fish oil does not influence established markers of oxidative stress in healthy human subjects: a randomised controlled trial. Br J Nutr. 2012 Jul;108(2):315-26. doi: 10.1017/S0007114511005484. Epub 2011 Dec 5.

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Stine M Ulven, PhD

    Oslo Metropolitan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 4, 2015

Record last verified: 2015-02