Omega-3 Fatty Acids and Health Effects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Stine Marie Ulven, Akershus University College

ClinicalTrials.gov Identifier:

NCT01034423

First received: December 16, 2009

Last updated: November 21, 2011

Last verified: November 2011

History of Changes

Purpose

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

Condition	Intervention
Healthy	Dietary Supplement: Omega-3 Dietary Supplement: sun flower oil

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Omega-3 Fatty Acids and Health Effects

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Akershus University College:

Primary Outcome Measures:

Primary and secondary oxidation products [ Time Frame: baseline (0 weeks), 3 weeks and 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

inflammatory markers [ Time Frame: after 0,3 and 7 weeks ] [ Designated as safety issue: No ]

Enrollment:	69
Study Start Date:	September 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: omega-3 high quality	Dietary Supplement: Omega-3 Capsules with omega-3 fatty acids. Dietary Supplement: sun flower oil Capsules with sun flower oil.
Experimental: omega-3 low quality	Dietary Supplement: Omega-3 Capsules with omega-3 fatty acids. Dietary Supplement: sun flower oil Capsules with sun flower oil.
Placebo Comparator: placebo	Dietary Supplement: Omega-3 Capsules with omega-3 fatty acids. Dietary Supplement: sun flower oil Capsules with sun flower oil.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy individuals.

Exclusion Criteria:

Pregnant women, lactating women, chronic diseases and smoking.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034423

Sponsors and Collaborators

Akershus University College

Investigators

Study Chair:

Stine Marie Ulven, PhD

Akershus University College

More Information

No publications provided by Akershus University College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ottestad I, Hassani S, Borge GI, Kohler A, Vogt G, Hyötyläinen T, Orešič M, Brønner 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, Retterstøl K, Myhrstad MC, Haugen JE, Nilsson A, Ravn-Haren G, Nordvi B, Brønner 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. Epub 2011 Dec 5.

Responsible Party:	Stine Marie Ulven, Associate Professor, Akershus University College
ClinicalTrials.gov Identifier:	NCT01034423 History of Changes
Other Study ID Numbers:	6.2008.2215
Study First Received:	December 16, 2009
Last Updated:	November 21, 2011
Health Authority:	Norway:Regional Committees for Medical and Health Research Ethics

Keywords provided by Akershus University College:

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

ClinicalTrials.gov processed this record on June 18, 2013

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