HealthyNCT01034423
Omega-3 Fatty Acids and Health Effects
A study testing Omega-3 and sun flower oil in people with Healthy, run by Oslo Metropolitan University.
Trial summary
The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Omega-3 and sun flower oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2009
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals.
Who cannot join
- Pregnant women, lactating women, chronic diseases and smoking.
About this study
The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality.
- Conditions
- Healthy
- Being tested
- Omega-3, sun flower oil
- Keywords
- Focus: health effects from omega-3 fatty acids, from fish oil with different quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Capsules with omega-3 fatty acids.
sun flower oilDietary supplement
Capsules with sun flower oil.
| Study group | Role | What they receive |
|---|---|---|
| omega-3 high quality | Experimental | Not described Receives: Dietary Supplement: Omega-3; Dietary Supplement: sun flower oil |
| omega-3 low quality | Experimental | Not described Receives: Dietary Supplement: Omega-3; Dietary Supplement: sun flower oil |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: Omega-3; Dietary Supplement: sun flower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary and secondary oxidation products
Measured: baseline (0 weeks), 3 weeks and 7 weeks
Secondary outcomes (1)
inflammatory markers
Measured: after 0,3 and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stine Marie Ulven, Oslo Metropolitan University
- Investigators
- Stine M Ulven, PhD, Study chair, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034423
- Sponsor's protocol ID
- 6.2008.2215
- Status last verified
- Feb 2015
- First submitted
- 16 Dec 2009
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27551317Myhrstad 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.
PubMed 24641624Ottestad 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.
PubMed 22952598Ottestad 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.
PubMed 22136711
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and Health Effects
- ClinicalTrials.gov ID
- NCT01034423
- Acronym / sponsor ID
- 6.2008.2215
- Conditions
- Healthy
- Keywords
- Focus: health effects from omega-3 fatty acids, from fish oil with different quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to study health effects from omega-3 fatty acids, from fishoil with different quality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| omega-3 high quality | Experimental | Dietary Supplement: Omega-3, Dietary Supplement: sun flower oil |
| omega-3 low quality | Experimental | Dietary Supplement: Omega-3, Dietary Supplement: sun flower oil |
| placebo | Placebo comparator | Dietary Supplement: Omega-3, Dietary Supplement: sun flower oil |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals.
Key exclusion criteria (1 listed)
- Pregnant women, lactating women, chronic diseases and smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Capsules with omega-3 fatty acids. | Dietary supplement | omega-3 high quality, omega-3 low quality, placebo |
| sun flower oilCapsules with sun flower oil. | Dietary supplement | omega-3 high quality, omega-3 low quality, placebo |
Primary outcome
Primary and secondary oxidation products
Time frame: baseline (0 weeks), 3 weeks and 7 weeks
1 secondary outcome
inflammatory markers
Time frame: after 0,3 and 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Derived from this study: PubMed 27551317Myhrstad 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.
- Derived from this study: PubMed 24641624Myhrstad 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.
- Derived from this study: PubMed 22952598Ottestad 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.
- Derived from this study: PubMed 22136711Ottestad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stine M Ulven, PhD study chair
Oslo Metropolitan University
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 and sun flower oil in people with Healthy, run by Oslo Metropolitan University.
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 1 inclusion and 1 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 4 Feb 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Primary and secondary oxidation products (time frame: baseline (0 weeks), 3 weeks and 7 weeks). 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 NCT01034423, which also lists 4 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 4 Feb 2015.