Plasma Omega-3 StatusNCT03245749
Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition
An observational study of Plasma Omega-3 Status, run by University of Southampton at 5 sites in United Kingdom.
Trial summary
The purpose of this study is to investigate the effect of habitual oily fish intake, sex, age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plasma Omega-3 Status
- How many people
- 374 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jun 2003to Mar 2006
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Individuals residing in Southampton, East Anglia, Glasgow and Newcastle
Who may be able to join
None listed.
Who cannot join
- Diagnosed endocrine dysfunction including diabetes
- Fasting glucose concentration > 6.5 mmol/L
- Myocardial infarction in the previous 2 years
- The use of medication that may interfere with lipid metabolism
- Fasting total cholesterol of > 8.0 mmol/L
- TG of > 3.0 mmol/L
- Currently following a weight loss diet
- Taking n-3 fatty acid supplements
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University of Glasgow
Glasgow
Newcastle University
Newcastle upon Tyne
Univeristy of East Anglia
Norwich
University of Reading
Reading
University of Southampton
Southampton
About this study
The purpose of this study is to investigate the effect of habitual oily fish intake, sex, age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.
Read the detailed description
The marine long chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial to cardiovascular and cognitive health and the concentration of EPA and DHA present in blood and tissue lipids is positively correlated with these effects.
As a result, national and global authorities recommend regular consumption of oily fish in order to provide approximately 500 mg EPA+DHA per day in a healthy population. However, the associations between EPA and DHA intake and blood and tissue status, and therefore physiological benefits, are highly variable and the factors influencing this heterogeneity are not well understood.
This study aims to investigate the effect of habitual oily fish intake as well as sex, age, BMI, and Apolipoprotein E (APOE) genotype on LC n-3 PUFA status in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols in order to obtain greater knowledge of the determinants of LC n-3 PUFA status with the potential to develop more robust, and perhaps subgroup specific, recommendations for EPA and DHA intake.
- Conditions
- Plasma Omega-3 Status
- Keywords
- omega-3 status, blood lipids, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma long chain n-3 polyunsaturated fatty acid concentrations
Concentrations of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols
Measured: Baseline
Secondary outcomes (2)
APOE genotyping
APOE genotype determined from blood sample
Measured: Baseline
Anthropometric measurements
Height and weight to determine BMI
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startJun 2003
- Primary completionSep 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasma Omega-3 StatusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Food Standards Agency, United Kingdom, Ocean Nutrition
- Responsible party
- Sponsor
- Investigators
- Philip C Calder, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245749
- Sponsor's protocol ID
- RRD7/N02/A
- Status last verified
- Jul 2021
- First submitted
- 7 Aug 2017
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisk HL, Irvine M, Miles EA, Lietz G, Mathers JC, Packard CJ, Armah CK, Kofler BM, Curtis PJ, Minihane AM, Calder PC. Association of oily fish intake, sex, age, BMI and APOE genotype with plasma long-chain n-3 fatty acid composition. Br J Nutr. 2018 Jul;120(1):23-32. doi: 10.1017/S000711451800106X. Epub 2018 May 6.
PubMed 29729672
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oily Fish Intake, Sex, Age, BMI, and APOE Genotype on Plasma Long Chain n-3 Fatty Acid Composition
- ClinicalTrials.gov ID
- NCT03245749
- Acronym / sponsor ID
- RRD7/N02/A
- Conditions
- Plasma Omega-3 Status
- Keywords
- omega-3 status, blood lipids, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Food Standards Agency, United Kingdom, Ocean Nutrition
- Study start
- Jun 2003 (actual)
- Primary completion
- Sep 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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 purpose of this study is to investigate the effect of habitual oily fish intake, sex, age, BMI, and APOE genotype on plasma long chain n-3 fatty acid composition.
Detailed description
The marine long chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial to cardiovascular and cognitive health and the concentration of EPA and DHA present in blood and tissue lipids is positively correlated with these effects.
As a result, national and global authorities recommend regular consumption of oily fish in order to provide approximately 500 mg EPA+DHA per day in a healthy population. However, the associations between EPA and DHA intake and blood and tissue status, and therefore physiological benefits, are highly variable and the factors influencing this heterogeneity are not well understood.
This study aims to investigate the effect of habitual oily fish intake as well as sex, age, BMI, and Apolipoprotein E (APOE) genotype on LC n-3 PUFA status in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols in order to obtain greater knowledge of the determinants of LC n-3 PUFA status with the potential to develop more robust, and perhaps subgroup specific, recommendations for EPA and DHA intake.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals residing in Southampton, East Anglia, Glasgow and Newcastle
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Diagnosed endocrine dysfunction including diabetes
- Fasting glucose concentration > 6.5 mmol/L
- Myocardial infarction in the previous 2 years
- The use of medication that may interfere with lipid metabolism
- Fasting total cholesterol of > 8.0 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma long chain n-3 polyunsaturated fatty acid concentrations
Time frame: Baseline
Concentrations of eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA) in plasma phosphatidylcholine, non-esterified fatty acids, cholesteryl esters and triacylglycerols
2 secondary outcomes
APOE genotyping
Time frame: Baseline
Anthropometric measurements
Time frame: Baseline
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 8 Jul 2021.
- Results publication: PubMed 29729672Fisk HL, Irvine M, Miles EA, Lietz G, Mathers JC, Packard CJ, Armah CK, Kofler BM, Curtis PJ, Minihane AM, Calder PC. Association of oily fish intake, sex, age, BMI and APOE genotype with plasma long-chain n-3 fatty acid composition. Br J Nutr. 2018 Jul;120(1):23-32. doi: 10.1017/S000711451800106X. Epub 2018 May 6.
- Individual participant dataSharing planned: No
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.
Philip C Calder principal investigator
University of Southampton
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Omega-3 Status, run by University of Southampton at 5 sites in United Kingdom.
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 0 inclusion and 8 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Plasma long chain n-3 polyunsaturated fatty acid concentrations (time frame: Baseline). 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 NCT03245749, which also lists 1 linked publication.
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 8 Jul 2021.