HealthyNCT03477045
Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?
A study testing Single dose fish oil, Repeated dose fish oil and single dose Camelina seed oil in people with Healthy, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be beneficial to health. Many people consume little, despite UK government recommendations to eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish stocks are declining due to over fishing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Single dose fish oil, Repeated dose fish oil and single dose Camelina seed oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jun 2017to 4 Nov 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- 18 to 30 years or 50 to 65 years
- Body mass index 18.5-30.0 kg/m2
- Health screening results that are within normal clinical ranges
- Not consuming fish oil or other oil supplements
- Not eating more than one oily fish meal per week
- Willing to adhere to the study protocol
- Being able to provide written informed consent
Who cannot join
- Aged < 18 years; 31-49 years or > 65 years
- Body mass index < 18.5 or > 30 kg/m2
- Current smoker
- Fasting blood cholesterol or glucose concentrations outside the normal concentration range
- Diagnosed chronic illness (for example diagnosed cardiovascular disease, diabetes, cancer)
- Use of prescribed medicine to control inflammation
Show all 12Show fewer
- Use of prescribed medication to control blood lipids (e.g. statins, fibrates (fenofibrate), Omacor)
- Use of prescribed medication to control blood pressure (ACE inhibitors, angiotensin 2 receptor blockers, calcium channel blockers, α-inhibitors, thiazide diuretics)
- Use of fish oil or other oil supplements
- Chronic gastrointestinal problems (e.g. IBD, coeliac disease, cancer)
- Pregnant or planning to become pregnant within the study period
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Medicine, University of Southampton
Southampton, Hants, SO16 6YD
About this study
Official title: Can Oils Derived From Genetically-modified Plants Replace Fish Oil as a Source of Long Chain n-3 Polyunsaturated Fatty Acids in the Human Diet
Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be beneficial to health. Many people consume little, despite UK government recommendations to eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish stocks are declining due to over fishing. Therefore, there is a need for an alternative, sustainable and cost efficiently produced dietary source. A seed oil source of these fish oil-type fatty acids has been achieved by adding genes from other plant sources to the oil seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided seed oil for human consumption for thousands of years. It was the most important oil seed plant in Europe until the 1900's. This research is being done to see if consuming fish oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil fatty acids in the same way as it does from fish oil.
Read the detailed description
This research is being done to see if consuming fish oil-type omega 3 long chain polyunsaturated fatty acids in Camelina seed oil allows the body to take up the fish oil fatty acids in the same way as it does from fish oil.
In the first study (A) the Camelina oil will be used in a meal. The volunteers (healthy men and women) will be asked to consume the meal and provide blood samples in the following 6 hours to look at immediate uptake of the fish oil fatty acids. This will be repeated (for comparison) with fish oil.
The second study (B) will look at consumption over a longer period. Volunteers will be asked to consume the Camelina oil daily for 8 weeks and provide blood samples at the visits at the start and end of that period. This will be repeated (for comparison) with fish oil.
- Conditions
- Healthy
- Being tested
- Single dose fish oil, Repeated dose fish oil, single dose Camelina seed oil, repeated dose camelina seed oil
- Keywords
- omega 3 polyunsaturated fatty acid, camelina sativa, fatty acid composition, immune modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose fish oilDietary supplement
Fish oil consumed within a single high fat test meal
Repeated dose fish oilDietary supplement
Fish oil consumed daily for 8 weeks
single dose Camelina seed oilDietary supplement
camelina seed oil consumed within a single high fat test meal
repeated dose camelina seed oilDietary supplement
camelina seed oil consumed daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Active comparator | Fish oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose Receives: Dietary Supplement: Single dose fish oil; Dietary Supplement: single dose Camelina seed oil |
| Camelina seed oil | Experimental | Camelina seed oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose Receives: Dietary Supplement: Repeated dose fish oil; Dietary Supplement: repeated dose camelina seed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of omega 3 polyunsaturated fatty acids after short term consumption of fish oil or Camelina seed oil.
The magnitude of the increase in omega 3 polyunsaturated fatty acids in plasma lipids and blood cells following consumption of modified Camelina seed oil for short (postprandial) period compared with fish oil.
Measured: Short term consumption - single dose followed over 8 hours
Uptake of omega 3 polyunsaturated fatty acids after longer term consumption of fish oil or Camelina seed oil.
The magnitude of the increase in omega 3 polyunsaturated fatty acids in plasma lipids and blood cells following consumption of modified Camelina seed oil for 8 weeks compared with fish oil.
Measured: Longer term consumption daily for 8 weeks. Follow up at 8 weeks.
Secondary outcomes (2)
Effect of omega 3 polyunsaturated fatty acid consumption on postprandial inflammatory markers after consumption of fish oil or Camelina seed oil.
To measure the appearance of inflammatory mediators in the blood of healthy subjects over 8 hours following consumption of a standard high fat meal containing modified Camelina seed oil compared with consuming the same meal containing fish oil.
Measured: Short term consumption - single dose followed over 8 hours
Effect of omega 3 polyunsaturated fatty acid consumption for 8 weeks on in vitro immune responses after consumption of fish oil or Camelina seed oil.
To measure in vitro immune responses (immune cells inflammatory markers and response to bacterial challenge) by peripheral blood mononuclear cells following consumption of modified Camelina seed oil for 8 weeks compared with consuming fish oil for the same duration.
Measured: Longer term consumption daily for 8 weeks. Follow up at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start9 Jun 2017
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graham C Burdge, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477045
- Sponsor's protocol ID
- 17497
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2018
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
West AL, Michaelson LV, Miles EA, Haslam RP, Lillycrop KA, Georgescu R, Han L, Sayanova O, Napier JA, Calder PC, Burdge GC. Differential postprandial incorporation of 20:5n-3 and 22:6n-3 into individual plasma triacylglycerol and phosphatidylcholine molecular species in humans. Biochim Biophys Acta Mol Cell Biol Lipids. 2020 Aug;1865(8):158710. doi: 10.1016/j.bbalip.2020.158710. Epub 2020 Apr 11.
PubMed 32289503West AL, Miles EA, Lillycrop KA, Han L, Napier JA, Calder PC, Burdge GC. Dietary supplementation with seed oil from transgenic Camelina sativa induces similar increments in plasma and erythrocyte DHA and EPA to fish oil in healthy humans. Br J Nutr. 2020 Nov 14;124(9):922-930. doi: 10.1017/S0007114520002044. Epub 2020 Jun 9.
PubMed 32513312West AL, Michaelson LV, Miles EA, Haslam RP, Lillycrop KA, Georgescu R, Han L, Napier JA, Calder PC, Burdge GC. Lipidomic Analysis of Plasma from Healthy Men and Women Shows Phospholipid Class and Molecular Species Differences between Sexes. Lipids. 2021 Mar;56(2):229-242. doi: 10.1002/lipd.12293. Epub 2020 Dec 7.
PubMed 33284478West AL, Miles EA, Lillycrop KA, Napier JA, Calder PC, Burdge GC. Genetically modified plants are an alternative to oily fish for providing n-3 polyunsaturated fatty acids in the human diet: A summary of the findings of a Biotechnology and Biological Sciences Research Council funded project. Nutr Bull. 2021 Mar;46(1):60-68. doi: 10.1111/nbu.12478. Epub 2020 Dec 23.
PubMed 33776584
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Oils Derived From Genetically-modified Plants Replace Fish Oil as a Source of Long Chain n-3 Polyunsaturated Fatty Acids in the Human Diet
- ClinicalTrials.gov ID
- NCT03477045
- Acronym / sponsor ID
- 17497
- Conditions
- Healthy
- Keywords
- omega 3 polyunsaturated fatty acid, camelina sativa, fatty acid composition, immune modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 26 Mar 2018 (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.
Fish oil and oily fish contain omega 3 long chain polyunsaturated fatty acids known to be beneficial to health. Many people consume little, despite UK government recommendations to eat at least one portion of oily fish per week. Furthermore, despite modest consumption, fish stocks are declining due to over fishing. Therefore, there is a need for an alternative, sustainable and cost efficiently produced dietary source. A seed oil source of these fish oil-type fatty acids has been achieved by adding genes from other plant sources to the oil seed plant Camelina sativa. Camelina sativa, related to mustard and cabbage, has provided seed oil for human consumption for thousands of years. It was the most important oil seed plant in Europe until the 1900's. This research is being done to see if consuming fish oil-type fatty acids in Camelina seed oil allows the body to take up and use the fish oil fatty acids in the same way as it does from fish oil.
Detailed description
This research is being done to see if consuming fish oil-type omega 3 long chain polyunsaturated fatty acids in Camelina seed oil allows the body to take up the fish oil fatty acids in the same way as it does from fish oil.
In the first study (A) the Camelina oil will be used in a meal. The volunteers (healthy men and women) will be asked to consume the meal and provide blood samples in the following 6 hours to look at immediate uptake of the fish oil fatty acids. This will be repeated (for comparison) with fish oil.
The second study (B) will look at consumption over a longer period. Volunteers will be asked to consume the Camelina oil daily for 8 weeks and provide blood samples at the visits at the start and end of that period. This will be repeated (for comparison) with fish oil.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Active comparator | Dietary Supplement: Single dose fish oil, Dietary Supplement: single dose Camelina seed oilFish oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose |
| Camelina seed oil | Experimental | Dietary Supplement: Repeated dose fish oil, Dietary Supplement: repeated dose camelina seed oilCamelina seed oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female
- 18 to 30 years or 50 to 65 years
- Body mass index 18.5-30.0 kg/m2
- Health screening results that are within normal clinical ranges
- Not consuming fish oil or other oil supplements
Key exclusion criteria (12 listed)
- Aged < 18 years; 31-49 years or > 65 years
- Body mass index < 18.5 or > 30 kg/m2
- Current smoker
- Fasting blood cholesterol or glucose concentrations outside the normal concentration range
- Diagnosed chronic illness (for example diagnosed cardiovascular disease, diabetes, cancer)
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 |
|---|---|---|
| Single dose fish oilFish oil consumed within a single high fat test meal | Dietary supplement | Fish oil |
| Repeated dose fish oilFish oil consumed daily for 8 weeks | Dietary supplement | Camelina seed oil |
| single dose Camelina seed oilcamelina seed oil consumed within a single high fat test meal | Dietary supplement | Fish oil |
| repeated dose camelina seed oilcamelina seed oil consumed daily for 8 weeks | Dietary supplement | Camelina seed oil |
Primary outcome
Uptake of omega 3 polyunsaturated fatty acids after short term consumption of fish oil or Camelina seed oil.
Time frame: Short term consumption - single dose followed over 8 hours
The magnitude of the increase in omega 3 polyunsaturated fatty acids in plasma lipids and blood cells following consumption of modified Camelina seed oil for short (postprandial) period compared with fish oil.
Uptake of omega 3 polyunsaturated fatty acids after longer term consumption of fish oil or Camelina seed oil.
Time frame: Longer term consumption daily for 8 weeks. Follow up at 8 weeks.
The magnitude of the increase in omega 3 polyunsaturated fatty acids in plasma lipids and blood cells following consumption of modified Camelina seed oil for 8 weeks compared with fish oil.
2 secondary outcomes
Effect of omega 3 polyunsaturated fatty acid consumption on postprandial inflammatory markers after consumption of fish oil or Camelina seed oil.
Time frame: Short term consumption - single dose followed over 8 hours
Effect of omega 3 polyunsaturated fatty acid consumption for 8 weeks on in vitro immune responses after consumption of fish oil or Camelina seed oil.
Time frame: Longer term consumption daily for 8 weeks. Follow up at 8 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 15 Jun 2022.
- Results publication: PubMed 32289503West AL, Michaelson LV, Miles EA, Haslam RP, Lillycrop KA, Georgescu R, Han L, Sayanova O, Napier JA, Calder PC, Burdge GC. Differential postprandial incorporation of 20:5n-3 and 22:6n-3 into individual plasma triacylglycerol and phosphatidylcholine molecular species in humans. Biochim Biophys Acta Mol Cell Biol Lipids. 2020 Aug;1865(8):158710. doi: 10.1016/j.bbalip.2020.158710. Epub 2020 Apr 11.
- Results publication: PubMed 32513312West AL, Miles EA, Lillycrop KA, Han L, Napier JA, Calder PC, Burdge GC. Dietary supplementation with seed oil from transgenic Camelina sativa induces similar increments in plasma and erythrocyte DHA and EPA to fish oil in healthy humans. Br J Nutr. 2020 Nov 14;124(9):922-930. doi: 10.1017/S0007114520002044. Epub 2020 Jun 9.
- Results publication: PubMed 33284478West AL, Michaelson LV, Miles EA, Haslam RP, Lillycrop KA, Georgescu R, Han L, Napier JA, Calder PC, Burdge GC. Lipidomic Analysis of Plasma from Healthy Men and Women Shows Phospholipid Class and Molecular Species Differences between Sexes. Lipids. 2021 Mar;56(2):229-242. doi: 10.1002/lipd.12293. Epub 2020 Dec 7.
- Results publication: PubMed 33776584West AL, Miles EA, Lillycrop KA, Napier JA, Calder PC, Burdge GC. Genetically modified plants are an alternative to oily fish for providing n-3 polyunsaturated fatty acids in the human diet: A summary of the findings of a Biotechnology and Biological Sciences Research Council funded project. Nutr Bull. 2021 Mar;46(1):60-68. doi: 10.1111/nbu.12478. Epub 2020 Dec 23.
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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.
Graham C Burdge, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single dose fish oil, Repeated dose fish oil and single dose Camelina seed oil in people with Healthy, run by University of Southampton at 1 site 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 8 inclusion and 12 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Uptake of omega 3 polyunsaturated fatty acids after short term consumption of fish oil or Camelina seed oil. (time frame: Short term consumption - single dose followed over 8 hours). The study lists 2 primary outcomes in all. 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 NCT03477045, 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 15 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.