Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?
NCT ID: NCT03477045
Last Updated: 2022-06-15
Study Results
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Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2017-06-09
2019-11-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Fish oil
Fish oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose
Single dose fish oil
Fish oil consumed within a single high fat test meal
single dose Camelina seed oil
camelina seed oil consumed within a single high fat test meal
Camelina seed oil
Camelina seed oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose
Repeated dose fish oil
Fish oil consumed daily for 8 weeks
repeated dose camelina seed oil
camelina seed oil consumed daily for 8 weeks
Interventions
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Single dose fish oil
Fish oil consumed within a single high fat test meal
Repeated dose fish oil
Fish oil consumed daily for 8 weeks
single dose Camelina seed oil
camelina seed oil consumed within a single high fat test meal
repeated dose camelina seed oil
camelina seed oil consumed daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
2. 18 to 30 years or 50 to 65 years
3. Body mass index 18.5-30.0 kg/m2
4. Health screening results that are within normal clinical ranges
5. Not consuming fish oil or other oil supplements
6. Not eating more than one oily fish meal per week
7. Willing to adhere to the study protocol
8. Being able to provide written informed consent
Exclusion Criteria
2. Body mass index \< 18.5 or \> 30 kg/m2
3. Current smoker
4. Fasting blood cholesterol or glucose concentrations outside the normal concentration range
5. Diagnosed chronic illness (for example diagnosed cardiovascular disease, diabetes, cancer)
6. Use of prescribed medicine to control inflammation
7. Use of prescribed medication to control blood lipids (e.g. statins, fibrates (fenofibrate), Omacor)
8. Use of prescribed medication to control blood pressure (ACE inhibitors, angiotensin 2 receptor blockers, calcium channel blockers, α-inhibitors, thiazide diuretics)
9. Use of fish oil or other oil supplements
10. Chronic gastrointestinal problems (e.g. IBD, coeliac disease, cancer)
11. Pregnant or planning to become pregnant within the study period
12. Participation in another clinical trial
18 Years
65 Years
ALL
Yes
Sponsors
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University of Southampton
OTHER
Responsible Party
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Principal Investigators
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Graham C Burdge, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southampton
Locations
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Faculty of Medicine, University of Southampton
Southampton, Hants, United Kingdom
Countries
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References
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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.
West 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.
West 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.
West 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17497
Identifier Type: -
Identifier Source: org_study_id
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