Clinical trial NCT03477045: Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: omega 3 polyunsaturated fatty acid
camelina sativa
fatty acid composition
immune modulation
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female
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:

1. Aged \< 18 years; 31-49 years or \> 65 years
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

Primary outcomes:
measure: Uptake of omega 3 polyunsaturated fatty acids after short term consumption of fish oil or Camelina seed oil.
timeFrame: Short term consumption - single dose followed over 8 hours
measure: Uptake of omega 3 polyunsaturated fatty acids after longer term consumption of fish oil or Camelina seed oil.
timeFrame: Longer term consumption daily for 8 weeks. Follow up at 8 weeks.
Secondary outcomes:
measure: Effect of omega 3 polyunsaturated fatty acid consumption on postprandial inflammatory markers after consumption of fish oil or Camelina seed oil.
timeFrame: Short term consumption - single dose followed over 8 hours
measure: 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.
timeFrame: Longer term consumption daily for 8 weeks. Follow up at 8 weeks.
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Faculty of Medicine, University of Southampton
state: Hants
Study officials:
affiliation: University of Southampton
name: Graham C Burdge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.