Does Consuming Modified Plant Seed Oil Containing Fish Oil Fatty Acids Act in the Same Way as Consuming Fish Oil?

NCT03477045 | Completed

• 1 other identifier: 17497
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

omega 3 polyunsaturated fatty acid; camelina sativa; fatty acid composition; immune modulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

  Longer term consumption daily for 8 weeks. Follow up at 8 weeks.

Study Arms (2)

Fish oil

ACTIVE COMPARATOR

Fish oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose

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

Dietary Supplement: Repeated dose fish oil; Dietary Supplement: repeated dose camelina seed oil

Interventions

Single dose fish oil DIETARY_SUPPLEMENT

Fish oil consumed within a single high fat test meal

Fish oil

Repeated dose fish oil DIETARY_SUPPLEMENT

Fish oil consumed daily for 8 weeks

Camelina seed oil

single dose Camelina seed oil DIETARY_SUPPLEMENT

camelina seed oil consumed within a single high fat test meal

Fish oil

repeated dose camelina seed oil DIETARY_SUPPLEMENT

camelina seed oil consumed daily for 8 weeks

Camelina seed oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

Faculty of Medicine, University of Southampton

Southampton, Hants, SO16 6YD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 32289503 RESULT

• 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.

  PMID: 32513312 RESULT

• 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.

  PMID: 33284478 RESULT

• 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.

  PMID: 33776584 RESULT

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Graham C Burdge, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 26, 2018
• Study Start: June 9, 2017
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

GB (1)