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Completed

NCT Number: NCT03477045

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, University of Southampton

Southampton, Hants, SO16 6YD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Single dose fish oil

Dietary Supplement

Fish oil consumed within a single high fat test meal

Repeated dose fish oil

Dietary Supplement

Fish oil consumed daily for 8 weeks

single dose Camelina seed oil

Dietary Supplement

camelina seed oil consumed within a single high fat test meal

repeated dose camelina seed oil

Dietary Supplement

camelina seed oil consumed daily for 8 weeks

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2018
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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