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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Single dose fish oil
* Dietary Supplement: Repeated dose fish oil
* Dietary Supplement: single dose Camelina seed oil
* Dietary Supplement: repeated dose camelina seed oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil<br>Fish oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose | Dietary Supplement: Single dose fish oil<br>* Fish oil consumed within a single high fat test meal<br>Dietary Supplement: single dose Camelina seed oil<br>* camelina seed oil consumed within a single high fat test meal<br>|
| Experimental: Camelina seed oil<br>Camelina seed oil providing 450 mg of eicosapentaenoic acid plus docosahexaenoic acid per dose | Dietary Supplement: Repeated dose fish oil<br>* Fish oil consumed daily for 8 weeks<br>Dietary Supplement: repeated dose camelina seed oil<br>* camelina seed oil consumed daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Longer term consumption daily for 8 weeks. Follow up at 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega 3 polyunsaturated fatty acid, camelina sativa, fatty acid composition, immune modulation