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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477045
• Other study ID #: 17497
• Status: Completed
• Phase: N/A
• Start date: June 9, 2017
• Est. completion date: November 4, 2019

Study information

• Verified date: June 2022
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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, a-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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United Kingdom	Faculty of Medicine, University of Southampton	Southampton	Hants

Sponsors (1)

Lead Sponsor	Collaborator
University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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 — View 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 molec — View 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 — View 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 Scie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.