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

June 14, 2022 updated by: University of Southampton

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hants
      • Southampton, Hants, United Kingdom, SO16 6YD
        • Faculty of Medicine, University of Southampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Investigators

  • Principal Investigator: Graham C Burdge, PhD, University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2017

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

November 4, 2019

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17497

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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