Impacts of Omega-3-PUFA Enriched Chicken-meat and Eggs in Healthy Humans
A Study of the Absorption, Distribution and Cardiovascular Benefits for Humans of Eating Chicken-meat and Eggs Enriched With Omega-3 PUFAs Over a 6-month Period
1 other identifier
interventional
160
1 country
1
Brief Summary
Eating oily fish containing long chain seafood-derived omega-3 polyunsaturated fatty acids (PUFAs) protects against heart attacks and strokes. Hence most national and international guidelines now recommend that adults eat at least 2 servings per week of oily fish. However uptake of these recommendations is poor - many people do not eat seafood at all. A number of factors probably contribute to this poor compliance with guidelines; limited availability and costs of oily fish; distaste for oily fish; and concern about toxins in such fish. An Irish company, Devenish Nutrition, offers a possible alternative solution - by feeding omega-3 PUFA-enriched feeds to chicken, Devenish Nutrition have demonstrated that the resultant chicken meat and eggs are enriched in omega-3 PUFAs. A recently completed small study, with 30 participants, showed that 5 weeks of eating omega-3 PUFA enriched chicken resulted in increased blood levels of omega-3 PUFAs. There were also beneficial effects on blood pressure and on platelet stickiness. This study will be larger (including 160 participants) and longer in duration (6 months). It will be a double-blind, controlled, randomized study. This will allow testing whether eating omega-3 PUFA enriched chicken-meat regularly over a 6 month period, results in even greater increments in blood levels of omega-3 PUFAs, and in greater beneficial effects on cardiovascular risk factors. Beneficial effects of eating omega-3 PUFA enriched eggs will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2018
CompletedFirst Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedNovember 14, 2023
November 1, 2023
3.6 years
October 6, 2019
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Red Cell Omega-3 Index
Sum of EPA and DHA expressed as percentage of total fatty acids in erythrocyte membranes
6 months
Secondary Outcomes (15)
Red Cell Omega-3 Index
3 months
Plasma levels of EPA and DHA
3 and 6 months
Systolic blood pressure
3 and 6 months
Diastolic blood pressure
3 and 6 months
Heart rate
3 and 6 months
- +10 more secondary outcomes
Study Arms (4)
Control Chicken-meat & Control Eggs
PLACEBO COMPARATORParticipants will be provided with control chicken-meat and control eggs, and will be requested to eat at least three portions/week of the control chicken-meat, and to eat at least three control eggs/week, for 6 months.
Control Chicken-meat & Omega-3 Eggs
EXPERIMENTALParticipants will be provided with control chicken-meat and omega-3-PUFA enriched eggs, and will be requested to eat at least three portions/week of the control chicken-meat, and to eat at least three omega-3-enriched eggs/week, for 6 months.
Omega-3 Chicken-meat & Control Eggs
EXPERIMENTALParticipants will be provided with omega-3-PUFA enriched chicken-meat and control eggs, and will be requested to eat at least three portions/week of the omega-3-PUFA enriched chicken-meat, and to eat at least three control eggs/week, for 6 months.
Omega-3 Chicken-meat & Omega-3 Eggs
EXPERIMENTALParticipants will be provided with omega-3-PUFA enriched chicken-meat and omega-3-PUFA enriched eggs, and will be requested to eat at least three portions/week of the omega-3-PUFA enriched chicken-meat, and to eat at least three omega-3-PUFA enriched eggs/week, for 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Adults (≥ 18 years)
- Able to give informed consent
You may not qualify if:
- Previous diagnosis of significant cardiovascular disease (myocardial infarction, coronary intervention, or stroke).
- Currently prescribed anti-hypertensive, lipid lowering, anti-platelet therapy or non-steroidal anti-inflammatory drugs.
- Discovery of sustained hypertension (Daytime BP average \> 140/90), and/or significant dyslipidaemia (Fasting LDL Cholesterol \> 4mmol/l or Triglycerides \> 4mmol/) at the baseline assessments.
- Currently regularly taking Omega-3 PUFA supplements.
- Any known, unresolved history of drug use or alcohol dependency, lack of ability to comprehend or follow instructions, or unlikely or unable to comply with study follow-up requirements
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alice Stantonlead
- Devenish Nutrition, Belfast, United Kingdom.collaborator
- Beaumont Hospitalcollaborator
- University College Dublincollaborator
Study Sites (1)
Royal College of Surgeons at Beaumont Hospital
Dublin, Ireland
Study Officials
- PRINCIPAL INVESTIGATOR
Alice V Stanton, MB PhD
Royal College of Surgeons in Ireland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomisation and masking The randomisation schedule was computer generated. Separate sealed opaque envelopes were prepared for male and female participants. All investigators involved in participant recruitment, data collection and entry, sample collection, processing and analysis, will be masked to the randomisation groups until data entry is completed and the database is locked.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Cardiovascular Therapeutics
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 15, 2019
Study Start
February 1, 2015
Primary Completion
August 27, 2018
Study Completion
June 30, 2020
Last Updated
November 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- 6 months after the primary results have been published
- Access Criteria
- Formal request from qualified scientific and medical researchers will be considered. Access must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent
All de-identified individual participant data that underlie the results in a publication, and applicable supporting clinical trial documents, may be available upon request.