Omega-3-Index Response to Eating Poultry Foods Naturally Enriched With Omega-3 Polyunsaturated Fatty Acids
NCT06259825 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-03-13
Summary
Diets low in seafood omega-3 polyunsaturated fatty acids (PUFAs) are very prevalent. Such diets have recently been ranked as the sixth most important dietary risk factor-1.5 million deaths and 33 million disability-adjusted life-years worldwide are attributable to this deficiency. Wild oily fish stocks are insufficient to feed the world's population, and levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in farmed fish have more than halved in the last 20 years.
The primary objective of this randomised, double-blinded, controlled nutritional trial will be to test if consumption of at least 4 servings of omega-3 PUFA-enriched chicken-meat and 4 enriched eggs per week, over a 4-month period, results in measurably higher blood levels of EPA and DHA in healthy Saudi adults.
This will be a randomised double-blind interventional study. Eighty adult male and female participants (age ≥ 18 years of age) will be asked to eat at least 4 portions of omega-3-PUFA enriched (or control) chicken-meat per week, and at least 4 omega-3-PUFA enriched (or control) eggs per week, for 4 months. Participants will be assessed at baseline and at monthly intervals for 4 months. Assessments at these visits will include; comprehensive lifestyle and medical history; food frequency questionnaire; 3 days food record; height, weight, waist and hip circumferences; blood sampling; participant well-being and adverse events. Measurement of plasma and red blood cell levels of EPA, DHA and Docosapentaenoic acid (DPA) will be performed at baseline and at study end using gas chromatography-mass spectroscopy.
The primary end point will be the change in red blood cell omega-3-index (sum of EPA and DHA expressed as percentage of total fatty acids in erythrocyte membranes) at 4 months. The nutritional trial will be analyzed on an intension to treat basis. Repeated measures ANOVA will be used to compare the two study groups. The study will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement.
Conditions
- Healthy Nutrition
- Healthy Adults
Interventions
- OTHER
-
Omega-3 polyunsaturated fatty acid, naturally enriched, poultry foods (chicken-meat and eggs)
At least four portions of omega-3 PUFA enriched chicken-meat (whole chickens, breasts, thighs and drums) and at least four omega-3 PUFA enriched eggs will be consumed weekly for 4 months. The poultry meat and eggs will be enriched by feeding chickens a complete feed which includes algae, which is a rich source of omega-3 PUFAs (OmegaPro, Humanitiv, Meath, Ireland).
- OTHER
-
Control poultry foods (chicken-meat and eggs)
At least four portions of standard chicken-meat (whole chickens, breasts, thighs and drums) and at least four standard eggs will be consumed weekly for 4 months.
Sponsors & Collaborators
-
Royal College of Surgeons, Ireland
collaborator OTHER -
University College Dublin
collaborator OTHER -
King Abdulaziz University
lead OTHER
Principal Investigators
-
Salwa Albar, BSc, PhD · King Abdulaziz University
-
Alice V Stanton, MB, PhD · Royal College of Surgeons in Ireland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-02-01
- Primary Completion
- 2024-10-31
- Completion
- 2024-10-31
Countries
- Saudi Arabia
Study Locations
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