Omega-3-Index Response to Eating Poultry Foods Naturally Enriched With Omega-3 Polyunsaturated Fatty Acids
Status: Not yet recruiting

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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (≥ 18 years and < 70 years) Regular consumers (≥ 4 portions weekly) or willing to be regular consumers of chicken-meat. Regular consumers (≥ 4 eggs weekly) or willing to be regular consumers of eggs. Able to give informed consent.  Exclusion Criteria:  Concurrent or recent (within last 3 months) regular intake of long-chain omega-3-PUFA supplements (containing EPA, DPA and/or DHA).  Previous diagnosis of;  significant cardiovascular disease (e.g. myocardial infarction, coronary intervention, or stroke), significant mental ill-health (e.g. major depression, psychosis or dementia) or a haemoglobinopathy such as sickle cell anaemia or thalassemia . Any other 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. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult