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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259825 on ClinicalTrials.gov