Effect of Differently Fed Farmed Gilthead Sea Bream Consumption
Condition: Cardiometabolic Health
Study type: Interventional

Summary: 
      The trial was a double-blind randomized dietary intervention study with a 1:1 allocation
      ratio, conducted in accordance with the Declaration of Helsinki. This study compared two
      treatments, i.e., farmed fish fed with olive pomace enriched diet (enriched fish; EF) versus
      farmed fish fed with fish oil diet (conventional fish; CF), using a crossover design. The
      study lasted 22 weeks; treatment period one (8 weeks, mid-January-end of March), washout
      period (6 weeks), and treatment period two (8 weeks, mid-May-end of July). The participants
      were equally distributed to the two treatments along treatment periods. Eligible subjects
      were all adults aged between 30 and 65 years old with a body mass index (BMI) between 24.0
      and 31.0 kg/m2 who met the eligibility criteria for habitual fish consumption (<150 g of
      cooked fish per week). Exclusion criteria were pregnancy, current or recent weight loss
      effort, use of dietary supplements and being under treatment for any medical disorder.
      Subjects were allowed to use medical treatment for thyroid gland disorders, iron or folic
      acid supplements, contraceptives or hormone replacement therapy (HRT) for women, provided
      they would continue receiving their medication throughout the study. The aim of the study was
      to evaluate the effects of consumption of fillets from differently fed farmed gilthead sea
      bream on markers of cardiometabolic health such as platelet aggregation, circulating
      haemostatic markers, markers of inflammation and oxidative stress.
    


Intervention name(s): Conventional fish; Enriched fish
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants initially randomized to this intervention arm will be provided with conventional sea bream fillets and will be asked to consume them twice weekly for 8 weeks. Conventional sea bream fillets will be produced by a fish farming company using standard procedures. Participants will also be instructed to keep the reception of prescribed medications and dietary supplements stable and not to change their lifestyle habits (e.g. other dietary habits besides fish consumption, physical activity habits or sleep habits) during the intervention. After a 6-week wash-out period (no fish consumption), participants will cross over to the other intervention arm.; Participants initially randomized to this intervention arm will be provided with conventional sea bream fillets and will be asked to consume them twice weekly for 8 weeks. Conventional sea bream fillets will be produced by a fish farming company using a diet enriched with olive pomace. Participants will also be instructed to keep the reception of prescribed medications and dietary supplements stable and not to change their lifestyle habits (e.g. other dietary habits besides fish consumption, physical activity habits or sleep habits) during the intervention. After a 6-week wash-out period (no fish consumption), participants will cross over to the other intervention arm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fish; sea bream; dietary intervention; olive oil; platelet aggregation; thrombosis; inflammation; cardioprotection