Cardiometabolic Health
Conditions
Keywords
fish, sea bream, dietary intervention, olive oil, platelet aggregation, thrombosis, inflammation, cardioprotection
Brief 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.
Interventions
BEHAVIORALConventional fish
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.
BEHAVIORALEnriched fish
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.
Sponsors
Nireus Aquaculture
National and Kapodistrian University of Athens
Harokopio University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 30-65 years old * Body Mass Index between 24-31 kg/m\^2 * Habitual fish consumption: \<150 g of cooked fish per week
Exclusion criteria
* Pregnancy * Current or recent weight loss effort * Use of dietary supplements * Being under treatment for any medical disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks | 0 (baseline) and 8 weeks | Efficiency concentration fifty of adenosine diphosphate-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry |
| Change from baseline of platelet activating factor-induced platelet aggregation at 8 weeks | 0 (baseline) and 8 weeks | Efficiency concentration fifty of platelet activating factor-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry |
| Change from baseline of thrombin-induced platelet aggregation at 8 weeks | 0 (baseline) and 8 weeks | Efficiency concentration fifty of thrombin-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry |
| Change from baseline in of plasminogen activator inhibitor-1 activity at 8 weeks | 0 (baseline) and 8 weeks | Plasminogen activator inhibitor-1 activity (mAU/mL) will be measured in blood samples using commercially available ELISA kits |
| Change from baseline in soluble P-selectin levels at 8 weeks | 0 (baseline) and 8 weeks | Soluble P-selectin levels (ng/mL) will be measured in blood samples using commercially available ELISA kits |
Countries
Greece
Outcome results
None listed