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Completed

NCT Number: NCT05417191

Effect of Differently Fed Farmed Gilthead Sea Bream Consumption

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.

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Key information

Conditions

Cardiometabolic Health Cardiovascular Diseases Embolism and Thrombosis Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University

Kallithea, Attica, 17671, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional fish

Behavioral

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.

Enriched fish

Behavioral

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.

Primary outcomes

  1. Change from baseline of adenosine diphosphate-induced platelet aggregation at 8 weeks

    Time frame: 0 (baseline) and 8 weeks

    Efficiency concentration fifty of adenosine diphosphate-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

  2. Change from baseline of platelet activating factor-induced platelet aggregation at 8 weeks

    Time frame: 0 (baseline) and 8 weeks

    Efficiency concentration fifty of platelet activating factor-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

  3. Change from baseline of thrombin-induced platelet aggregation at 8 weeks

    Time frame: 0 (baseline) and 8 weeks

    Efficiency concentration fifty of thrombin-induced platelet aggregation (microM) will be assessed by light transmittance aggregometry

  4. Change from baseline in of plasminogen activator inhibitor-1 activity at 8 weeks

    Time frame: 0 (baseline) and 8 weeks

    Plasminogen activator inhibitor-1 activity (mAU/mL) will be measured in blood samples using commercially available ELISA kits

  5. Change from baseline in soluble P-selectin levels at 8 weeks

    Time frame: 0 (baseline) and 8 weeks

    Soluble P-selectin levels (ng/mL) will be measured in blood samples using commercially available ELISA kits

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • National and Kapodistrian University of Athens
  • Nireus Aquaculture

Registry information

Official study title

Effect of Fish Consumption Enriched With Biologically Active Lipids From Olive Pomace, on Cardiovascular Risk Factors in Apparently Healthy Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 14, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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