Cardioprotective Properties of ELAIOTSIPOURA

Summary

Several studies over the last decades have demonstrated the important role of nutrition for either the prevention of chronic diseases, such as cardiovascular disease and cancer, or the increase of their risk. One dietary component with several health benefits as supported by several epidemiological and clinical studies is fish consumption. Both the European Society of Cardiology and the American Heart Association recommend the consumption of at least two servings of fish per week for protection against cardiovascular disease. Nevertheless, the growth of the human population and the rising consumers' awareness, result in a constantly increasing demand for the supply of fish. Aquaculture is significantly contributing to fish supplies all over the world and over the past few years, important breakthroughs have occurred in the replacement of fish oil, traditionally used in aquacultures, by plant oils in compounded fish feeds as a mean to improve the nutritional value of the produced fish. Under this perspective, the utilization of olive oil by-products, widely available in the Mediterranean countries, in fish feeds could result in significant economic and environmental impact. Therefore, the aim of the present double-blind, randomized, crossover clinical trial is to explore the potential cardioprotective properties of "elaiotsipoura", a novel sea bream fed with bioactive lipids isolated from olive oil by-products, against conventionally fed sea bream, in apparently healthy volunteers.

Conditions

• Cardiometabolic Health

Interventions

BEHAVIORAL

Conventional sea bream

Participants initially randomized to this intervention arm will be provided with a total of 8 conventional sea bream fillets and will be asked to consume them twice weekly for 1 month. 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 1-month wash-out period (no fish consumption), participants will cross over to the other intervention arm.

BEHAVIORAL

Enriched sea bream

Participants initially randomized to this intervention arm will be provided with a total of 8 enriched sea bream fillets and will be asked to consume them twice weekly for 1 month. Enriched sea bream fillets will be produced by a fish farming company from fish bread with a diet enriched with a fraction of bioactive polar lipids extracted from olive oil by-products. 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 1-month wash-out period (no fish consumption), participants will cross over to the other intervention arm.

Sponsors & Collaborators

• Nireus Aquaculture

  collaborator UNKNOWN

• University of Thessaly

  collaborator OTHER

• Cretan Herbalchem S.A.

  collaborator UNKNOWN

• National and Kapodistrian University of Athens

  collaborator OTHER

• European Regional Development Fund (project code: T1EDK- 00687)

  collaborator UNKNOWN

• Harokopio University

  lead OTHER

Principal Investigators

• Smaragdi Antonopoulou, PhD · Department of Nutrition and Dietetics, Harokopio University

• Tzortzis Nomikos, PhD · Department of Nutrition and Dietetics, Harokopio University

• Elizabeth Fragopoulou, PhD · Department of Nutrition and Dietetics, Harokopio University

• Meropi D Kontogianni, PhD · Department of Nutrition and Dietetics, Harokopio University

• Michael Georgoulis, PhD · Department of Nutrition and Dietetics, Harokopio University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-18

Primary Completion

2022-07-30

Completion

2022-07-30

Countries

• Greece

Study Locations