Cardioprotective Properties of ELAIOTSIPOURA

NCT04440202 | Completed

• 1 other identifier: 71777/13-2-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fish; sea bream; dietary intervention; olive oil; polar lipids; platelet aggregation; thrombosis; inflammation; cardioprotection

Outcome Measures

Primary Outcomes (4)

• Change from baseline of adenosine diphosphate-induced platelet aggregation at 4 weeks

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

  0 (baseline) and 4 weeks

• Change from baseline of platelet activating factor-induced platelet aggregation at 4 weeks

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

  0 (baseline) and 4 weeks

• Change from baseline in tissue plasminogen activator activity at 4 weeks

  Tissue plasminogen activator activity (mIU/mL) will be measured in blood samples using commercially available ELISA kits

  0 (baseline) and 4 weeks

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

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

  0 (baseline) and 4 weeks

Secondary Outcomes (3)

• Change from baseline in high sensitivity interleukin-6 levels at 4 weeks

  0 (baseline) and 4 weeks

• Change from baseline in high sensitivity interleukin-10 levels at 4 weeks

  0 (baseline) and 4 weeks

• Change from baseline in soluble P-selectin levels at 4 weeks

  0 (baseline) and 4 weeks

Study Arms (2)

Conventional sea bream group

ACTIVE COMPARATOR

This arm will consume 2 portions (each 200 g cooked) of conventional fish (sea bream) fillet per week for a 1-month period.

Behavioral: Conventional sea bream

Enriched sea bream group

EXPERIMENTAL

This arm will consume 2 portions (each 200 g cooked) of fish fillet bred with bioactive lipids from olive oil by-products per week for a 1-month period.

Behavioral: Enriched sea bream

Interventions

Conventional sea bream BEHAVIORAL

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.

Conventional sea bream group

Enriched sea bream BEHAVIORAL

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.

Enriched sea bream group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 35-70 years old
• Body mass index 25-35 kg/m2
• Habitual fish consumption ≤1 portion/week (1 portion: 150 g cooked fish)

You may not qualify if:

• Presence of diabetes mellitus, active cancer, cardiovascular disease, chronic inflammatory or psychiatric diseases
• Reception of antidiabetic, anxiolytic, antidepressant or cortisol medication
• Habitual excessive alcohol intake (\>210 g of ethanol/week for men and \>140 g of ethanol/week for women)
• Currently on a weight-loss diet or recent change (within 6 months) in lifestyle habits

Sponsors & Collaborators

• Harokopio University: lead
• Nireus Aquaculture: collaborator
• University of Thessaly: collaborator
• Cretan Herbalchem S.A.: collaborator
• National and Kapodistrian University of Athens: collaborator
• European Regional Development Fund (project code: T1EDK- 00687): collaborator

Study Sites (1)

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

Kallithea, Attica, 17671, Greece

Location

Related Publications (2)

• Antonopoulou S, Fragopoulou E, Karantonis HC, Mitsou E, Sitara M, Rementzis J, Mourelatos A, Ginis A, Phenekos C. Effect of traditional Greek Mediterranean meals on platelet aggregation in normal subjects and in patients with type 2 diabetes mellitus. J Med Food. 2006 Fall;9(3):356-62. doi: 10.1089/jmf.2006.9.356.

  PMID: 17004898 BACKGROUND

• Karantonis HC, Fragopoulou E, Antonopoulou S, Rementzis J, Phenekos C, Demopoulos CA. Effect of fast-food Mediterranean-type diet on type 2 diabetics and healthy human subjects' platelet aggregation. Diabetes Res Clin Pract. 2006 Apr;72(1):33-41. doi: 10.1016/j.diabres.2005.09.003. Epub 2005 Oct 19.

  PMID: 16236380 BACKGROUND

MeSH Terms

Conditions

Thrombosis; Inflammation

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Smaragdi Antonopoulou, PhD

  Department of Nutrition and Dietetics, Harokopio University

  PRINCIPAL INVESTIGATOR

• Tzortzis Nomikos, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

• Elizabeth Fragopoulou, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

• Meropi D Kontogianni, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

• Michael Georgoulis, PhD

  Department of Nutrition and Dietetics, Harokopio University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Biochemistry

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: October 18, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: July 5, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)