Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04440202
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2020-06-17
Brief Title:
Cardioprotective Properties of ELAIOTSIPOURA
Sponsor:
Harokopio University
Organization:
Harokopio University
Study Overview
Official Title:
Cardioprotective Properties of Sea Bream Bred With a Fraction of Polar Lipids Extracted From Olive Oil By-products the ELAIOTSIPOURA Study
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Cardiovascular diseases CVD represent a major public health challenge and the leading cause of mortality worldwide The elucidation of CVD pathogenesis as well as the identification of efficient strategies for their prevention and treatment have been the subject of intense research in recent years The platelet activation factor PAF is one of the most important mediators of atherosclerosis given that it is produced by cells involved in the formation of atherosclerotic plaque eg endothelial cells platelets smooth muscle cells macrophages and neutrophils under conditions that predispose to CVD ie inflammation oxidative stress endothelial dysfunction and dyslipidaemia PAF acts on neighbouring cells by inducing a series of responses eg chemotaxis expression of adhesion molecules and accumulation of platelets that eventually lead to endothelial and atherosclerotic damage
The Mediterranean diet MD is a dietary pattern with well-established protective effects against the development of CVD Several foods representative of the MD such as honey wine and fish have been found to be rich in nutrients mainly of lipid nature that can act as PAF inhibitors Investigators have recently focused on olive oil from which a bioactive polar lipoid BPL fraction with strong PAF inhibitors was extracted The most important of these inhibitors were structurally classified and found to belong to the class of glycolipids This BPL fraction showed strong anti-atherogenic properties in hypercholesterolaemic rabbits stronger than those produced by the same amount of olive oil BPLs could therefore be a bioactive extract that could potentially be used as an additive in biofunctional foods or as a dietary supplement aiming at preventing atherosclerosis and CVD However olive oil cannot be systematically used as the source of such an extract since the large quantities of olive oil required to extract BPLs combined with its high price make olive oil an unsustainable raw material In this context olive oil by-products could be a more suitable alternative source and their extract has been found to be rich in phenolic compounds and to exert a similar inhibitory effect against PAF This alternative extract has already been tested in hypercholesterolaemic rabbits and was shown to significantly reduce the thickness of atherosclerotic lesions In addition it has already been used by Nireus Aquaculture for pilot fish farming
The aim of the present study is to evaluate the potential cardio-protective properties of an innovative fish bred with bioactive lipids derived from olive oil by-products
The study will be a randomized cross-over double blind clinical trial The study sample will consist of 30 apparently healthy volunteers aged 35-70 years with a body mass index of 25-35 kgm2 who will not be under certain types of medication namely antidiabetic anxiolytics antidepressants and cortisol Other prescribed medications and dietary supplements will be allowed provided that their reception will remain stable by participants throughout the trial Individuals with diabetes mellitus active cancer cardiovascular diseases chronic inflammatory diseases or psychiatric diseases as well as those on a weight-loss diet or with recent significant changes in their lifestyle habits will be excluded from the study Participants will consume 2 servings per week of either a conventional sea bream fillet or an enriched with bioactive lipids derived from olive oil by-products sea bream fillet serving size 200 g cooked fish for 4 weeks with a 4-week wash-out period between the two interventions The study physician will be on a weekly contact with each participant to systematically record potential side-effects and will be in charge of terminating the intervention if needed
Participants will be assessed in terms of lifestyle habits dietary and physical activity habits and blood samples will be collected both at the beginning and end of each intervention period a total of 4 assessments Dietary habits will be assessed through a validated for the Greek population food frequency questionnaire while physical activity level will be assessed through the Athens Physical Activity Questionnaire also validated in the Greek population Adherence to dietary intervention will be assessed through weekly self-monitoring diaries in which participants will record the exact day and quantity of fish they consumed Participants diastolic and systolic blood pressure will be measured by the study physician at the 4 assessments throughout the study All blood samples will be collected and analyzed in the Laboratories of Clinical Nutrition and of Biology Biochemistry Physiology and Microbiology of the Department of Nutrition and Dietetics of Harokopio University of Athens by experienced personnel The ability of the platelet-rich plasma PRP to be accumulated under the influence of PAF and adenosine diphosphate ADP will be assessed by calculating the corresponding efficiency concentration fifty EC50 values A priori statistical power analysis showed that 25 participants in each arm were required to achieve statistical power equal to 83 at 5 significance level of two-sided hypotheses that evaluated 1 standard deviation SD differences based on EC50 values of platelet aggregation induced by PAF In addition thrombosis markers oxidation and inflammation markers as well as glycemic and lipidemic profile parameters will be measured in participants blood and urine samples
The Mediterranean diet MD is a dietary pattern with well-established protective effects against the development of CVD Several foods representative of the MD such as honey wine and fish have been found to be rich in nutrients mainly of lipid nature that can act as PAF inhibitors Investigators have recently focused on olive oil from which a bioactive polar lipoid BPL fraction with strong PAF inhibitors was extracted The most important of these inhibitors were structurally classified and found to belong to the class of glycolipids This BPL fraction showed strong anti-atherogenic properties in hypercholesterolaemic rabbits stronger than those produced by the same amount of olive oil BPLs could therefore be a bioactive extract that could potentially be used as an additive in biofunctional foods or as a dietary supplement aiming at preventing atherosclerosis and CVD However olive oil cannot be systematically used as the source of such an extract since the large quantities of olive oil required to extract BPLs combined with its high price make olive oil an unsustainable raw material In this context olive oil by-products could be a more suitable alternative source and their extract has been found to be rich in phenolic compounds and to exert a similar inhibitory effect against PAF This alternative extract has already been tested in hypercholesterolaemic rabbits and was shown to significantly reduce the thickness of atherosclerotic lesions In addition it has already been used by Nireus Aquaculture for pilot fish farming
The aim of the present study is to evaluate the potential cardio-protective properties of an innovative fish bred with bioactive lipids derived from olive oil by-products
The study will be a randomized cross-over double blind clinical trial The study sample will consist of 30 apparently healthy volunteers aged 35-70 years with a body mass index of 25-35 kgm2 who will not be under certain types of medication namely antidiabetic anxiolytics antidepressants and cortisol Other prescribed medications and dietary supplements will be allowed provided that their reception will remain stable by participants throughout the trial Individuals with diabetes mellitus active cancer cardiovascular diseases chronic inflammatory diseases or psychiatric diseases as well as those on a weight-loss diet or with recent significant changes in their lifestyle habits will be excluded from the study Participants will consume 2 servings per week of either a conventional sea bream fillet or an enriched with bioactive lipids derived from olive oil by-products sea bream fillet serving size 200 g cooked fish for 4 weeks with a 4-week wash-out period between the two interventions The study physician will be on a weekly contact with each participant to systematically record potential side-effects and will be in charge of terminating the intervention if needed
Participants will be assessed in terms of lifestyle habits dietary and physical activity habits and blood samples will be collected both at the beginning and end of each intervention period a total of 4 assessments Dietary habits will be assessed through a validated for the Greek population food frequency questionnaire while physical activity level will be assessed through the Athens Physical Activity Questionnaire also validated in the Greek population Adherence to dietary intervention will be assessed through weekly self-monitoring diaries in which participants will record the exact day and quantity of fish they consumed Participants diastolic and systolic blood pressure will be measured by the study physician at the 4 assessments throughout the study All blood samples will be collected and analyzed in the Laboratories of Clinical Nutrition and of Biology Biochemistry Physiology and Microbiology of the Department of Nutrition and Dietetics of Harokopio University of Athens by experienced personnel The ability of the platelet-rich plasma PRP to be accumulated under the influence of PAF and adenosine diphosphate ADP will be assessed by calculating the corresponding efficiency concentration fifty EC50 values A priori statistical power analysis showed that 25 participants in each arm were required to achieve statistical power equal to 83 at 5 significance level of two-sided hypotheses that evaluated 1 standard deviation SD differences based on EC50 values of platelet aggregation induced by PAF In addition thrombosis markers oxidation and inflammation markers as well as glycemic and lipidemic profile parameters will be measured in participants blood and urine samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None