In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids

University of Limerick6 enrolled

Overview

The aim of this project is to study the effects of a new-developed food-supplement that contains bioactive polar lipids derived from organic farmed Irish salmon for the beneficial promotion of cardiovascular health. The health claims that will be formulated for this nutraceutical are based on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects at very low risk of CV disease normally have non-activated circulating platelets. Decreasing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g. four weeks) would be a beneficial physiological effect". Within this study, the postprandial effects of this novel food supplement against platelet aggregation and inflammation are going to be exploited ex vivo in blood from human subjects as described in previously established procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

Outcomes

Primary Outcomes

Postprandial effect of Supplement/placebo on human platelet aggregation induced by Platelet Activating Factor (PAF)

Bio-assays on platelets will be assessed as previously described. Briefly: Standard PAF dissolved in BSA will have final concentrations 2.6e-8 - 2.6e-5 mol/L when testing into a Chronolog-490 two channel turbidimetric platelet aggregometer. The maximum reversible or the minimum irreversible PAF-induced platelet aggregation is determined as the 100% aggregation, and then various PAF concentrations are added, so as to achieve aggregations between 20% and 80% aggregation, which are of linear response to the added PAF concentration. The EC50 value that accounts for the PAF concentration (mol/L) inducing 50% aggregation of human platelets will be calculated by the equation derived from this linear curve. Results will be expressed as percentage change of EC50 on 1, 2, 3 and 4 hours of the food supplement/placebo administration, compared with baseline (0 hours)

Time frame: 2 Months

Secondary Outcomes

Postprandial effect of Supplement/placebo on human platelet aggregation induced by Thrombin

Bio-assays on platelets will be assessed as previously described. Briefly: Standard active thrombin dissolved in saline will have final concentrations 0.01 - 1.0 IU/mL when testing into a Chronolog-490 two channel turbidimetric platelet aggregometer. The maximum reversible or the minimum irreversible Thrombin-induced platelet aggregation is determined as the 100% aggregation, and then various Thrombin concentrations are added, so as to achieve aggregations between 20% and 80% aggregation, which are of linear response to the added Thrombin concentration. The EC50 value that accounts for the Thrombin concentration (IU/mL) inducing 50% aggregation of human platelets will be calculated by the equation derived from this linear curve. Results will be expressed as percentage change of EC50 on 1, 2, 3 and 4 hours of the food supplement/placebo administration, compared with baseline (0 hours).